Title of Invention

TREATMENT AND MANAGEMENT OF OBESITY AND OBESITY RELATED DISORDERS/SYMPTOMS USING CARALLUMA EXTRACTS

Abstract Doses containing pregnane glycosides alone, and in combination with several other compounds for treatment of disordersiconditions such as obesity, low BMR hyrperglycaemia, hypertension, percholesterolemia, Type 2 diabetes, migraine, osteo-arthritis and joint gradation/inflammation. clinical depression, menopausal syndrome, ageing syndrome, circulation syndrome, capillary degeneration, reduced cognitive and memory function. hearing loss, sexual dysfunction and others are disclosed. Doses are also provided for the regulation/improvement of various physiological parameters/ronditions/functions associated with said disorders and others such as skin condition, joint mobility, mood, memory function and recall, lean body mass, stamina, libido and others. The preferred glycoside is a caralluma plant extract containing a synergical mixture of the pregnane glycosides, caratubersides and boucerosides containing 90-95% of the former. Combinations thereof with tIle extracts of Green tea. Fenugreek, Ashwagandha, Shilajith, Comrniphora Mukul, GaTcinia, Hibiscus Subdarifa, Coccinia, Bittergourd, CiImamon, Liquorice, Roo clover, Hops flowers, Pomegranate and with Glucosamine, Zinc monomethionine, Citrus bioflavonoids, Rutin, Bamboo silica, Shilajith. Saponin glycosides and the bitters of caralluma, and selenium are disclosed.
Full Text

This invention relates to the uses of the pregnane glycoside(s), and tlie saponins and bitters of caraUuma species of plants, is the trcatmcol and management of symptoms/disorders such as obesity, overweight, high BMI(Body Mass Index), low BMR(Basal Metabolic Rate), hypertension, hyperglycaemia, hypercholesterolemia, osteo-arthritis, migraine, clinical depression, loss of hearing, sexual dysfunction, low stamina, endurance and energy levels, reduced cognitive and memory functions, capillary degeneration, joint inflammation/degeneration, drcuiation disorder, aging s>Tidrome, menopausal syndrome and otliers; in the alteration/ improvement/regulation of conditions/parameters/functions such as appetite level, weight, BMI, BMR, waist, arm and hip circumferences, fat levels, lean body mass, blood sugar, blood pressure(bp), total blood cholesterol, blood HDL/LDL ratio, stamina, energy and endurance levels, cognitive and memory function, hearing, aging, joint mobility, mood, sexual stamina and power, capillar^' health and others and in skin nooiishment and as an anti-oxidant, anti-inflammation and anti-depressant agent. This invention fiirther relates to n^thods of said treatment/management and of said alteration/improvement/ regulation and to jHegnane glycoside compositions therefor, said compositions optionally further comprising additional tterapeutical, nutraceutical or nutrition components. This invention also provides for processes for admixture for ma^dng said compositions.
Obesit>' is a major public health problem the world over in view of the direct and indirect economic and social costs of obesity. One of the major causes of obesit>' is the stressfiil and sedentary- lifestyles of modem life and the widespread adoption of diets that cc ^tain large amounts of high calorie processed foods. The problem is particularly acute and widespread in some industriahsed counxries.
Obesity is a direct causal contributor to the pathophysiology of a number Df diseases and causes exacerbation in several others. Some of said disoiders/syn^)toms are: diabetes, hypertension, cardiovascular disease, atherosclerosis, stroke and others.
Obesity is being increasingly combated medically by providing treatments for weight-reduction and for coping with, and managfiraent of associated symptoms/disorders spch as high blood sugar, b.p., jomt pains and otiiers.

Weight reduction and related treatments such as regulation of BMI(Bod>' Mass IndexX iacreasing lean mass, increasing BMR(Basal Metabolic Rate), ?se also being inoeasin^^ adqxed by people who are not strictly clinically obese but do so for personal or social reasons sodi as the desire to feel and look good. ITie uses/metliods/compositions of this invention are also relevant to said people.
These inventors have worited extensively on said problems/disorders and ha\'e developed novel uses of said pregnane ^ycoside(s) in the treatment and management of 6besit>" and obesitj^^^lated dfisoiders/'sjinptoms and other disorders/symptoms. According to the invention, the pregnane glycosides for said uses, may be caratuberside or bouceroside or others or mixtures thereof or may be sitiQiis and processes of this invention relate also to disordeis/symptoms and conditions/parameters^functions odier than those lelated to obesity.
It is the observation of these inventors that the pregnane glycosides and oilier constitueBte of caralluma are highly effective for treatment and management of obesity and obesity-rdated discrders%ymptoms and other said disorders. Said glycosides have been tested to be non-toxic and generally fiee of side effects. In cases where side effects were observed during the tests tl^ were onfy gastro-inte^HBsal(Gn in nature and were minimal and transient. Said side effects were generally found to cease within about a week of the commencement of treatment.
The principles of caralluma relevant to said uses and methods of this invention are said pregnane glycosides thereof. Preferably, said glycosides are caratuberside and/or bouceroside or mivtines thereof

and includes the isomers thereof More preferably, said compositions m^ mixtiires of caratuberside and bouceroside which are found to exhibit strong synergj' effects particularly with respect to their apphcations for treatment and management of obesity and obesity-related disorders/symptoms. Preferably, the ratio of caratuberside and bouceroside in compositions for said uses and said methods of the invention is from 9:1 to 19:1 by wt. Some compositions of this invention ftirth^ comprise the saponin glycoside(s) and the bitters of carailuma and/or other additional therapeutical, nutraceutical or nutritional components.
The pregnane glycosides for said uses and methods may be isolated from materials of plant origin sudi as for example, the carailuma species of plants or they may have been produced by as yet apparently unknown chemical synthesis methods. Or they may be one of the extracts of the carailuma q)ecies of plants. As the caratuberside-bouceroside ratio(CBR) found in nature in tiie carailuma ^}ecies of plants is almost equal to the value at which said synergy is a maximum it is advantageous to directfy employ a carailuma plant extract in said uses/methods of the inventioa These inventors have developed said caralliuna plant extracts and processes of making the same by 'die extraction of carailuma plant matter. This forms the subject-matter of their application for Indian patent No. 451/MAS/2003 dated 4'*' June 2003.
Thus, this invention provides for said treatment and management and said alteration/improvement/ regulation by the use of, that is, administration of said pregnane glycosides, prefer^ly caratuberside and bouceroside. This invention, therefore^ focuses on said caratuberside-bouceroside mixtures that offer considerable synergj^ and in particular, mixtures having caratuberside content from about 90% to about 95% w/w. for said uses, methods and compositions of the invention.
Carailuma plants also contain some saponin glycoside compounds which are present in small quantities and which are precursors of a number of useful products. However, their role in said uses and mefliods of the invention is insignificant except for one application discussed hereinbelow and could therefore be left substantially unextracted when preparing said carailuma pregnane glycoside extracts for the uses/ metliods/compositions of the invention. The term 'glycoside(s)' in the further specification hereinbelow. therefore, generally refers to said pregnane glycosides unless otherwise required by the context.

Caralluma plant matter also contains bitters which are also of significance medically and healthwise and some novel applications thereof are provided hereinbelow wherein said pregnane giycoside(s) includes some amounts of said saponin glycoside(s) and/or said bitters.
It would be possible to isolate any of the caralluma glycosides in pure form and then use tliem either singly or as mixtures in the said uses/methods/compositions of the inventioa Altemativeiy, said glycosides could be obtained by synthesis methods. A still further altCTuative is to obtain a mixture of caratuberside and bouceroside by extraction of caralluma plant matter(or any other plant matter containing pregnane glycosides). References to glycosides also mean reference to their isomers. Two isomers of caratuberside and ten of bouceroside are known to be present in caralluma. Within the scope of the invention, said glycosides in the uses/methods/compositions of the invention ^nay be in their unconverted forms or in tlie form of any of the pharmaceutically accepted salts thereof. Any of the pharmaceutically acceptable carriers may be used with the glycosides which may be in their converted or unconverted forms.
As mentioned, this invention preferably provide^ for the use of the caralluma extracts wherein, by carefully conducting the extraction process substantially the entire caratuberside and bouceroside content in the plant material is extracted and the said CBR value in the plant material substantially preserved in tl\e extraa. Tlie said earlier application for paten. >y these inventors proAides both a liquid form extract of glycosides in aq. ethanoi solution and solid form extract wherein the extracted ^ycosides are adsorbed on a suitable excipient. These extracts are easily convertible into any of the pharmaceutically acceptable forms for administration to subjects, such as for example, tablets, capsules, suspensions and injections. Conversion of the glycosides in tiie extracts into the form of any of the pharmaceutically acceptable salts may also be easily carried out if required and said salts are wifliin the scope of the invention. Said conversions may be carried out by an) of the known processes.
Known pharmaceutical options for treatment of obesitv'. that is, for weight reduction are: thermogenesis, lipase inliibitors and compounds that suppress app^te and/or stimulate the central nervous system(CNS).

The thermogenesis method involves the raising of the body core temperature shghtly. This increases the metabolism of deposited lipids in the body. Ttermogenesis drugs act on the brain and the tiiyroid gland resulting in said increase of body core temperature.
Lipase inhibitors work by reducing absorption of fat in the intestine system. Thus, when a lipase inhibitor is administered to a subject, the fet portion of the food consumed by the subject passes through his intestinal system imabsoifoed and is ehminated in the stools.
Appetite suppressants/CNS stimulators act by modifying the levels of neurotransmitters such as catecholamine and serotonin in the blood leading to decreased feeling of hmiger.
All three abovementioned approaches to obesity treatmoit and management have been found to have strong to unacceptable side effects.
Thermogenesis, by its nature, carries risk of sde effects such as o\'er5timulation of vital functions such as cardiac rhytlmi, blood pressure, neurotransmitter levels and the endocrine system. Subjects experience nervousness, anxiety, hypersensitivity to stimulii, insomnia and irregular heartbeats.
The side effects associated with known lipase inhibitors are GI in nature. Patients report oily and fatty stools and increased bowel movement. They also complain of urgency of bowel movement and sometimes inability- to control the same. Oily spotting may also occur between bowel movements. A yet another side effect is the loss of fat soluble vitamins jH^sent in the food. They are carried away by the unabsorbed fat into the stools. For tliese reasons, patient comphance is found to be a problem in lipase inhibitor treatments.

When appetite suppressants and CNS stimulators are used, side eflfects arise from the altered neurotransmitter function. Tliese include increased heart rate, hypertension, anxiety, mood alterations, diaphoresis, dizziness, swelling of extremities, dryness of mouth, constipation and insomnia.
Said known obesity treatments are, furthermore, contraindicated in many clinical situations sucli as hypertensive obese patients or patients sufFering from coronary artery disease, cardiomegaly and some chronic GI disorders such as Irritable Bowel Syndrome.
In conBast, as observed by th^se inventors, pregnane ^ycosides act without interfering with the digestion process or thermogenesis or neurotransmitter levels. A carailuma extract(containing the pregnane glycosides thereoO acts on the Kreb's cycle(citric acid cycle) at critical points thereof such as to inhibit fet sjntheas in the hver and other cells of the subject and oihance fat buming(fet metabolism).
These inventors believe that pregnane glycosides also act on the hunger centres in the teain and reduce the feeling of appetite. Remarkably, this action occurs in the case of pregnane glycosides without any side effects arising, as was first observed by these im^entors. Pregnane glycosides seem to siq)pTess appetite withoctt causing any significant distuibance in the neurotransmittea fimctioning unlike as in the case of the known 25>petite-suppressants. These inventors have fiirther found that pregnane glycosides also apparently increase thennogenesis without manifestation of any side effects observed with the known thermosjenesis enhancers.
Carallmna is indeed a food item that has been consumed in the past, and still a)nsumed as a food by some population groups in India its non-toxicity, and that of the pregnane glycosides thereof, is therefore well establiseied and further verified by clinic 1 tests conducted by these inventors. This invention, therefore, provides for carallmna pregnane gIycosides(and said extracts) not only as a medicinal product but also as a health-f3\Tng and health-ensuring food supplement Thus, this invention offers carailuma pregnane glycosides and other carailuma constituents also as nutraceutical products for consumption either by

themselves or in conjunction (x mivture witfea variet)-' of other food supplements, energy enhancers and otlier health products.
Caralluma is a group of succulent species fysnd v,ild in India, Afghanistan, Arabia, Southern Europe, Sri Lanka and others. Caralluma fdants are SEBSH, erect and fleshy although some species have recumbent stems. The stems are 4-grooN^ed and are firam 10-40 mm thick( 1/2" to 1-1/2"). The spines of the stems are actually the leaves of the plant Caralhsma plants bear star-shaped, fleshy flowers in a range of dark colours from purple and blade to red and drfc brown. Well over two hundred caralluma q)ecies are known. Some of the caralluma ^)ecies investigated by these inventors are; C. indica, C. fimbriata, C. attenuata, C. tubercolata, C,. edulis, C. adscsaidens, C. slalagmifera, C. nmbellata, C lasiantha and C. penicillata. Although some limited and noo-conclusive tests and animal trials appear to have been done in the past on some medicinal pn^itics of csalluma, no tests, animal trials or human clinical trials appear to have been conducted on the «;^[>etite-suppcession property or on weight reduction and other obesity symptoms related properties Ti^)toms mc^oned hereinabove.
This invention therefore, is sq^paieady first BO establish the appetile-sui^xession, weight reduction and related properties of caiallunia extracts relevant to treatment and management of obesit)' and obesity-related disorders/symptoms and other said disorders/symptoms and also the properties relevant to said aUeration/regulation/inq>rovanent of said conditions/parameters/functions. The properties have been established by carefully designed and conc&icted animal trials and subsequently clinical trials on human subjects. This invention is also first in cosrelating said properties to the pregnane glycosides contained in the caralluma species of plants and to oth^ members of the pregna lie gfycosides group.
fhus, this invention provides for novel uses of caralluma glycosides and/or said caralluma extracts in tlie treatment and management of obesity and Gft>esit\' related disorders/symptoms and other disorders/symptoms wherein said ^ycosides and/or extracts are administered to achieve weight reduction, reduction of BMI, reduction of faL reductBom in waist hip and arm circumferences, reduction of blood

glucose, reduction of blood pressure, increase of lean body mass, increase of BMR, reduction in blood cholesterol, enhancement of the blood HDL/LDL ratio, appetite siq}i»ession, enhanced stamina, energy and endurance levels, improved hearing, imjHOVvd capillary health, improved cognitive sad memory function and/or for traitment and management of clinical dq}ression, migraine, osteo-anhritis. aging syndrome, menopausal syndrome, mood elevation and joint inflammation and to inqx^^ve/regula^ these parameters/conditions/functions.
According to the invention, therefore, there is {»^ovided the use of pregnane glycosidc(sXPG) in the form of extracts of the caralluma species of plants or otherwise, ddier singly or as nuxtures thereof, in the treatment and managem^it of syn:q>toms/disorders such as obesity, mi^aine, osteoarthritis, overweight, clinical depression, hearing loss, sexual (h^filnctiMi, hi^ BMI, knv BMR, hyperglycaemia, hypertension, hypercholesterolemia, low stamina, endmancc and energy levels, reduced cognitive and mem(Hy functions, capiUaiy degeneration, joint inflammation/S^eneration, menopausal syndrome, aging syndrome, circulation ^ndrome andotter^ in the alteration/improvement/regulatiou of parameters/conditions/ functions soch as appctist le\^, weight, BMI, BMR, v/aist, arm and hip circumferences, fet levels, lean body mass, blood sagas; blood pressure(bp), total blood cholesterol, blood HDL to LDL ratio, stamina, eoCTgy and eadurance le\'els, cognitive and memory function, mood, circulation, c^illary health, heaiiug, aging, jcral mobility, sexual power, drive, stamina and libido; and in skin nourishment and as an anti-oxidaso. anti-inflammation and anti-depressant agent, said treatment and management and aheraticx^/ improvement/regulation comprising the administmtion of an effective daOy treadnen^main) dose(s) thereof to the subject over an adequate period of time f
According to the invention, there is further provided methods for the treatment and management for said disorders/symptoms and for the alteration/improvement/regulation of said paran^'^ters/fimctions/conditions mentioned hereinabove.
Still further, according to the invention, there is provided pharmaceutical compositions containing pregnane glycoside(s) in the form of extracts of the caralluma species of plants or otherwise, for the treatment and management of said disorders/symptoms and for the alteration/improvemcnt/regulati(Hi of said parameters/functions/conditions, comprising said pregnane glycoside(s) and q>tionally including therein the saponin glycoside(s) and/or the bitters of the caralluma species of plants and furthermore, optionally comprising one or more additional therapeutical, nutraceutical or nutritional components. Still further, according to the invention, there is provided processes of admixture for making said pharmaceutical compositions.
This invention also provides for novel food supplement com4)ositions containing said glycosides and/or said extracts for use in regulation of weight and other said obesity-related parameters and other paramelers/functions/conditions. In addition to said glycosides and/or extracts, said siqjplements may comprise first, second and further addition^ components that enhance the p^orraance of said glycosides and/or extracts, synergistically or otherwise, or that complement said extracts/glycosides in terms of the action thereof on one or mere of said symptoms/disorders or parameters/functions/conditions or in providing additional nutrition. This invention provides for novel uses of said food supplement compositions and for methods of use thereof Within the scope of the invention said supplements may contain one or more said additional components, tliat is, in addition to said pregnane glycoside(s).
The said uses and metliods of this invention may be adopted for control/regulation of one or more said pai anieters/conditions/fiinctions to particular, or desired values and also to correct those that have deviated and require to be brought in hne with tl>e said particular/desired values.
This invention has found that per day dosage of between 10 mg. to 1500 mg. of caratuberside or caraiuberside-bouceroside miMiues do not exhibit any toxicity or side effects except for said transient

effects experienced by some subjects. In ilie clinical trials that are described further hereinbelow the dosage followed was 300 mg. per day of said caratuberside-bouceroside mixture, the ratio of the two said components(CB Ratio) therein being from about 9:1 to about 19:1. Subsequently higher doses of about 450 mg. per day per subject were adopted. Increased doses resulted correspondingly in increased change in the parameter(s), all other things being equal indicating that the two were generally proportional. These inventors observe that this proportionaUty of doses and effects extends upto at least 1500 mg. per day doses. Thus, this invention provides for designing the said doses to obtain desired speeds of transformation of said parameters/functions/conditions-
Said doses may contain said glycosides in the unconverted forms or otherwise. Said glycosides, converted or unconverted may be associated with any of the known pharmaceutically accepted carriers and excipients and furthermore be in the form of any of the pharmaceutically accq>ted salts. Tlie compositions may include an)^ pharmaceutically acceptable and/or edible colouring agents, flavouring agents and other additives.
The linkage between the pregnane glycosides and the effects thereof in said treatments and management and said alteration/improvement/rsgulation is established by the said animal tests and clinical trials conducted by these inventors first in India and then in the USA. TTiese provide statistical evidence confirming said therapeui ^ and health effects thereof
Said tests/trials were conducted at established and recognised medical institutions. In India, the trials were done at the St John's Medical College & Hospital at Bangalore, India under the direction of Prof Dr. Anura V. Kurpad, M.D., FLD., Dean, Institute of Population Health & Ginical Research, Bangalore, India. The US trials were under Dr. Ronald W. Lawrence and Dr. Suneeta Qiaudbaiy of the Western Geriatric Research Institute, Los Angeles, California, USA. At the completion of the test at Bangalore, India the subjects expressed desire to continue with the carallimia extract doses. Said tests and the extended Bangalore tests and other tests have established the effecti% eness of caraltunia glycosides in reducing/eliminating arthritic pains/aches, reducing blood sugar, reducing BP and efFecting changes in other parameters/fimctions/condition mentioned hereinabove. They have established the efticac\' of

pregnane glycosides in die treatment/management of said obesity-related symptoms/disorders and otlier said disorders/symptoms and in .the said alteration/improvement/regulation of various parameters/ functions/ conditions.
A mutagenicity study(Reverse Mutation Test on Caralluma extract) by Salmonella typhimuhum was conducted by M/s. Intox Private lAl, of Dist. Pune, Maharashtra, India under Dr. P.Y.Naik, Director and Dr. N.S. Deshmukh, Study Director. The study was in accordance with the OECD Principles of Good Laboratory Practices(OECD, 1998) and OECD Guidelines for Testing of Chemicals, Section 4, No. 471 adopted 2 i July 1997. The stuity concluded that Caralluma extract is Non-Mutagenic in Salmonella typhimuhum strains TA 1535, TA 97A, TA 98, TA 100 and TA 102.
A report on the risks and efficacy of caralluma extracts based on the abovementioned animal and human
studies and other evidence on car^luma was commissioned from Dr. Kany T. Preuss, M.D., M. A.C.N.,
C.N.S., Prof Of Physiology, Medkine and Pathology, Georgetown University Medical Centre, Washington
DC 20057, USA. Said rqwrt notes:
i. the absence of any adverse event reports on caralluma from the Indian subcontuiental area where
caralluma has been a past of the food chain for several population groups over hundreds of years,
the average daily intake by said population groups ranging from about 100 gms. to about 400
gms. of caralluma planl matter,
ii. that apparently no alteration of the chemical na ue of the caralluma principles occurs during the
process of extraction of the plant matter by aq. ethanol,
iii. the heav}^ metal cont^t of caralluma extracts was found lo be quite low and well within limits
based on several separate investigations,
iv. tliat various tests indicate extremely low amounts(well within safe limits) of hexane, methanol,
2-propano)ol, chloroform, 1,4-dioxane, methylene chloride and trichloroethylene in caralluma
extracts,
v. tliat the said 2 month long test programme at Bangalore, India referred to hereinabove is
suggestive of weight loss althougli the differences were not significant in magnitude. However,

that there was a significant drop in waist circumferences suggesting that a part of the tat loss
must iiave been masked by muscle build-up,
vi. that tests on various categories of diabetic mice clearly shew significant lowering of blood
glucose levels through an 'insulin-Uke' action, that is, by increased release of insulin and/or
sensitisation of the animal to lesser amounts of insulin, vii. that caralluma extracts have anti-nociceptive and anti inflammatory action in addition to anti-
hyperglycaemic property.
Tlie mechanism of action of caralluma glycosides in producing said effects is not at present fiilly understood and requires more work to ascertain and establish the aene. However, the general outline of the mechanism are prcq)0sed herein by these inventors and in this context these inventors make the undermentioned observations. It may be noted that this is without commitment by this in\'ention to any specific mechanism or nuxie of action. It may be relevant to mention again at this point that the link between said caralluma glycosides and said effects is conclusively established by the statistical evidence provided by said tests/trials.
The biochemical processes of carbohydrate, protein and fet mdabo&m and of the breakdown and biosyntliesis of fats relevant to the subject of this invoiticm are summarised below.
i. Carbohydrates, proteins and fats are broken down in cells to generate energy in the form of energy carrying molecules such as ATP(Adenosine triphosphate). Said breakdown also produces p\Tu\ic acid that dififuocs into the mitochondria where a series of reactions produces, inter alia, acetyl coenzyme A and oxaloacetate. Com x)unds NAD and FAD are also produced. They carry activated hydrogen atoms that subsequently take part in fat svnthesis reactions. A further reaction finks acetyl coenzyme A and oxaloacetate to give a molecule that is c^5able of diffusion across the mitochondrial wall into the cell MT cytoplasm. The NAD and FAD also diffuse out into the cytoplasm where tcgethCi with acetyl coenzyme A the)' undergo various reactions ending with synthesis of fat molecules.

ii. In the cytoplasm an enzyme called citrate lyase catalyses the breakdown of said combined molecale into its constituent parts, oxaloacetate and acetyl coenzyme A. The action of citrate lyase is critical in that blocking the action thereof would prevent formation of acetyl coenzyme A in the cytoplasm and tliereby disrupt the fat synthesis process in the cells.
iii. The precursor(builiithesis in cells and if the production thereof is eitter prevented or restricted, the fat synthesis is similaTiy afiFected.
iv. Both &t breakdowxi(£at n^tabolism) and fat synthesis occur simultaneously in cell cytoplasm particularly in hver cells. The &t breakdown is promoted(catalysed) by an enzyme called carnitine acyltransferase. Relative levels of carnitine acyltransferase and malonyl coenzyme A determine the balance between the twin reactions of fet synthesis aiKl breakdown, more of one promoting one while more of the other promoting the other.
V. Acetyl coenzyme A is also consumed in the mitochondria to g^ierate/release energy. Only when
tlie energ>' requirements of a cell are met that excess acetyl coenzyme A gets formed that migrates to the c}tpplasm where it partakes in fat synthesis as mentioned above.
vi. An important faaor is the feeling of satiety/hungw that arises in the hypothalamus. The hypothalamus receives signals from the stomach conveying the position, that is, the fulhiess or otherwise of the stomach. This is translated into the appropriate feeling of himger or satiety in the brain. Via another channel the brain also receives signals indicating the posit '(m about glucose and glycogen levels in the liver. If these lev els are high, they generate a feeling of satiety in the brain and vice versa.
Tnis invention observes that pregnane glycosides block the action of said enzyme citrate lyase and'cr direct its aaion av^ ay from splitting the combined acetyl coenzyme A-oxaloacetate structure. The resultant drop

of acetyl coenzyme A levels in the cytoplasm decreases 6t synthesis. These inventors further believe that pregnane glycosides inhibit the action of malonyl coenz>tne A in fiu synthesis. Thus, caralluma glycosides provide two-fold action in decreasing &* s>iithesis: ooe by decreasing the formation of malonyl coenzyme A and the other by inhibiting the action of malonyl coeoz^ine A generated.
Decrease of malonyl coenzyme A levels shifts the malonyl coen^Toe A-camitine acyltransferase balance in favour increased fat breakdown as opposed to fat s>Tithesis. Thos, under the effect of pregnane glycosides a body not only decreases fet SNiithesis but spsods i^ fid breakdown(fat metabolism). The effect is greater release of energy, that is an enhancement of BMR. The latter effect is more sigiiificant because the scope for decrease in fat s^Tithesis is quite small in view of the fact that the amoimts of M synthesised by a body in a day is, in any case, a small quantity. The increased fat metabolism and the increase of BMR makes a subject feel more eneri^tk; ui£ke as la die case of the known ai^tite suppressants and, as will be observed from die fiiidier These inventors also found that pregnane glycosides also act on tie h>pothalamus to generate a feeling of satiety and well-being and reduce the feeling of hunge-. This oocors without any side effects such as those associated with known a{q)etite-sup|xessant&. Pregnane ^hpcosides also act in the liver to direct the lipids towards glycogen productioa Increased ^ycogsn level also contributes towards the reduction in the feeling of hunger felt by a subjecl.
Tlds mechanism of the action of pregnane glycosides in relatiao ID obesity and obesity-related symptoms/'disorders and parameters/'conditi
The basis of said effects in relation to obesit>' and obesity-related symptoms/disorders is the appetite-reducing, tlie fat syntliesis disruption, the fat metabolism increase and other properties of the pregnane glycosides. Specifically, the obesity and obesity related fimctions/parameters/conditions/disorcfcrs/ symptoms that are affected by pregnane glycosides are: weight, obesit>', BMR, BMT, blood sugar. BP. blood lipids, appetite, lean body mass, waist, arm and hip circumferences, joints and others. Otho' properties of pregnane glycosides that come into action are: inqHX>ving capillary health, anti-inflammatory, anti-oxidant and others.
The further description given hereinbelow establishes the said effects of the pregnane ghcosides as regards several other non-obesity disorders/symptoms/fimctions/conditions/p^ameters. With regard to o^eo-arthritis and joint degeneration/inflammatiou, these inventors observe that the action of pregnane glycosides is very significant as it provides not only reduction/elimination of said inflammatioa but also improvement in the health of the joints by reducing/reversing the degen^ation of the bone and synovial tissue. Pregnane glycosides have both anti-arthritic and anti-inflammation prq>erties. Caralhima extracts, furthermore, cause increased secretion of the synovial fluid whidi increases joint efficieDcy and mobility. With pregnane glycosides, morning stiffness is eitiier reduced or eliminated and the jfoints feel stronger and are able to take up greater loads.
With regard to clinical depression and mood elevation, these inventors observe that pregnane ^ycosides acE through intei-vention in the neurotransmitter levels. This has not been c*served/reported in pvkrr an Ttie cormection between pregnane glycosides and clinical dq>ression mi in mood ele\:ation w^s first observ^ed by these inventors during said clinical trials on the ^^>etite-suiTOession and weight reducing properties of caralluma extracts. It was observed that sidyects taking the extracts experienced an increased feeling of well-being, enhanced energy levels, mood elevation and increased tolerance to pain and stress. Clinical depression is characterised by pathological changes in nemotransmrtter fuoctioii. especially catecholamine levels. Significantly, low levels of serotoiun(5 hydrox\tr>-ptamine. 5HT) ba\'e been demonstrated in neurochemical disorders like clinical depression, obsessive-compulsive disorders, social phobia and hypochondria. Serotoran is also apparentiy involved in the sensation of hunger. These inventors belie\ e that through its effect on the neurotransmitter serotonin and others in the supjpression of

appetite, pregnane gl>^coside(s) is able to simultaneously provide mood elevation, increased ability to cope with stress and greater social interests. Unlike the known anti-depresssants of the SSRI class(Selective Serotonin Reuptake Inliibitors), pregnane glycosides do not have cardiovascular side effects or others such as dysrhythmia and hvpertension. Adoption of SSRI*s often results in serotonin intoxication unlike in the case of pregnane glycosides. Serotonin intoxication can cause aggressive/violent or erratic behaviour, insomnia and hyperactive state in subjects.
One of the most common form of sexual dysfunction is primary impotence,, that is, erectile dysfunction(ED). ED is caused by various psycho-physiological factors including depression the eflFect of which is to restrict or decrease blood flow to the erectile tissue in the penis which is known as the corpus cavemosum. While nitric oxide in blood relaxes the muscles in the penis to let more blood flow in, a phosphodiesterase enzyme called PDE5 inhibits the action of the nitric oxide. Known treatments of ED are based on administering PDE5 inhibitors. However, the action of PDE5 inhibitors is quite slow and furth^more has adverse cardiological efifects. It is contra-indicated in cardiovascular patients and for people suffering from low or high BP particularly those on nitrate-based vasodilators. PDE5 inhibitors are also known to induce depression, which itself is a known causai factor in ED. The tests conducted by these inventors have demonstrated that pregnane glycosides increase energy levels in subjects; cause mood elevation and a feeling of well-being. The anti-depressant propertiss of the pregnane glycosides are also relevant in this context These inventors observe that while ptegnane glycosides are not known to cause directly increased lood flow to the penile tissue, they may be causing the same to happen by virtue of the mood-elevation, energy-enhancing, capillar}^ health restoring and anli-dq)Fessant properties thereof as the said tests confirm improvement in sexual function in subjects suffering from ED. Increased fluid secretion in the male and female reproductive organs was also observed by the inventors. In female subjects, particulariy those suffering from age and/or menopausal syndrome, these inventors found that pregnane glycosides generated resurgence of sexual interest and increased hbido.
Memoiy impairment and reduced retention are related to d^ Deurotrasmitta* levels in the brain, in particular serotonin levels. Pregnane glycosides, as observed by these inventors, cause enhancement of energy levels, libido and gastro-intcstinal motiUty. Thev also cause mood elevation. The resultant

increase in serotonin levels g^ierates a feeling of well-being, increased perception of pain and stress, increased memoTV recaU and retention, increased speed of retrie\'al and augmented cognitive function
This invention has observed ttat pregnane glycosides cause a reduction of total cholesterol in subjects and
also an increase in4he HDL/LDL ratio. The mechanism for this action is not understood but the effect
mentioned has been demonstrated by the clinical tests described hereinabove.
In the case of migraine attadcs, these inventors have found that pregnane gjiycosides decrease inflammation
and pain and increases tolei^ice to stress and pain. This invention has found that pregnai^ glycosides
increase capillary elasticity and in general ensure capiillary health. The anti-depressant and mood
elevation property of pregnane glycosides gives a psychological boost to the subject and the higher
serotonin levels generated by the glycosides increase the confidence level of the subject in facing u|^o the
migraine attack.
These inventors Fqx)ri that pn^nane glycosides enhance eneigy levels, oiduiance levels and increase
stamina as outlined in the description hereinabove. Hus action of pregnane glycosides together with
reduced fat synthesis and increased fat burning helps buiW iq) musde tissue. Thus, this invention
provides for administraticm of pregnane glycosides for building \xp the lean body mass Pregnane
glycosides and their formuiations are therefore, good diet adjuncts/supplements in sports and athletics
training schedules.
As regards diabetes, these inventors observe that preg. ane glycosides exhibit dual action: reduction of
weight and effect on ttie hi»d metabolism and reducing/regulating blood sugar as established by the said
tests/trials. The clinical trials have also established the anti-hypertensive and anti-cholesteiolemic
properties of caraiiuma extrads.
These inventors observe that in view of the energy, stamina and endurance enhancing properties of
caraiiuma and its property of restoring elasticity to capillaries and its anti-oxidation action is relevant for its
use in the treatment of the aging syndrome.
The role of pregnane glyco^d^^iitc^^sr^ regisneration and protection has been mentjooed (hereinabove.
This forms the basis for tfier^mgy'rf^qsc^reof in tre^t^ raiiiMifcj- lAyuiSfation and maintaining capillary
health as provided by this inventi^

The role of pregnane ^ycosides in regenerating capillary walls is also the basis for the novel use of pregnane glycosides in treating loss of hearing as provMed ty this invention. Pregnane glycosides restores capillaiy health in the ear region which leads to improveircnt in the hearing function. Said regeneration of capillaiy walls helps increase/r^l The connection between pregnane glycosides and capiliaiy health is also the basis of the novel use thereof m skin nourishment as provided by this invention. Thus, pregnane ^^'cosides can restore and maintain skin health such as of the face, arms and other parts of flie body.
1 lie intake of carallunia glycosides by p mortality in rats upon administratian of a very high dose of 5 gms. per kg. body weight of caralluma fimbria extract containing about 50% wAv of pregnane glycosides. No fetahties or adverse effects were noted. These data indicate that the toxicity limit if any of pregnane glycosides is quite high and may be well above 5000 mg. per day for hi Tians. This also establishes that accidental overdoses of pregnane glycosides(or caralluma extracts) do not pose an>' risk.
The clinical trials programme done at the St. John*s Medical College and Hospital, Bangalore, India was double' blind, controlled and randomised and followed the guidelines of the Indian Council of Medical Research, New D ;lhi, India with regard to methodology and ethical considerations and other factors. Sixiy-two obese subjects wee selected at random for the test, fifty of who completed the test, the rest having dropped out during the test. Half of the subjects who coiqdeted were on active medicine and the rest were on placebo.

Each subject was examined at the commencement of the trials and then at the end of tlie first and second months. The examinaticm included anthropometric parameters of body weight, waist circumference, MAC, hip circumference, Fat%. BIA Fat% and lean% and a series of biochemical measurements including blood sugar, lipid profile aid others. The subjects were questioned about hunger level, vagQ to eat, fiiUness and thoughts on food and their responses recorded.
Both parametric(paired 'f liest) and non-parametric tests such as Wilcoxon Signed Rank test(paired analysis) and Mann-Whitaey tesl(for unpaired analysis) were used to look for significant changes between time points and between tbe groups. Both parametric ar i non-parametric tests gave similar results.
In groupwise analysis, the Wilcoxon-Signed Rank Test was used to check differences between time points separately in each group. Ilie significant values were based on p In the inter-groap analysis, difierences in change in each parameter were compared between the groups using Ndann-Wbitnev' test for independent compari^ns. Significant differences were taken where p The overall conclusions from the trials are that statistically significant differences between time points were seen in the acti\'e group tar the parameters of body weight, BMI, waist circumference, hip circumference, fat loss, blood pressure ajid himger levels while blood sugar and lipid profile did not show any significant
results.
Tlie doses adnnnisteied to the subjects consisted of an extract of caralluma fimbriala. The aerial parts of the plant \^'ere extracted 'with 30% vA- aq. ethanol. Resin removal was done with n-hexane solvent. This >ielded the caralluma glycosides in aq. ethanol solution. This was concentrated and adsorbed on a suitable excipient Tlie material was then dried and fiUed in hard gelatine c^sules. The dried, adsorbed

material contained either about 25% or 50° o wAv glycosides. Each c^)sule contained 500 mg. of the said excipient adsorbed extract containing either 25% or 50% w/w pregnane glycosides giving capsules of two strengtlis, single and double. The subjects lock two capsules a day, one before each meal. The capsules given to tlie placebo group did not contain the e.\tracL For some te^ involving low value doses, capsules containing 250 mg. of said extract containing 25% and 50% wAv pr^iane glycosides were used.
The adverse effects observed were GI(gaslro-imestinaI) in nature and -were reported in both the groups, active and placebo. TTie effects were moderate acidin', miW constipation and mild to moderate flatulence and subsided within a week of commencement of trials. No adverse effects were noted in other syttemic functions. No changes in ECG were obsen'ed. No s>Tiq>adK)miiQedc effects were found.
The American study by Dr. Ronald LawTence and Dr. Suneeta Chaodbaiy at the Western Geriatric Research Institute, Los Angeles, California, USA was done im 26 xaadomly selected overweight patients of whom 19 were placed in the active group while 7 were on |rfacdx>. The trials were done over a 4-week period.
The subjects were taken from two active practices in the Los Angeles area and randomly assigned to tlie two groups. The age profile varied from 31 to 73. Two subjects decpped out during the tiials leaving 24 to complete the test
The following parameters were measiu*ed before and at the end of tticte^: weight, height, hip and waist circimiference and b.p. All the subjects were adxised to pursue tKnaal pattern of activity, exercise and food intake and not to alter their diets during the test.
The active group were given gelatine capsules containing an extract of Caralluma fimbriata. The capsules for the placebo did not contain the extract. The sid>jects wexe asked lo take two capsules a day one prior to each meal. The active capsules contained 500 mg. of ihe extract eadi, said extract containing about 50% w/w of pregnane glycosides.

Tlie extract incorporated in the capsules administered in the US study was prej^red as follows. Aerial parts of Caralluma fimbriata were extracted with aq. ethanol and thai the extract was subjeaed to resin removal. The extract was th^ concentrated, adsorbed on a suitable excipient and the material dried and then incorporated in gelatine capsules.
The American study concludes that administration of Caralluma fimbriata extracts used in the weight reduction programme coupled with no change in daily activity pattern and diet of the subjects resulted in a statistically significant weight loss over a period of only four weeks. Tlie study noted the lack of toxicity and the absence of any side effects. The study recommends further trials and ^ates that there are few, if any over-the-counter natural substances which can produce such a weight reduction effect At the conclusion of the Indian study, the subjects expressed a voluntary desire to continue with the caralluma glycosides doses. The study wsis therefore extended and has alreacfy run over 12 nnxiths azid is continuing. This has proved advantageous as the period of the earlier study was only two months. In the continuation study, the dosage has been increased to three capsules a day in a two-pius-one ^^em. Tbe increased dosage and the longer period have given some important insists that were not apparent easlier. Thus, while the earher tesl did not show statistically significant effects as regards the blood sugar of die subjects, the link was clearly evident from the results of the ext^ided study. The ext^ded tests hav« established that administration of pregnane ^ycosides does lead to reduction of biood sugar levels, reduction of BP, redaction of serum cholesterol and reduction of LDL together with enhancement of HDL cholesterol in blood.
This invention has considered several said additional components that may be added to or taken in conjunction with the pregnane ^ycosides. These are described hereinbelow.
Garcinia(Garciiiia cambogia) extract is a known weight reducing agent. It has been used as a food supplement in India and China over hundreds of years and its non-toxic nature is well established. The active principle of Garcinia cambogia is (-)-hydroxycitrate, or HCA.

HCA suppresses appetite a ad inhibits absorption and biosynthesis of fats, cholesterols and triglycerides. A dose of 3 mg. of HCA per kg, body weight is known to cause about 43% reduction in appetite at 6.5 hours and about 29% at 24 hours and is prefer^ly taken 30 to 60 minutes before meals. The appetite reduction effect is dose dep^ident and no rebound eating is observed upon sto]q>ing of tte dose.
The effect of HCA on the brain and the neurotransmitter system in reduction of appetite does not appear to have any side effects. HCA also acts in the upper digestive tract in reducing fat absorption and during the Kreb's cycle to reduce fat biosynthesis. HCA also acts in the liver and diverts carbohydrates from lipid biosynthesis to hepatic glycogen SNuthesis that also contributes to the feeling of reduced appetite.
It will be observed that there are considerable simMarities in the action of the pregnane glycosides and HCA in appetite suppression and weight reduction Tliis invention therefore, provides for mixtures of pregnane glycosides(or caralluma extracts) and Gardnia extract(or HCA). Said mixtures have been observed by these inventors to exhibit synergy in the treatment and management of obesity and obesity related symptoms and disorders and in said alteration/improvcment/regulaiion of the (Aesity related parameters/ccnditions/fimctions such as weight, BMI, BMR, waist, hip and arm circumferences, lean body mass, appetite suppression and others. Said mixtures increase lean body mass by stimulating thennogenesis without any side effects. Said mixtures also mildly reduce systolic and diastolic iM'essures and reduce cholestert,' by inhibiting its production in the liver.
Glucosamine is known to be used for treatment and reUef in arthritis. It gives strength to the cartilage and rigidity to the joints. The^ inventors found that mixtures of glucosamine with pregnane glycosides(or caralluma extracts) is s>Tiergistic in the treatment and maintenance of joint health. Said mixtures enhance the synthesis of new cartilage and inhibit the action of the cartilage destroying enzymes. The combination is far more effective in reducing joint pain and inflammadon and in enhancing joint mobility' than the sum of the actions obtainable individually by the r\vo components. Glucosamine may be in the form of the sulphate or any of the other pharmaceutically accepted salts in the compositions disclosed herein

Rutin is a bioflavonoid that has been i^ed in the treatment of arthritic pain. Rutin is a capiliary protectant in that it restores elasticity to capillary walls. Ajplication of Rutin restores blood flow to joints and thereby enliances secretion of the synovial fluid. One of the other bioflavonoids may also be used: Hcsperidin, Diosinin or others. This invention found synergy in mixtures of pregnane glycosides and Glucosamine and Rutin, mixtures of PG and glucosamine and in mixtures of pregnane glycoside and rutin and provides such mixtures for the ti^tment and management of osteo-arthritis and in the reduction/elimination of joint inflammation and pains. Said mixtures may also include Chondroitia Both Glucosamine sulphate and Chondroitin sulphate are acidic and therefore mixtures thereof with pregnane glycosides are j»c3blematic for subjects who suffer from gastric acidity. For such subjects, this invention provides for mixtures of pregnane glycosides and Rutin or one of the other bioflavonoids.
Green Tea extract has been known for use as an anti-oxidant, anti-aging, aiiti-microbial, anti-viral, anti-fimgal and an anti-cancer agent. It has been also used in plasma diolesterol control and for control of blood glucose and insulin levels. Green tea extract also inhibits the accumulaucm of &t in the body and the liver in particular. Its pre-emincm use is as an anti-aging aguit. Pregnane glycosides are also anti-oxidation agents in their own right Pregnane glycosides provide energy boost, prevent/minimise joint pains and ensure capillary health. Green (ea contains polyphenols that are also referred to as catechins. The major catechins in green tea extracts are: Epicatechin, Epigallocatechin, ^igallocatechin gallate(EGCG) and Epicatechin gallate. EGCG is the stronge t anti-oxidant of the foiu* and is kno\vn to cure free radical damage, prevent bacterial infection and reduce cholesterol. These inventors have found that mixtures of pregnane glycoside together with the saponin glycosides found in caralluma and green tea extract are synergistic with regard to treating and figjiting the aging syndrome, inamtaining youthful elasticity in tissues, in slowing down or preventing cataract formation and for increase of stamina, energy and endurance and BMR. Said mixtures are excellent anti-oxidant and anti-aging agents.
Ashwagandha(Witiiania somnifera) is known as an aphrodisiac and sexual potency- enhancer. Tliese inventors observe that pregnane glycc^des are steroidal in nature with close resemblance to sex hormones and believe that pregnarie glycosides may be the precursor or a link in the svntliesis of \ital sex hormones

in the body. This invention has discovered that combinations of pregnane glycosides and the Avilhanolides of Ashwagandha are syner^stic in respect of their application as s^rfirodisiacs and enhancers of sexual power and potency. Said application as aphrodisiacs and for increasing sexual p(rtency and power relates to both sexes. This invention, th^efore, provides for said combinations for enhancing sexual power and potency, as aphrodisiacs, for improvements in the functioning of rqwoductive organs in both sexes and for treatment of ED. Tliese inventors observe that compositions of pregnane glycosides and Ashwagandha are anti-depressants and are provided by this invention for treatment jmd managranent of clinical depression.
Shilajith, also known as Asjdialtum or Mineral pitch, is a strong afdirodisiac and sex drive enhancer. This invention reports that mixtures of Shilajith and pregnane glycosides also exhibit synergy. This is in respect of application of the combination as an aphrodisiac; for curii^ pnmaiy impotency and for increasing sex drive and libido. Mixtures of Shilajith and pregnane glycosides are pro\ided by this invention for said application.
Fenugreek extract is known to be effective in reducing blood sugar and is used in anti-diabetic formulas. The component therein which is active in this respect is 4-hydroxy-iso-leucine. This invention explored mixtures of fenugreek extract and pregnane glycosides together witii tiie bitters of caralluina for application in reducing blood sugar, in partiailar FBS(Fasting blood sugar) and found that such mixtua exhibit sjnergy and are highly effective in reducing and controlling blood sugai*. Said mixtures are very relevant for Type 2 diabetic subjects and for those desiring reduction and/or r^ulation of blood sugar. Both the components are consumed as food products and are therrfme, totally non-toxic and safe even at ver\ higl\ doses. T'lese inventors have found that as the dosages are increased the FBS reaches a floor ]e\d of about 70-80 mg./dL ai?d does not fall below the said level. A combination of about 250 mg. of caralluma extract containing about 125 mg. of PG together with 250 mg. of Fenugreek extract containing 40% 4-hydroxy'iso-lcucine taken over a period of about 6 months brought the FBS down from about 160 nig./dL to about 80 mg./dL. Tliis invention therefore, provides a mixture of pregnane glycosides, fenugreek extract containing 4-hydroxy-iso-leucine, Coccinia extra
gourd extract containing about 8% biiiei^ and Cinnamon extract containing about 15% polyphenols for reduction of blood sugar.
Fenugreek also contains Protodioscin ilxat is a precursor to many sex hormones including Androgen that stimulates sex urge in men. The role of pregnane glycosides in treating sexual ^sfimction and for increasing sex drive, power and stamina and enhancement of libido has been discussed hereinabove. This invention finds that combinations of pregnane glycosides and protodioscin are ^iiergistic in treating the aspects of sexual dysfunction n^ntioned hereinabove. Thus, this invention jMxnides for mixtures of pregnane glycosides and fenugreek extract containing about 50% protodioscin for said treatment for sexual dysfunction symptoms and/or for enhaadng sex drive, power, stamina and tibido. This invention provides for an anti-cancsr composition that neutralises certain carcinogens and comprises pregnane glycosides with Snc monomedrionine, Citrus bioflavonoids ^vith selenium as selenium chelate. Said mixture exhibits synergy.
Another novel composition comprisingttie same components, namely, pregnane glycosides together with Zinc monomethionine and Qtrus biofknronoids and Selenium as selenium chelate is provided by this invention for the treatment and managesnent of the menopausal ^ndromc. Said composition, which is also synergistic, provides rehef from he* flushes and menopausal distress.
A yet another novel composition comprising pregnane glycosides along with Zinc monomethionine, Citrus bioflavonoids and Selenium as seleniusa chelate is provided by this invention for skin nourishment. Said composition exhibits synerg>' and t)roiects cell membranes and tissues and ensures capillaiy health It is helpful in maintaining youthful elasticiry in tissues by preventing the hardening thereof It is an excellent anti-aging and anti-oxidant oamposition. It also slo\^s/prevents formation of cataract. The selenium in the aboN'emeniioned nuxtnrss mav also be as sodiimi selenace or selenomethionine.
A few other said additional coroponems incorporated in cOfi^ftoiSitonS provided by this invention are:

Coccinia extract containing about 10% t^pcnes. Bitter gourd extraa contansimg about 8% bitters. Hibiscus Subdarifa extract containing about 25% polyphenols. Cinnamon exiiact cooEaming about 25% polyphenols, and Commiphora Mukul extract containmg about 3% gugulsterones
A few plant extracts contain components that suR)lement or enhance estrogesi levels in women and are therefore suitable for treatment of menopausal s\Tidrome wherein wxxnen sa^x hot flushes, depression, night sweat, irritabiUty emotional changes and other symptoms. Combinatkaais of diese plant extracts and pregnane glycosides were found by the present inventors to offer S|siiergy in ©eatment of menopausal problems and in lowering the risk of cardiovascular disease and osteoporosis m post-menopausal women. Said plant extracts are: Liquorice extract containing about 5% TriplMoestrogai, Red clover extract containing about 8% isoflavones. Hop's flower cxtt^a containing about 5%ls^h\'toestrogen and Pomegranate extract containing about 10% EUagic acid-Bamboo silica is known to help in osteo-arthjitis. Tins invention has also iaaiwestigated mixtures of pregnane glycosides with Rutin and bamboo silica and finds them syn^rgic^ mod boieficial in the treatment and management of joint degeneration and inflammation. A mixture of said pregnane glycosides together with glucosanfiine and Rutin and furthermore containing bamboo silica is alsc^ |m)\ided by this in\'ention for the treatment atd management of joint problems and for maintaimng joisss beahh and flexibility.
With regard to the various treatments referred to hereiEi. the following clarifications are made.
i. The pregnane glycosides content of the doses mentioned herein has fceen ^cified in terms of the
weights of the molecularly equivalent amounts of the pregnane glycaside, caratuberside.
ii. The Glucosamine content of the various doses mentioned herein has been ^^)ecified in terms of the
weight of the sulphate salt thereof
iii. All the compositions defined and claimed herein have been found bv ^e inventors to exhibit'
synergy.
iv. Where plant extracts having a certaiii concentration of fte active priiaaples thereof have been
specified as components of said doses, it ma>- be noted fliat odier sakS conc^trations are within the scope of the invention as the same can be adapted for the dose by simple adjustment of the quantities going into the doses. For example. "
concentration may be used and the amoimt of the component in the dose adjusted to take into accomit tlie concentration difiference,
V. This also apphes also to non-plant components, if ai^^.
vi. Unless otherwise specified, the maintenance doses, where the dosage period is indefinite, may be
taken daily on a continuing basis(continuous mode) or alternatively, on periodical(sequential) mode wherein the doses are taken for a certain length of time and then stopped for a time. In such an on-ofif arrangement the said on-periods may be fix)m about 2 to 7 months and the off-periods may also be of a similar extent.
vii. The term 'main dose' has been used herein at some places to refer to treatment doses as opposed to the maintenance doses. The terms 'main dose' and 'treatment dose' are. therefore, used interchangeably in this qjecificatioa
viii. Tlie doses may be taken in the form of tablets, capsules, syrups, suspensicms and ix. Some doses comprise the saponin glycosides of caraUuma ^)ecies of plants. Similart>; some
doses include the bitiers of caralluma. These components have been stated to be included in 1^ pregnane glycosides. If the pregnane glycosides in the doses are derived fi*om caialluma it K convenient to extract out said saponin glycosides and the bitto-s as wiell along with it Howewar, said saponin glycosides and bitters may be separate components within the scope of the mventna and added to the pregnane glycosides to form the conqx)sition.
X. Where the component of a dose composition is a plant chemical, the component may be
incorporated in said composition in the form of an extract of the plant or otherwise.
The said uses, methods and compositions and formulations provided by this invention are described
hereinbelow.
1. Obesity:
1.1 For subjects of either gender suffering fix)m clinical obesity with an BMI of atttut 25 to 30, Type
2 diabetes or normal, normotensive or mild to moderate hypertension with no s>'stemic dysfimction, the
subject being preferably on controlled diet and/or moderate physical activit\\ otherwise no restriction.

Main Dose: From about 250 to 500 mg. of caratuberside(CTB) per day over a period of 3 to 4 months followed by an optional maintenance dose of from about 125 to 250 mg. CTB per day for about six to eight months. Said maintenance dose may be taken over an extended period or indefinitely without any adverse effects as caralimna pregnane gjijcosides are good anti-oxidants, non-toxic and v/ell-tolerated nutritional supplements.
1.2 For subjects of either gender suffering fi-om clinical obesity with an BMI of about 30 to 50, Type 2 diabetes or normal, normotensive or mild to moderate nypertension with no sj'Stemic dysfunction, the subject being preferably on controlled diet and/or moderate physical activity, otherwise no restriction, a treatment dose double that provided above for the lower BMI category of subjects and optional maintenance dosage the same as for the lower BMI category is provided, all other parameters including the period for the doses being the same as for the lower BMI categoo'. .
1.3 An alternative sche By about the fifth week, subjects start feeling the lessening of appetite and of the thoughts of food and simultaneously feel more t. ergetic. Appetite is experienced by the subjects at ^jM-opriate times but is satisfied with lesser amounts of food. From this point onwards, weight loss also begins to become quite apparent. By the ninth week, the efiects will be clearly apparmt in w^ght loss, ^petite reduction, reduction of waist, hip and arm circumferenc as and other parameters. The waist circimiference would be down by atleast about 50 nmi(two inches) and the weight by at least 3-4 kgs.
1.4 An alternative treatment for obesity provided by this invention comprises a mixture of PG and
HCA.
Main dose: From about 120 to 240 mg. of CTB with fix>m ^xxtf 150 to 300 mg. of HCA per day over a period of about six months. Optional Maintenance dose: same as the main dose. Period: extended period to indefinitely.

Garcinia extract may be used in place of HCA.
In the case of subjects where the gelatine v^f the capsules causes adverse GI reactions, tlie dose may be
incorporated in a beverage and consumed in the Ik^uid form This applies to all of the treatments
mentioned in this specification. This invention pro\ddes for a number of health-ensuring and nutraceuticaJ
compositions containing PG and other components, the compositions being provided in both solid and
beverage forms.
2. BMR:
2.1 For subjects undergoing moderate phyacal activity and desiring increase in BMR and energy,
endiuance and stamina levels.
Main Dose: From about 250 to 500 mg. of CTB per day over a period of about 3 to 4 months. Optional maintenance dose: From about 125 to 250 mg. CTB per day over an extended period or indefinitely.
2.2 For subjects undertaking heavy physical activi^' such as qwrtspersons and desiring increase in
BMR, energy, endurance and stamina levels:
Main Dose: From about 500 to 1000 mg. CTB per day for a period of about 3 to 4 months. Optional maintenance dose: From about 250 to 500 mg. CTB per day for an extended period or indefinitely.
2.3 An alternative treatment for subjects desiring moderate increase ' BMR, stamina, energy and
endurance levels:
Main Dose: From about 90 to 150 mg, of CTB containing about 2 mg, to 15 mg. of sapomn glycosides of
caralluma together with fi'ora about 100 to 200 mg. of Green tea catechins per day.
Optional maintenance dose: Same as the main dose. Period: extended to indefinite.
'^.4 A yet another course of treatment for subjects desiring increase in BMR, energy, endurance and
stamina:
Main Dose: From about 100 to 200 mg. of CTB containing about 2 mg. to 15 mg. of saponin glycosides of
caralluma logetlier vvitli from about 100 tc 200 mg. of the catechins of green tea an J from about 100 to 200
mg. of the withanolides of Ashwagandha per day.

Period: About 6-9 months.
OpticKial Maintenance dose: Same as the main dose Period : extended to indefinite.
At the end of week two, tlie feeling of fatigue during exercise and workouts comes down and the subject
will feel more energetic and capable of more exercise. At week four, male subjects on exercise
programmes such as weight training will notice an upward trend in bicep ciraumference, chest
circumference and increase in muscle sizes. Female subjects on weight training will see clear signs of loss
of fat surrounding muscle groups. The treatment is suitable for housev/ives whose energy levels tend to
sag after the morning round of work.
3. Lean Body Mass;
3.1 For subjects undertaking moderate physical activity and desiring increase in lean body mass: MaiaDose: From about 250 to 500 mg. CTB per day over a period of about 3 to 4 months followed by an opti(H3al maintenance dose of from about 125 to 250 mg. CTB per day over an extended period or indeficnitely.
3.2 For subjects undertaking heavy physical activity and desiring increase in lean body mass the main dose provided by the invention is from about 500 to 1000 mg. of CTB per day over a period of 3 to 4 months followed by an optiorial maintenance dose of from about 250 to 500 mg, CTB per day over an extended period or indefinitely.
4, Osteo-arthritis:
4.1 For subjects having early to middle stage osteo-arthritis of weight-bearing joints with mild to moderate
radiological s>'mptomatolog} and desiring relief from joint pains and inflammation: Main Dose: From
about 250 to 500 mg. CTB per day over a period of about 4 to 5 months followed by an optional
roamtenance dose of from about 125 to 250 mg. CTB per day over an extended period or indefinitely.
4.2 For subjects suffeixng from severe osteo-arthritis of weight-bearing joints with mild to moderate
radioSogical symptomatology and desiiing relief from joint pains and inflammation:
Main Dose: From about 500 to 1000 mg, CTB per day over a period of about 4 tc 5 months followed by an optional maintenance dose of from about 250 to 500 mg. CTB per day o\'er an extended period or indefiiniteK.

Six alternative courses of treatment for subie:Js suflfering from osteo-arthritis and/or desiring rejuvenation of the weight bearing joints and^or relief froczs joint pains are provided hereinbelow.
4.3 . Main Dose: From about 120 to 3C^ mg. CTB together with from about 400 to 1000 mg. of
Glucosamine sulphate per day for a period c£ about 6 to 8 monflis followed by an optional maintenance
dose same as the main dose for a period of 4.4 Main Dose: From about 90 to 17^ mg. of CTB together with from *out 250 to 750 mg. of
Glucosamine sulphate and from about 75 to 250 rag. of Rutin per day over a period of about 6 to 8 months
followed by an optional maintenance dose same as the main dose for an extended period or indefinitely.
4.5 Main Dose: From about 120 to 3^^ mg. CTB together with from obout 300 to 900 mg. Rutin per day over a period of about 6 to 8 months followed by an optional maintenance dose same as the main dose over an extended period or indefinitely. The maintenance dose may be adopted when the arthritic condition comes under control and the same wsm be taken in two parts, one morning and one evening.
4.6 Main Dose: From about 100 to 20© mg. CTB together with from about 600 to '^50 mg. glucosamine sulphate per day to be taken in two parts. This dose is provided by the invention as a dietary supplement for subjects over forty years of aes and desiiing to prevent the onset of osteo-arthritis by the joints going into a degenerative process. TI)^ dose ensures adequate synovial fluid secretion and rejuvenates the ligaments. In the hereinmencaoned doses the bioflavonoid Rutin may be substituted by one of the other bioflavonoids and the giucosanmae sulphate may be either as the sodium or potassium salt or other. The doses tliat exclude glucosamine sulphate are advised for subjects that have gastric acidity problem as glucosamine sulphate has an acinic reaction in the stomach. Period: Over an extended period or indefinitely.
4.7 Main dose: From about 120 to 300 img. of CTB togetiier with from about 300 to 900 mg. Rutin
and from about 50 to 100 mg. of bamboo siIka(70%Xor equivalent amount of another concentration) per
day over a period of about six to eight monrfis followed by an optional rnainteuunce dose same as the main
dose to be taken o% er an extended period or imdefinitely. The main dose may be stopped and the
maintenance dose adopted as soon as thic artlsditic conditicm is under control.
4.8 Main dose: From about 90 lo 270 m^. of CTB together^** from about 250 to 750 mg. of
Glucosamine sulphate, from about "5 to 250 mg. of Rufin awi from about 50 to 100 mg. of

Bamboo silica(70%)( or equivalent amount of another conceifiration) per day over a period of about six to eight months followed by an optional maintenance dose same as the nsain dose for a period of about six months or indefinitely. The pregnane glycosides in the abovementioned doses for osteo-arthritis provide Ae anti-iaAamraatoiy action and regenemtive actioa This is important as both glucosamine sulphate and diondm^in do not possess anti-inflammation properties. The subjects may be on NSAID th^^apy andk>r physaotherapy treatment. Caralluma extracts are well-tolerated and exhibit no side effects on i^dcmged coBsumption. Preferably tlie doses may be taken after the meals.
At week three, gradual alleviation of pain occurs togetho* with an increase in jcnnt mobilitv as^ inaeased tolerance to physical stress. At week five, the subjects esqwriencc near-nonnaicy in joint nKJvements and cessation of pain, significant reduction in morning stifiOsess, increased toleianoe to exercise ^md quicker recovery from exercise. At week 13, fiuther bone degradation ceases almo^ iotaOy as estafaiished by radiological investigations.
Where a)mbination main doses have been provided, the same may be disccHitmued when Ac arthritic
condition comes under ccntroL From that point, a maixtfenance dose of from ^x« 250 tc 300 mg. of CTB
per day may be adopted for a period of six to eight months. The said maintenance dose isay be
preferably taken in two stages after the two main meals of the day. For severe cases, the combination
doses may preferably be continued indefinitely.
5; Blood Sugar:
5.1 The treatment provided by this invention for subjects having Type 2 diabetes and FBS(Fasting
Blood Sugar) of about 120-150 mg./dL
Main Dose: From about 500 to 1000 mg. CTB per day Period: prolonged to indefiniie
5.2 For subjects having Type 2 diabetes and FBS exceeding about 150 nagydL
Main Dose: From about lOCO tol500 mg. CTB per day ovK" a pn)longed period «■ indefiniftdy. The following two alternative courses of treatment are provided by the invention.
5.3 For subjects having Type 2 diabetes and/or desiringccmtrolAtgDlatioo of Uood sngar

Main Dose: From about 100 to 250 nig. CfB together witirfrom about 100 to 200 mg. of 4-hydroxy-iso-Ieucine(cr as Fenugreek extract) per day, the PG containing about 2-3% bitters of the caralluma species of plants. Period: 6 to 8 months.
Optional maintenance dose same as the main dose. Period: over an extended period or indefinitely. 5.4 For subjects having Type 2 diabetes.
Main Dose: From about 100 to 200 mg. of CTB together with from about 100 to 200 mg. of Coccinia extract containing about 10% terpenes, from about 100 to 200 mg. of Bitter gourd extract containing about 8% bitters, from about 100 to 200 mg. of Cmnamon extract containing ;dx)ut 15% polyphenols and from about 100 to 200 mj. Fenugreek extract containing about 40% 4-hydroxy-iso-leucine per day for a period of about 6-7 months followed by an optional maintenance dose, same ^ the main dose, preferably for an indefinite period.
Preferably the doses are token 30 mia after meals. The dose may be Isten in one stage or in two. At week two the subject would e>q)erience a reduction of about 10% in FBS and FPBS(Post-prandial blood sugar). At week four onwards, weight loss will be observed and also increased {di>'sical stamina. Blood sugar lev^els drop further. About 20% reduction in FBS and PPBS can be eq>ected at this period. At \»'eek 16, reduction in glycosylated haemoglobin will be observed. Subjects m^ stop their main dose after the stipulated period for a period of about 6-8 months. Tliey niay then revive the main dose for about 2-3 months after a gap of about 2-3 months. This sequence may be continued indefinitely. For subjects over forty years of age, it is preferable that the said sequence is continued indefinitely. For subjects over fifty, preferably the main dose should be continued indefinitely. Regular exercise in the form of a hn^ walk of 45 min. morning and evening is advised and it is suggested that suigects avoid refined carbohydrate foods.
G. Blfi^d Pressure:
6,1 For subjects buffering from mild to moderate hyp^tcosion the main dose provided by the invention comprises from about 250 to 500 mg. of CTB pra day to be t^en over a period of about 3 to 4 months followed by an optional maintenance dose of from shout 125 to 250 mg. of CTB per day for an extended period or indefinitely.

6.2 For subjects having se\^^ h>-pertension the treatment provided by the invention comprises: Main Dose: From about 500 to 1000 mg. of CTB per day for a period of about 3 to 4 months followed by a maintenance dose of from abom 250 to 500 mg. of CTB per day for an extended period or indefinitely.
6.3 An alterriam^e course ^ provided by the invention for subjects having mild to moderate hypertension wherein the main dose is from about 125 to 250 mg. of CTB together with from about 125 to 250 mg. of HCA(Garcinia extract) per day to be taken over an mdefinite period.
6.4 A still another ahemath=€ course of treatment and management for this condition provided by the invention comprises a main dose of from about 125 to 250 mg. of CTB together with from about 125 to 250 mg. of Commiphora Mukul extract containing about 3% gugulsxrones per day to be taken over an indefinite period.
The tests have established that csegnane glycoside(s) reduce blood pressure, both systolic and diastolic.
Another related effect is that of reducing serum LDL(Low density lip(5m)tein) and enhancing the HDL
(High density lipoprotein). The dose may be taken in one stage or two and is preferably taken after n^s.
At week three, increased aierg\- and exercise endm'ance were obsen^ Tlds brings down the L DL levels.
Physical traimng is advised durii^ the treatraeni. At week five, mcrease in the HDL level and further
increases in energy and endurance are observed.
7j Appetite Reduction:
7.1 For subjects tfesiring miid to moderate reduction ia appetite, this invention provides: Main Dose: from about 250 to 500 mg. of CTB per day over a prolonged period or indefinitely.
7.2 For subjects desiring he2\y reduction in appetite: Main Dose: From about 500 to 1000 mg. of CTB per da>^ o^er a prolonged period or indefinitely.
7.3 This invention provides an alternative course comprismg pregoane glycosides and HCA. Main dose: From about 120 to 240 rag of CTB with from ah ut 150 to 300 mg. of HCA per day over a period of about six months. Optional Maintenance dose: same as the main dose. Period: extended period to indefinitely.
Garcinia extract ma> be used in piace of HCA.
8; Weight redQCtion:
8.1 For subjects desiring slcr^'^/gradual reduction in weight: Main Dose: From about 250 to 500 mg. of

CTB per day over a period of about 3 to 4 months followed by an opttonai mmtenance dose of from about 125 to 250 mg. CTB per day taken over an extended period or indefinitely.
8.2 For subjects desiring rapid reduction in weight Main Dose: From about 500 to 1000 mg. CTB per 4ay over a period of about 3 to 4 montlis followed b}' an oi^oaal maintenance dose of from about 250 to 500 mg. CTB per day over an extended period or indefinitely-
8.3 This invention provides an alternative course comprising pregnane dv^cosides and HCA. Main dose: From about 120 to 240 mg. of CTB with from about 150 to 300 mg. of HCA per day over a period of about six months. Optional Maintenance dose: same as the main dose. Period: extended period to indefinitely.
Garcinia extract may be used in place of HCA.
9j Waists arm and hip circumference:
9.1 For subjects desiring reduction in waist, hip and arm ctrcumfereaoss: Main Dose: From about 250 to 500 mg. of CTB per day over a period of about 3 to 4 mon^ Miowed by an optional maintenance dose of from about 125 to 250 mg. CTB per day over an extended period or inckfisitefy.
9.2 This invention pro\ides an alternative course comprising pregnane ^cosides and HCA. Main dose' From about 120 to 240 mg. of CTB with from about 150 to 300 mg. ofHCA per day over a period of about six months. Optional Maintenance dose: same as the main dose. Pedod: extended period to indefinitely.
Garcinia extract may be used in place ofHCA.
10, Migraine:
10.1 For a subject desiring relief from migraine: Main Dose: Fran aboA 500 to 1000 mg. of CTB per
day over a period of about 3 to 4 months, said dose to be doited daring the periods of attack.
The daily dose may be preferably taken in two parts om aft^ c&i meal. At week five, the subject will
notice decreased frequency of attacks. The pregnane glycosides exats its aai-inCammatory pioperties
and also restores elasticity to the capillaries. The and-depressant propeity of pregnane glycosides gives a
psychological boost to the subject. His confidence level increases due to tDcreased secretion of serotonin.

At week nine, the subject experiences significantiy reduced frequency of attacks and increased tolerance to physical stress. At week tliirteen, the ft^uency of attacks can be expected- to be down to less than 10%L A maintenance dose of from about 125 to 250 mg. of CTB per day may preferably be continued indefinitely.
11. Clinical depression:
11.1 For a subject suffering fix)m mild clinical depression: Main Dose: From about 125 to 250 mg. of CTB per day to be taken till the ceasing of the symptoms.
11.2 For subjects suffering from severe clinical depression: Main Dose: From about 250 to 1000 mg. CTB per day to be taken till the ceasing of the symptoms.
11.3 An alternative course provided by the invention for a subject suffering from clinical depression or desiring mood elevation comprises a main dose of from about 250 to 500 mg. CTB per day together with from about 100 to 200 mg. of the withanolides of Ashwagandha over a pmod of about 12 to 18 monihs followed by an optional maintenance dose of from about 125 to 250 mg. of CTB per day together with from about 50 to 100 mg. of the wit^3nolides of Ashwagandha over an extended pOTod or indefinitdy. Depressions aie associated with abnormal levels of serotonin reuptake. Pregnane glycosides cause increase in serotonin le\'els without the adverse effects such as serotonin intoxication of known antidepressants such as the SSRI's With pregnane glycosides, subjects experience increased feeling of weU-being, increased energ}' levels, increase tolerance lo stress and a general improvement in mood infer alia through its effect on serotonin levels. Adverse effects, if any, are of a milder form than with said SSRI's. Tlie subjects begin to experience increased energy levels, reduced fatigue and tiredness and general well-being at week three. At week four, there is ftuther all-roimd improvement in the abovementioned parameters and tiie subjects experience increased social interests.
12. Sexual dysfunction;
12.1 For a subject suffering from primary impotence and/or decreased libido and/or desiring increased libido and sexual drive, power and stamina: Main Dose: From about 500 to 1000 mg. of CTB per day ov-er the period of existence of dysfunction and decreased libido or as desired by the subject.
12.2 An altemati\ e course provided by the invention for a subject suffering from sexual d\'sfunction such as primar>' impotenc}' and/or reduced iibido or desiring increased sex drive, power and stamina: \iain

Dose: From about 250 to 500 mg. of CTB per day together with fiom about 100 to 200 mg. of the withanoUdes of Ashwagandha over a period of about 6 to 12 mcmths followed by an optional maintenance dose of from about 125 to 250 mg. of CTB per day togetlier with from ab' or as long as increase in sex p6wer is desired,
12.3 A yet another alternative course provided by the invention for a subject suffering from sexual
dysfimction such as primary impotence and/or loss of, or reduced hbido and/or desiring increased sex
power, stamina and drive comprises:
Main Dose: From about 250 to 500 mg. of CTB per day together with fijom about 100 to 200 mg. of Shilajith over a period of about 6 to 12 months followed by an optional maintenance dose of about 125-250 mg. CTB per day together with about 50-100 mg. of Shilajith for as long as necessary or as long as increased sex drive is desired.
12.4 A yet another course of treatment provided by the inventioa for a subject suffering from sexual
dysfrinction such as primary impotence ai^or loss of, or reduced libido and/or desiring increased sex
power/drive and stamina Main dose; From about 250 to 500 mg. of CTB per d^ together with fiom
about 250-500 mg. of Fenugreek extract cuntaining abou^ SOVo Protodioscin to be taken over a period of
about 3-4 months followed by an optional maintenance dcse of fijom about 125 to 250 mg. of CTB together
with from about 125 to 250 mg. of said fenugreek extract per day for as l(mg as necessary or as long as
increased sex drive is desired.
The effects of pregnant 'hcosides relevant to its application in treatment of sexual dysfunction are: increase in energy, endurance and stamina, beneficial effect on capillaries and through that on circulation, feeling of increased well-being, increased tolerance to stress, elevation of mood and others. Together these effects appear to produce increased blood flow in the region of the reproductive organs and cause resurgence of sexual interest and increase of libido which has been clearly established by the testS/'trials. Caralluma extract? also appear to be beneficial for women in the post-menopausal phase when they experience reduced sexual desire, painfiil intercourse, diminished sexual responsiveness, difficulty in achieving orgasm and decreased genital sensation. Pregnane glycosides do not have the caidio-vascular and other side effects exhibited by the known compounds for treatm^u of sexual ^sfimction, such as, for example, tlie FDE5 inliibitors.

13. Cognitive and memory function;
13.1 For a subject suffering from diminished cognitive and memory fimction or desiring increase thereof: Main Dose: From about 250 to 500 mg. of CTB per day over a period of about 3 to 4 months. Caralluma extracts have a beneficial effect on neurotransmitter levels and functioning and, in particular, on serotonin levels. It aiq)ears that the multiple effects of {Hcgnane glycosides on a subject lias a cascade type effect causing an all-round improvement in body flmctions including cognitive and memory function, memory recall and retention and speed of retrie\'al. This has been established by said tests/trials. The dose may be taken JX a single stage or two and is preferably taken after meals.
14. Aging svndnmie:
14.1 For subjects desiring treatment/management of the aging syndrome, this invention provides for a main dose of from about 250 to 500 mg. of CTB per d^ over a proloi^ed to indefinite period,
14.2 An alternative course provided by the invention ccHnprises a dose of from about 100-200 mg. of CTB per day together with fix)in about 100 to 200 mg. of tte catechins of green tea and from about 100 to 200 mg. of the saponin glycosides of caralluma followed by an opticmal niaintenance dose of fix)i;i about 100 to 200 mg. of CTB per day together with from about 50 to 100 mg. of said catechins and from about 120 to 300 mg. of said saponin glycosides over an indefinite period.
14.3 Tiiis invention also provides a dietary supplement for fighting the aging ^ndrome comprising a dose of from about 100 to 200 mg. of CTB per day together with from about 250 to 350 mg. oi 'jreen Tea extract containing about 40% catechins to be taken indefinitely.
14.4 A yet another composition provided by this invention for a subject desiring reduction in the aging syndrome comprises a main dose of from about 50 to 100 mg. of CTB per day together with from about 100 to 150 ng. of Zinc monoraethionine, from about 150 to 250 mg. of Citrus bioflavonoids and selenium chelate equivalent tc t^ota about 2 to 8mg. of selenium to he taken over an indefinite period.
The properties of pregnane glycosides relevant to its appUcation as an anti-oxidant and in combating aging
are: i. Reduction of fat ii. Increase of energ>' levels and stamina levels iii. Increased physical acti\it>
iv. lowered stress ard mood elevation v. increased joint mobility vi. increasing capillary elasticity-
and others. These benefits are obtained with substantially nil side effects.

15., Loss of Hearing;
15.1 For a subject suffering from hearing loss: Main Dose: From about 250 to 500 mg. of CTB per day ovsr a period of about 3 to 4 months followed by an optional maint^iance &)se of from about 125 to 250 mg. of CTB per day taken over an extended period or indefinitely. 16. Circulation disorder
16. i For a subject suffering from a circulation disorder: Main Dose: From about 500 to 1000 mg. of CTB per day over a period of about 3 to 4 months followed by an optional maintoiance dose of from about 250 to 500 mg. per day of CTB over an indefinite period. The invention provides for the maintenance dose to be taken indefinitely in case of severe circulation disorder and where the disorder is mild and tlie maintenance dose is not adopted then the main dose should be ccmraienced upon reoccurrence of the disorder/symptom. The main dose must be revived if the ciroilation problem reoccurs and in cases of severe circulation problems the main dose should preferal^ be continued indefinitely. 17> Capillary Degeneration:
17- IFor a subject desiring restoration or maintenance of capillary elasticity: Main Dose: From about 500 to 1000 mg. of CTB per day for a period of about 3 to 4 months followed by a maintenance dose of from about 250 to 500 mg of CTB per day to be taken over an indefirute period It has been observed that caralluma extracts enhance/restore capillary elasticity. Together with the other effects of pregnane glycosides, die subject experiences an all-round improvonent of body functions inchjiding hearing, sexual function, skin health, mental functions, circulation and othas. The dosage may be uaken in one stage or two and is preferably taken in two stages after the two main meals of the day.
18. Skin Nourishment;
IS. 1 For a subject desii:ing skin nourishment and skm elasticity and health: Main Dose: From about 50 to 100 mg. of CTB per day tog^iher with from about 100 to 150 mg. of Zinc monomethionine. from about 150 to 250 mg. of Citms bioflavonoids and from about 2 to 8 mg. of selenium as selenium chelate or other compound, to be taken over an extended period or indefinitely.
19. Menopausal syndrome:

19.1 For a subject suflering from the menopausal syndrome and desiring alleviatioii from hot flushes
and menopausal distress: Main Dose: From about 50 to 100 mg. of CTB per day together with from
about 100 to 150 mg. of Zinc monomethionine, from about 150 to 200 mg. of Citros bioflavonoids and
from about 6 to 10 mg. of selenium as sdenium chelate or odio" compound to be taken as long as
necessary.
Four flirther courses of treatment and management for a subject sufTering from menc^usal syndrome are indicated hereinbelow.
19.2 Main dose: From about 50 to 100 mg, of CTB together with from about 100-200 mg. Liquorice
extract containing about 5% Triphytoestrogens per day to be taken as long as necessary and as long as
symptoms last,
19.3 Main dose: From about 50 to 100 mg. of CTB together with frmn about 100 to 200 mg. of Red
clover extract containing about 8% isoflavones per day to be taken for as long as necessary and as long as
symptoms last 19.4 Main Dose: From about 50 to 100 mg. of GIB together wih from about 100
to 200 mg, of Hops flower extract containing about 5% triph>toestrogens per d^ to be taken for as long as
necessary and as long as symptoms last
19.5 Main dose: From about 50 to 100 mg. of CTB togetha: with frmn about 100 fio 200 mg. of Pomegranate extract containing about 10% EUagic acid per day. Period: As long as the symptoms and as long as necessary'.
20. Cancer prevention/protection;
20.1 For a subject desiring the neutralisation of carcinogens and jHotection against caacer: Main Dose: From about 50 to 100 mg. of CTB per day together with from about 100 to 150 mg. of Zinc monomethionine, from about 150 to 200 mg. of Citrus bioflavonoids and from about 2 lo 8 mg. of selenium, as selenium chelate or other compoimd to be taken indefinitely.
21. Cholesterol:
21.1 For a subject desiring reduction of total blood cholesterol: Maiu Dose: From about 125 to 500 rag. of CTB per day together with from about 150 to 250 mg. of Elibiscus Subdaiife extract containing about 25% polyphenols and from about 100 to 200 mg. of Commiphora Mukul es&act containing about 3% gugulsterones to be taken for an indefinite period.

21.2 An alternative composition jM-ovided by the invention for a subject desinng reduction in blood cholesterol: Main Dose: From about 120 to 240 mg. of CTB per day together with from about 150 to 300 mg. of HCA over a period of about six months followed by an optional maintenance dose same as the main dose over an extended poriod or indefinitely preferably over an indefinite period.
21.3 A yet another alternative composition provided by the invention for a subject desiring reduction in blood cholesterol: Main Dose: From about 90 to 150 mg. of CTB containmg about 2-10% saponin glycosides, together wiJi from about 100 to 200 mg. of the calechins of green tea per day over an extended period or indefinitely.
22. BMI:
For a subject desirous of reducing BMI, the invention provides for the following courses of treatment and
management
22.1 For subjects of either gender having a BMI of about 25 to 30, Type 2 diabetes or normal,
normotensive or mild to moderate hypertension widi no systemic dys&mction, the adjject being preferabty
on controlled diet and/or moderate physical activity, otherwise no restrictioa
Main Dose: From about 250 to 500 mg. of caratuberside(CTB) per day over a period of 3 to 4 months followed by an optional maintenance dose of from about 125 to 250 mg. CTB p^ day for about six to eight months. Said maintenance dose may be taken over an extended period or indefinitely without any adverse effects as caralluma pregnane glycosides are good anti-oxidants, non-toxic and well-tolerated nutritional supplements.
22.2 For subjects of either gender having a BMI of about 30 to 50, Type 2 diabetes or normal, normotensive or mild to moderate hypertension with no systemic dysfunction, the subject being preferably on controliec' diet and/cr moderate physical activity, othowise no restriction, a treatment dose double that provided above for the lower BMI category of subjects and optional maintenance dosage the same as for the lower BMI category is provided, all other parameters including the period for the doses being the same as for the lower BMI category. .
22.3 An alternative schedule for the maintenance dose is to take the same for a period of about 4-5 months and then stop the same for a period of about 6 months. The maintenance dose may be again started at the end of the said 6 month period and continued for about three months. The maintenance

course maj^ be continued under this sequence of sL\ and three months for an indefinite period. The water
intake should be double of the normal during the treatment. During the treatment one-half hour brisk
walks morning and evening and diet control are advised.
By about the fifili week, subjects start feeling the lessening-of appetite and of the thoughts of food and
simultaneously feel more energetic. Appetite is experienced by the subjects at appropriate times but is
satisfied with lesser amounts of food. From this point onwards, lowering of the BMI{weight loss) also
begins to become quite apparent.
22.4 An alternative composition of this invention for increase of BMI comprises: Main dose: From
about 120 to 240 mg. of CTB with from 150 to 300 mg. of HCA per day over a period of about six months.
Optional Maintenance dose: same as the main dose. Period: extended period to indefinitely.
Garcinia extract may be used in place of HCA.
23. Anti-oxidation;
23.1 This invention provides for an anti-oxidation course ibr siAjects desiring treatment/ management of the aging syndrome and/or for general fitness and health, comprising a main dose of from from about 250 to 500 mg. of CTB per day over a prolonged to indefinite period.
23.2 An alternative anti-oxidation course provided by the invention comprises a dose of from about 100 to 200 m.g. of CTB per day together with from aoout 100 to 200 mg. of the catechins of green tea and from about 100 to 200 mg. of the saponin glycosides of caralluma followed by an optional maintenance dose of from about 100 to 200 mg. of CTT per day together ^\ith fix)m about 50 to 100 mg. of said catechins and from about 120 to 300 mg. of said Si^ponin glycosides over an indefinite period.
23.3 This invention also provides an anti-oxidant dietar>' supplement for fighting the aging syndrome and/or provide general health and fitness comprising a dose of fix)m about 100 to 200 mg. of CTB per day together with from about 250 to 350 mg. of Green Tea extract containing about 40% catechins to be taken indefinitely.
23.4 A yet another composition course provided by this invention for a subject desiring reduction in the aging syndrome and/or ensuring general health and fitness contprises a main dose of fix)m about 50 to 100 mg. of CTB per day together with fix)m about 100 to 150 n^. of Zinc rocHiomethionine, fixnn Bboui 150 to

250 mg. of Citrus biofiavonoids and selenium.chelate equivalent to from about 2 to 8 mg. of selenium to be taken over an indefinite period.
The properties of pregnane glycosides relevant to its a|q>lication as an anti-oxidant and in combating aging are: i. Reduction of fat ii. Increase of eneis^ levels and stamina levels iii. Increased physical acti\it}' iv. lowered stress and mood elevation and v. increased joint mobility vi. improved circulation and otliers. These benefits are (Stained with substantially nil side effects.
In all the treatments described hereinabove, the dosages may be taken before, during or after meals. However, where the objective is to provide relief fi*om one or more of the obesit>-related symptoms the dosages may be preferably taken one-half to one hour before meals. A daily dose may be taken at one time or in two stages. If taken at one time, it may be prrferably taken before, during or after the main meal of the day.
The term 'indefinitely' used in relation to said treatment and maintenance doses is intended to mean that ' the doses are to be taken substantially lifelong in a contiiaious mode wherein the doses are taken daily without a break. The scope of the said term indefinitely' is intended to include the option of taking the maintenance doses in a periodical(sequential) anangemeiit(mode) comprising taking the doses periodically over periods of about two to seven months with the gaps also extending to about two to seven months. In the applications related to (*esity-related symptoms, the sequential formula for maintenance doses described hereinabove is recommended.
Various embodiments and variations other than described hereinabove that are wi Jiin the art are within the scope of the inventioa





We claim;
i. A phamiaceuticai composiliou for use iu the treamient and management of one/or more
symptoms/disorders such as obesil>\ migraine, osteo-arthritis, overweight, clinical cljpvession, hearing loss. >Qx\n\] dysfui>ciioii. liigli BMI, low BMR, hyperglycaeraia. hypertension, hypercholesterolemia, low stamina, endurance and energ>' levels, reduced cognitive and memory functions, capillary degeneration, joiia inflammation/degeneration, menopausal syndrome, aging syndrome, circulation s>^ndrome and others:, in Oie alteration/unprovement'regulation of one or more parameters/condition&' functions such as appetite levels, weight, BMI, BMR, waist, arm and hip circumferences, fat levels, lean body mass, blood sugar, blood pressure(bp), total blood cholesterol, Wood HDL to LDL ratio, stamuia, energ} and endurance levels, cognitive and memory function, mood, circulation, capillary healtli. heanng, aging, joint mobilit>, sexual power, drive, stamina and libido, and/or others; and in skin nourisl-iinent and as an and-oxidant, anti-infiammation and anti-depressant agent, the first componeut thereof comprising pregnai>e glycoside(s){PG) in the fonn of extracts of the caralluma species of plaiUs or oUtenvise, eitlier singly or as mixtures thereof, and fiirther comprising one or more additional tlierapeutic^l, nutraceutiail or nutritional components, namely, second, third and higher order components, said tre^ntmcnt and management and aiteration/iraprovement/regulation comprising the admijiistration of an effective daily treatmentCmain) dose(s) thereof to the subject over an adequate period of time followed optionally by a daily maintenance dose(s) tliereof to be taken oplioi;aUy m a continuous cr periodical(sequentiai) mode over an extended period of time or indefinitely, the said pregnane glycoside(s) optionally including ilie saponin glycoside(s) and/or the bilters of said caralluma species and the said PG content of said main and maintenance doses being S|X"cifred by the luolecularly equivalent amount of caratuberside(CTB) iherein.

It

A piiannaccutical composiTiori as claimed in the preceding claim L for use as a treatment dose and/'cr a njaiiiieriancc do6-'z in:
\. it--: r.riierV'mr'magement of obesity;
u. reduciiig aDDetiie levels;
ri reducing waisi. ;:rm and hip circumferences:
u. \vei£^ht-ri:duction;
\. icd'jciion of blood choleslerol; and
M, rcaucticn of BIviL
of a subject, coinpnsmg uxsi arid second components, said first comprising any of tlte pregnane L'hcoeides. o: >ih\iu:cs t:r_^recr. ?jid the said second comprising (-)-hydro\Tcitralc(HCA)(iR the forv.x oi Garcinia cambogia cxtnic! or ouier^visc), tlie amoimt of said first beuig lo the extent of from about four 10 ciglit pans b> ^veighi while thai of said second bt:u;g lo the extent of from about five to ten

parts by wt., the mnouut of said first being specified itercin in terms of the molecularly couivalent amomit of the pregnane glycoside, caratubersidc.
3. A phannacculical composition as claimed in tlie precedmg claim I. for use as a treatment dose and/or a
maintenance dose in:
i. trealment/management of th.e aging syndrome:
il skin ncnrislmient and maintaining skin elasticity^ and health;
iii. protection fi^om and pre\ention of cancer: and
iv. antioxidant action and ensuring general health and fitiicss,
of a subject, comprising fu-st second, tliird and fourth components, said first comprising any of the pregnane glycosides, or mixtures thereof, said second comprising Zinc monomethionine, said third comprising Citats bioflavonoids dnd said fourth comprising seleBium(as chelate or in another fomi), the amojnt of said first being to tlie extent of ft'om about 25 to 50 parts by weight, of said second from about 50 to 75 parts by wt., of said third from about 75 XQ 125 parts by wt. and of said fourth from about one to four pans by wt., tlie amount of sa'd first being specified herein in terms of the molecularly equivalent amount of tlie pregnane gi>coside, caiatuberside.
4. A phaiinaceuticai composition as claimed in the preceding claim 1, for use as a treatment dose and/or a
maintenance dose in the treatment of i subject suffering from the menopausal s>ndi"ome and/or
desiring alleviation from hot flushes and menopausal distiess, comprising first second, tliird and fourfh
components, said first comprising ain of the pi rgnane glycosides, or mixtures thereof, said second
comprising Zinc mor.ometliioninc, sa^d third comprising Citnis biollavonoids and said fourth
comprising selemuni(as chelate or in another form), the amount of said first being to the extent of from
:;boul 2 5 to 50 parts by weight, c' ^aid second ft'om about 50 lo 75 parts by w1., of said tliird from
about 75 to 100 p^ns by wt. and o: aid foiuth froiii about tliree (o fi\c parts by wi., tlie amoimt of said
firsl being sp^jcifled herein m lerms of the iriolecuiaiiy eqni^.'^lent amount of the pregnane glycoside,
caialubersiuc.
\ A pharmaceutical composuion as claimed h\ the preceding claim 1. for use as a treatment dose and/'oi a mamt^jr.ance dose in the Uearncnt of a subject desmng a moderate irtcrease in BMR and/or in stainiiu' eudtirancc and energy le\ el:, ccmprisinr^ nr^t and second components, said first comprising a.*n ofihe pregnatic _^?j;/co'iidc >. or Tu;vn,Ln;s tl.cicofand including diccintlie saponin glycosides of the caialhiijia species of plants, aud ti;e s to one hundred parts by wi. and of said saponin glycosides being to the extent from about one to sc\en and half parts by wt., the amount of

said first being specified herein in tcnns o! the molecularly equivalent amount of the pregniuic glycoside, caratubersidc.
6. A pharmaceutical composition as claimed m the preceding claim 1, for use as a treatment dose and/or a mainienaiice dose in the treatment of a subject desiring an increase in BMR and/or in stamiita., endunmce and energy levels, comprising first, second and tlurd components, said first comprising am of the pregnane glycosides, or mixtures thereof and including dierein the saponin glycosides of the cardllmna species of plants, said second comprising the catecliins of Green tea(as Green tea extract or otherwise) and said tliird comprising witlianolides of Ashwagandha(in tlie fonn of Withania somnifera extract or otliennse). the amount of said first, second and third each being to the extent of from about 50 to 100 parts b}^ wt., and of said saponin glycosides being to the extent from about one to ten parts by v\l., the amount of said first being specified herein in terms of the molecularly equivalent amount of the pregnane glycoside, caratubersidc.
7. A pharmaceutical composition as claimed in the preceding claim 1, for use as a treatment dose and/or a maintenance dose in the treatment of a subject suffering from osteo-arthritis of weight-bearing joints and/or desiring relief from joint pains and hiflammation comprises first, second and third components, said first comprising any of the pregnane ^ycosides, or mixtures thereof, said second comprising Glucosaniine(as sulphate or otherwise), and said tliird comprising Rutin(or other biofla\'onoid), the amount of said first being to the exient of from about 45 to 135 parts by wt., of said second being lo th'c extent of fi"ora about 125 to 375 paris by \\i. and of said third being to the extent of fi"om about 35 <:o parts by wt. the amount of said first l specified herein in terms molecularh- equivalent pregnane glycoside caratubersidc and glucosamine being as sulpliatc salt thereof> 8. A pharmaceutical composition as cL^imed m the preceding claim 1, for use as a j'eatment dose aiid^or a maintenance dose in the treatment of a subject siuTering from osteo-artltritis of weight-bearing joints andA:)r desiring relief from joint pains and inflammation comprises first and second compcnenis. said first comprising any of tlie pregnane glycosides, or mixmres tiierecf and said second compnsin . Ruiinrfor otlier biofla\'onoid), tlie amount of said first bemg to the extent of fironi about 4 to 10 parts b> wi. ■' d of said second t-emg to the extent of from aboi't 10 to 30 parts by v.t., the amouxu of said firsi bcuv^ specified herein hi terms of the niclecuiarh- equivalent amount of die pregnane glycoside. caraiuberside.
9. A pliannaceutical composition and dietaiy supplem.ent as claimed in the preceding claim 1. for use as a treaunent dose and/or a maintenance dose in the treatment of a subject suffering from csteo-artluius of weight-bearing joints and'ordesiring/eiief from joint |:)ains and inJhunmation and the rcjinenation

of the joints compnses first and second components, said first comprising any of the pregnaiic gIycoside>N. or niixtures tliereof, said second comprising Glucosamine(as sulphate or otherwise), the amount of said first ^ocmg to tlie extent of from about one to two parts by wt. and of said second being to tlie extent of from about 6 to 7.5 parts by wt.. thie amount of said first being specified herein in terms of the moiecularly eciii\'alent amount of the pregnane glycoside, caratuberside and the said glucosaniine amount specified herein being as the sulphate salt tliereof
A pharmaceutical composiuon as claimed in the preceding claim 1, for use as a treatment dose and/or a maintenance dose in ihc treatment of a subject suffering from osteo-arthritis of weiglit-bearing joints and/or desiring relief from joint pains and inflammation comprises first, second and third components, said first comprising sny of the pregriane glycosides, or mixtures thereof, said second comprising Rutin(or oilier biofla%'onoid) and said tliird comprising Bamboo Silica(of 70% concentration or other), the amount of said first being to Liie extent of from about 12 to 30 parts by wt., of said second being to tlie extent of from aboat 30 to 90 parts by wt. and of said third being to the extent of from about "> to 10 parts by wi.. the amotint of said first being specified herein in terms of the moiecularly equivalent amount of tlie pregnaBe glycoside, caramberside
A pharmaceutical composition as claimed m the preceding claim 1, for use as a treatment dose and/or a matntenaiice dose in the treatment of a subject suffering from osteo-arthritis of weight-bearing joints and/'or desiring relief from joint pains and h iflammation comprises first, second third and fourtli components, said tlrsj comprising any of tlie pregnane glycosides, or mixtures thereof, said second comprising Glucosa3iiu":e(as sulphate or otherwise), said thira comprising Rutin(or otlier bioflavonoid) and said fourth comprising Bamboo SiIica(of 70% concentration or otlier), the amount of said first being to the extent of from about 9 to 27 parts by wt.. of said second being to the extent of from about 25 to 75 p-irts b> wi :f said third being to llie extent of from about 7.5 to 25 parts by wt., and of said fourth bcirg !o tlie ex^int of from about 5 to 10 psns hy wt., tiie amount of said first being specified herein m lenns ?f the -iiokcuiarlN' equivalent amount of the pregnane glycoside, caratuberside m\d tlie said glucosainiae amo mi specified herein being as the sulphate salt theieof
A pharmav-eiiticai con:p=DSiDon as claimed in die preceding claim 1, for use as a treatment dose and/or a maintenanwc dose m '^c treamient of a subject suffer ■"- from ele\'ated blood sugar le\-cls or T^pc 2 diabetes -tiid^or desire:ii concrol/re,eiilation of bU-)od sug T comprises first and second components, said first coHipniiing an> :: liie pregnane gl> cnsides. or mixtures thereof and including oierein the bitters of tiie caralb-ina species :: plants, and said second comprising 4-hydrox>-iso-lcucuie(as Fenugreek extracl or otherwise). :he amount of said first being to the extent of from about 100 to 250 parts by wt and of said secoiid being to tlie extent ot from about 10(» to 200 parts by wt., the amounts of said bitters

being to the extent of from about 2 to 8 parts by \vt. and tlie amount of said first being specified herein in tenns of the raolecularly equivalent amount of tlie pregnane glycoside, caratuberside.
^. A pharmaceutical composition asxlaimed in the preceding claim 1, fc; use as a treatment dose amd/or a maintenance dose in the treatment of a subject suffering from elex'ated blood sugar levels or T>pe 2 diabetes and/or desiring control/regulation of blood sugar comprises first, second, third, fourth aiid fifth components, said first comprising any of the pregnane glycosides, or imxtures thereof, said second comprising Coccinia extract containing aboout 10% terpenes, said third comprising Bitter gourd extract containing about 8% bitters tliereof, said fourth comprising Cinnamon exHact containing about 15% polyphenols thereof and said fifth comprising Fenugreek exUact containing about 40^0 4-hydrox>'-iso-leucine, the amount of said first being to the extent of from about 100 to 250 parts b\' v^t and of said second, third, fourth and fifth each being to tlie extent of fix)m about 100 to 200 paits by \^t., the amount of said first being specified herein in terms of the molecularly equi\-aient amount of the pregnane glycoside, caratuberside.
L A pharmaceutical composition as claimed in the preceding claim 1, for use as a treatment dose and/or a maintenance dose in the treatment of a subjea having mild to moderate hypertension, comprising first and second components, said first comprising an}- of the pregnane glycosides, or mixnir^ thereof and the said second comprising Commiphora mukul extract cx)ntaining about 3% gngulsterones, ih^ amount of both said first and second components each being to the extent of from about 125 lo 250 parts by ^AI., the amount of said first being specified herein in tc^}^s ci the molecularly eqmvale^i amount of tlie pregnane glycoside, caratuberside
i. A phannaceuiical composition as claimed ui t)i'^ preceding claim i, for use as a treatment, dose ;£nd/or a ■ a-iiintcnauce dose in tlie treatment of a subject suifering from ciiniail depre;5sion or desiring iP.X'd ele>'ation, compnsing first and second components, said first comprising any of tlie pre.gn^iie glycosides or mixtures thereof, and tiie said second comprising the Avithanohdes of Ash^vagaildil3(il? the extract of Withania somnifera or otherwise), the amount of said fi.rst being to the exiei^t of &Gni about 10 to 25 parts by \\t. and that of said second bemg (o the extent of from about 4 to 8 psjts b} ^vt. the .unount of said first being specified herein hi terms of the molecularly equivalent amount or' ihc prcgiiiiiie ghcoside, caratuberside.
. A phainiiiceattcai composition as claimed in the preceding claim (., tor use as a iieatmeni dose .iTidcr a inaiiiienance dose in the treatment of a subject suffering from sexual dysfimction such as priraar^ imjx^icncc aiid'or decreased libido and/or desiring inacased hbido and sexual, power dn\'c ar^d stamiua. coiaprising first and second components, said first compiisiug any of the pregnane gKcosidis or mixtures thereof, and the said second comprising the witlianolides of AshwagandhaCas the evtraci of

VVitliania soiunjfi.Ta or otiiorudse). the oiiicvuii of said lirsi being to tiic cxicnt of »Toni riboul 10 lo 20 parts by vvt. and that of said second being to the extent of from alM>nt 4 to 8 parts by \>1., the amount of said first being specified herein in tenris of the moLecuIarly equivalent amount of the pregnane gi3'coside, caratuberside.
17. A pharmaceutical composition as claimed in the piecoding claim 1, for use "as a treatment dose and/or a maintenance dose in the treatment of a subject suffering from sexual dysfunction such as primary impotence and/or decreased libido and% desiring increased libido and sexual power, drive and stamina, comprising first and second components, said fii-st comprising any of the pregnane glycosides or mixtures thereof, and the said second comprising Shilajith, the amount of said first being to tlie extent of from about 10 to 20 parts by \vt. and that of said second being to the extent of from about 4 to 8 parts by wt., tlie amount of said first being specific^ herein in terms of the molecularly equivalent amount of tlie pregnane glycoside, oiratuberside.
lo. A pharmaceutical composition as claimed in tlie preceding claim 1, for use as a treatment dose and/or a maintenance dose in the treatment of a subject suffering fi-om sexual dysfunction such as primary impotence and/or decreased libido and/or dairing increased libido and sexuaL power drive and stamina, comprising first and second components, said first comprising any of the pregnane glycosides or mixtures thereof, and the said second comprising Fenugreek extract containing about 50% Prolodioscia, the amoimt of said first being to tlie extent of from about 10 to 20 parts by ^vt. Had tliat of said second being to the extent of from about 10 to 20 parts by wt., ibe amount of said first being specified herein h\ terms of the -nolecularl}' equivalent amount of the pregnane glycoside, caratuberside.
L9 A pliannaceutical composition as claimed in ihe preceding claim 1, for use as a treatiuent dose and/or 'i niainteiumce dose r a subject desiiing treatmenf oft\\c aging syndrome, comprising firii and second componems, said first comprising any of the pregn;ine glycosides or mixtures thereof, and including therein the saponin glycosides of the caraliuina species of plants, and the said second comprising tlie catechins of Green tea. the amoimt of said first and the said second components and of said saponin gI>cosides each being to tlie extent ot from about 4 lo 8 paits by M , tlie amount of said first being specified herem in tenns of the moleculariv equi\alom amcnmt of the pregnane glycoside, caratuberside.
'A). A pharmaceutical composition as claimed in tlie preceding claim 1. for use as a treatment dose and/or a maintenance dose for a subject desiring treaJineni of irtc agim; svndrome, comprising first and second components, said first comprising any of the pre.gitane glycosides or nu.xtures thereof, and the .said second comprising Green tea extract containmg ab-oiii 40% catechins, tlie amount of said first being lo

the extent of from about 4 to 8 parts b> wt. and of the said second being to the exicnt of from about 10 to 14 parts by \\1., the amount of said first being specified herein in terms of the molecularly cqui\'alent amount of the pregnane glycoside, caratuberside.
A piiarmaceutical composition as claimed in tlie preceding claim I. for use as a treaimeiu dose and/or a maintenance dose in a subject suffering SDHI the menopausal s> ndrome or desiring allcMation from hot flushes and menopausal distress, comprising first and second components, said first comprising any of the pregnane glycosides or mixtures thereof, and the said second comprising Red clover extract containing about 8% isoflavones, the amoimt of said first being to the extern of fi-om about 2 to 4 parts by vd. and of Hie said second being to the extent of from about 4 to 8 parts by wt., tlie amount of said first being specified herein in terms of the molecularly equivalent amount of the pregnane glycoside, caratuberside.
A pharmaceutical composition as claimed in tlie pieceding claim 1, for use as a treatment dose and/or a maintenance dose for a subject suffering from the menopausal s}'ndromc or desiring alleviation fi-om hot flushes and menopausal distress, comprising first and second conTponems. said first cofnprising any of the pregnane glycosides or mixtures thereof, and the said second comprising Hops flosNer extract containing about 5% tiiphy toestrogens, the amount of said first being to the extent of from about 2 to 4 parts bv wt. and of tlie said second being to the extent of fi'oni about 4 to 8 parts by wt., tlie amoimi of said first being specified herein in terms of the mokciilarh eq■ai^'?lent amcimt of the pregnarie glycoside, caratuberside.
A pliannaceuticai composition as claimed in the preceding claiin L for use 3S a trea^inem dose and^'or a maintena^ice dose for a subject suffering frora tlie menopau^'^1 syndrome :r desi'ing alleviation /roin hoi tluslies and menopausal disti^ss, comprising first and sccon romponcris. s;id firsi comprising an} of the pregiume glycosides oi mixtures tiicreof, and the said second coripnsmg Pcrr,egrapate extract containing about 10% Eilagic acid, tlie amount of said first being .c iie ^>.i^rtt c>t' from aboiu ^ to 4 p^irts by wt. and of tlie Siiid second being tc the extent of firom about 4 r.o S parts by wt.. the amount of said first being specified herein in tenns of tlie molecularly equi'-aient amouiu of the pregnane Glycoside, caratuberside.
0
A pharuiaccuiici:! coniposition as claimed in tlie preceding claim 1. for use rs a treatment dose and/or a maintenance dose for a subject suffering from tlie menopausal syndrome : r dc^inng alicNiation fiom hot flushes and menopausal distress, comprising first and second componcnis. said first comprising any of the pregnane gl>cosides or mixtures thereof, and the said second cor:prisaig Liqaorice extn^.i containing about 5% Triphjtoestrogens, the amount of said first bemg to the extent of from ab'3ui 2 t 4 parts by wt. and of the said second being to 'he extcii^ of fiorn about 4 re S ppns by wt., die aiaou;V

of said first being specified herein in terms of the mclecularly equi^'alent amount of the picgnane glycoside, carahiberside.
25. A pharmaceutical composition as claimed in the preceding claim 1, for use as a treatment dose and/or a raainteuance dose in the treatment of a scbiect suffering from hypercholesterolemia and /or desiring reduction of blood cholesteroL comprising first second and third components, said first comprising any of the pregnane ^cosides or mixtures thereof, the said second comprising Hibiscus subdarifa extract containing about 25% pohphenols and the said third comprising Commiphora mukul extract containing about 3% gugulstcrones, the amouiu of said first being to the extent of from about 5 to 20 parts by wt. and of the said secoiKl being K> the extent of from about 6 to 10 parts by wt. and the amoiml of said third being to the extent of fiom about 4 to 8 parts by wt., amount of said first being specified herein in tenns of the moleculariy equivalent amount of the pre^^iane glycoside, caraluberside.
26. A pharmaceutical composition as claimed in the preceding claim 1, for use as a treatment dose and/or a maintenance dose in the treatment of a sd^ect suffering from hypercholesterolemia and /or desiring reduction of blood cholesteroL comprising first and second components, said first comprising any of the pregnane gh cosides or mixtures thereoC and including therein the saponin glycosides of the caralluma species of plants and Ac said second comprising the catechins of Green tea, the amount of said first being to the extern of fiom abcu£ 90 to 150" parts by wt, that of the said second being to tlie extent of fi'om about 100 to 200 parts by wt and the amount of said saponin glycosides being to the extent of from about 2 to L5 pans b}' wt„ tbe amount of said first being specified herein in terms of the moleculariy equivalent amoma of the pr^nane glycoside, caratuberside.
27. A pharmaceuucal composition as claimed in the preceding claim 1. for use as a treatment dose and/or
a maintena:ice dose for a subject desiring anti-oxidant action and/or ensuring general health and
fitness, comprising first and second coraponentL said first comprising any of the pregnane glycosides
or mixtures thereof and including therein the saponin glycosides of the caralluma species of plants, and
the said second comprisir^ the catechins of Green tea(as Green tea extract or otherwise), the amount of
baid first and second components and said saponin glycosides being each to the extent of from about 4
to 8 parts by \\~ . the amoizni of raid first t>emg specified herein m terms of the moleculariy equivalent
amount of tliC pregnane ghcoside, caratcberside.
28. A phannaceutiCal composition as claimed m the preceding claim 1. for use as a treatment dose and/or a
maintenance dese for a sidgect desiring aEii-oxidant action and/or ensuring general health and fitness,
comprising first and second conqwneias. said first comprising any cf the pregnane glycosides or
mixtures tliereof and the said second OHs^jrising Green tea extract containing about 40% catechins.

(he iKU'^unt oi K sd fiibt component being to the exieii: of from about 4 to 8 parts by wt. and tlie amount of said second being to the extent of from about 10 to 14 pans by \M., tlie amount of said first being specified herein in terms of the moleciu'arfy eqim^Jent amouia of the pregnane glycoside, caratuberside.
29. A pharmaceutical composition as claimed in the preceding ciaim 1. for use as a maintenance dose in tlie treatment of a subject suffering from clinical depression or desiring mood elevation, comprising first and second components, said first comprising am of the pregnane glycosides or mixtures thereof, and the said second comprising the withanolides of A5hwagaia3ha(as the extract of Withania somnifera or otlierwise), the amount of said first being to ti^ extent of firt3sn about 5 to 10 parts by ^vt, and that of said second being to the extent of from about 2 lo 4 parts by w?_, the amoimt of said first being specified herein in terms of the molecularly eqimaleis amoma of the pregnane glycoside, caratuberside.
30. A phannaceutical composition as claimed in the jneceding claim L foruse as a maintenance dose in the treatment of a subject suffering sexual dysfimcticsi such as piimary impotence and/or decreased libido and/or desiring increased libido and sexu^ power dnvc and stamina, comprising first and second components, said first comprising any of the pregnane ^c 31. A phannaceutical composition as claimed m the preceding ciaisn 1. for use as a maintenance dose in tiie treatment of a subject suffering scxijal d>sfiirictic' such as primar\ impotence and/or decreased libido and/'or desiring increased libido and sexoai pct^tr, drive and siamina, comprising first and second components, said first comprising any of the pr^gna.-^ glycosides or mixtures thereof, and the said second comprising Sliilajith, the amount of said first being lo the e.Ktent of from about 5 to 10 parts by -^vt. and that of said second being to the exiem of fi-ois about 2 to 4 parts by wt., the amount of said first being specified herein in terms of tlie raoleoilarly ecprvalent amount of the 'iregnane glycoside. c 32. A phannaceutical composition as claimed in the precsuing cLscn 1. for use ds a maintenance dose in the treatment of a subject suffering sexual d\-sfiincboi: rach as priman- impotence and/or decreased libido and% desiring increased libido and sexiial po^er dri^e and stamina, comprising first and second components, said first comprismg an\' of the rs^gnane «i> resides or mixture thereof and the

said second comprising Fenugreek extract containing about 50% Proiodioscin, the amount of said first being to tlic extent of from about 5 to 10 parts by \^t. and thai of said second being also to the extent of from about 5 to 10 parts by wt., the amount of said first being specified herein in terms of the molccularly equivalent amount of the pregnane glycoside, caratuberside.
33. A phannaceutical composition as claimed in the preceding claim 1, for use as a maintenance dose for
a subject desiring treatment/ management of tlie aging syndrome and/or ensming general health and
fitness, comprising first and second components, said first comprising any of the fniegnane gl}'cosides
or mixtures tliereof and including therein the saponin glycosides of the caralluma species of plants, and
the said second comprising the catechins of Green tea{as Green tea extract or otherwise), the amount of
said first component being to tlie extent of from about 10 to 20 parts by wt. and of said second being
to tlie extent of from about 5 to 10 parts by wt. and of said saponin glycosides from about 12 to 30
parts by wt., tlie amount of said first being specified herein in terms of the molecularly equivalent
amoimt of the pregnane glycoside, caratuberside.
34. A pharmaceutical composition as claimed in the preceding claim 1, for use as a treatment dose and/or a maintenance dose in the treatment (rfa subject suffering from osteo-arthritis of weight-bearing joints and/or desiring relief from joint pains and inflammation and the rejuvenation of the joints comprises first and second components, said first comprising any of the pregnane glycosides, or mixtures thereot said second comprising Glucosainine(as sulphate or otherwise), the amount of said first being to the extent of from a'oout twelve to thirty partes by wt, and of said second being to the extent of from about 40 to 100 parts by wt.. the amoimt ot said first being specified herein in terras of the molecularly equivalent amomit of tlie pregnane glycoside, caratuberside and the said glucosamine amount specified herein being as the sulphate salt thereof
35. A pharmaceutical composition as claimed in the preceding claim I, for use as a treatment dose and/or a maintenance dose in the treatment of a subject suffering from Type 2 diabetes and/or desiring control/regulation of blood sugar comprises fir^ and second components, said first comprising any of 'he pregnane glycosides, or mixtmres tliereof and including therein the bitters of the caralluma species of plants, and said second comprising 4-hydroxy-iso-leucine(as Fenugreek extract or otherwise), the amount of said first being to the extent offromnbout^lOO to 250 parts by wt. and of said second being lO the extent of from about 100 tc 200 parts'by \Vt.. the amounts of said bitters being to die extent of
from about 2 to 8 parts by wt. and the amount of said first being specified herein in terms of the molecularly equivalent amount of tlie pregnane gl>coside, caratuberside.
36. A pharmaceutical composition as claimed in the preceding claim 1, for use as a treatment dose
and/or a maintenance dose in the treatment of a subject suffering from mild to moderate

hypertension, comprising ilrst aiid second couiponenls, said first comprising any of the pregnane glycosides, or mixtures thereof and tlie said second comprising (-)-hydro\ycitrate(riCA)(in the form of Garcinia Cainbogia extract or otherwise) the amount of both said first and second components each being to the extent of from about 125 to 250 pans by \vt., the amount of said first being specified herein in terms of the molecularly equivalent amount of the pregnane glycoside, caratuberside.
3 7. Tlie phanuaceutical composition as claimed in any of the preceding claims 1 to 36. wherein said
pregnane gl>'Cosides(PG) principally comprises caratuberside and bouceroside including the isomers tliereof
38. The pharmaceutical composition as claimed in tlie preceding claim 37, wherein said caratubersides and boucerosides comprise 99% or more by weight of said glycosides.
39. The phannaceutical composition as claimed in the preceding claim 38, wherein the ratio of said caratubersides to boucerosides is from about 9:1 to 19:1 by weight.
40. Tne pharmaceuticaJ composition as claimed in any of the preceding claims 1 to 39, wherein said pregnane giycoside(s) are of plant origin and comprise the extract(s) of one or more of the carailuma
species of pi anrs.
41. The pharmaceiuical compcsition as claimed in ilie preceding claim 40, wherein said pregnane glycoside(s) comprise tlie extract of the species carailuma fimbriata.
42. The pliarraaceuticai composition as clauned in any of the preceding clainiS 1 to 41, wherein said
pregn. le gi\cosidc(s) aie in tlie luicoaxerted fornL
43. Tlie phannaceutical cotnj^osiTiOu as claimed in any of the preceding claims 1 to 42, wherein said
pregnane g]\ cosid?(s) arc m the form of an aqueous ethanolic extract the said pregnane glYCoside(s)
content therein being p eferably either from about 5% to 15% w7w or exceeding about 15% \v/\\.
4 4. Tlic phannaceutical composition as claimed m any of the preceding claims 1 to 42, wherein said
giycoside(s) are in tiie adsorbed form over a suitable excipient,
45. llic pharmaceutical composition as claimed in the preceding claim 44, wherein said excipient is eitlier Malto Dextrin or Magnesiimi Carbonate

46. Tne pharmaceutical composition as claimed in any of the preceding claims 1 to 41. wherein said pregnane glyccside(s) and the other components and constituents thereof are in tlie unconverted form or in the form of any of the jAannaceutically accepted salts and/or on any of the pharmaceutically accepted carriers and comprise any of the pliannaceuticall\ accepted flavoin^ and/or colours.
47. The pharmaceutical composition as claimed in any of the preceding claims 1 to 46. \\ herein said treatment and maintenance doses are in any of the pharmaceutically accepted forms such as capsules, tablets, syrups, sprays and others.
48. A process of admixture for making a pharmaceutical composition as claimed in the preceding claim 1 comprising the admixture of said first component with saia one or more additional components, namely, said second, third, fourth and higher order components.
49. A process of admixture for making a phannaccutical composition as claimed in the preceding
claim 48, for use as a treatment and/or a
maintenance dose in:
i. tieatment/man^ement of obesity;
ii. reducing appetite levels;
iii- reducing waist, arm and hip circumfeiences.
iv. weight-reduction;
V. reduction of Wood cholesterol; and
vi. reduction of BMI,
ctf a subject, \^'herein said composition comprises first and second components said first being any of tlie pregnane glycosides, or mixtures thereof, and tli said second being (-)-hydrox}'citrate(HCA)(in rhe fonn of Garcinia carabogia extract or othen\ise), and wherein fi'om about four to eight parts by v.t, of said first are adimxed witii n-om about five to ten parts by wx. of said second, the aniount of said first bcmg specified herein in terms of the molecularly equivalent aniomit of the pregnane gh^cosidc. caj^atuberside.
50. A process of admixtin-e for making a phanuaceutical composition, as claimed in the preceding claim
48, for use as a treatment dose and/or a maintenance dose in:
i. trcatmerX'maiiagement of the aging s>Tidrome
ii. skin nourislunent and maintaining skin elasticit\' and health;
iii. protection from and prevention of cancer, and
iv. anti-oxidant action and ensuring general healili and fitness,
of a subjcci, v'hercin said composition comprises first second, third and fourth components, said first

being any of the pregnane glycosides, or mixtures thereof, said second being Zinc monometluoniac said third being Citnis bioflavonoids and said fourtli being selenium(as chelate or in anotlier form), and wherein the undermentioned are admixed together:
i. from about 25 to 50 parts by weight of said first component.
ii. from about 50 to 75 parts by M.,of said second compoi^nt.
iil from about 75 to 125 parts by wt. of said third component, and
iv. from about one to four parts by wt. of said'fourtli component,
the amount of said first being specified herein in terms of the molecularly equivalent amount of tlxc pregnane glycoside, caratuberside,
51. A process of adn: 'xture for making a pharmaceutical composition, as claimed in the preceding claim
48, composition for use as a treatment dose and/or a maintenance dose in the treatment of a subject
suffering from the menopausal s>^ndrome and/or desiring alleviation from hot flushes and menopausal
distress, wherein said composition comprises first, secoiid, third and fourth components, said first
being any of the pregnane glycosides, or mixtures thereof, said second being Zinc monomethionine,
said third being Citrus bioflavonoids and said fourth being seleniimi{as chelate or in another form), and
wherein tiie belowmentioned are admixed together:
i. from aboyt 25 to 50 parts by weight, of said first comp(»3ent.
ii. from about 50 to 75 parts by wt. of said second compoi^nt.
iii. from about 75 to 100 parts by wt. of said third component, and
iv. from about thice to five parts by w1. of said fourtli component,
tlie amount of said firsl being specified herein in terms of the moleadarly equivalent amomit of the pregnane glycoside, caratuberside.
52. A process of admixture for making a pharmaceutical composiiion. as claimed in the precedi . claim
48, for use as u tieatmen* dose and/or a maintenance dose in the treatment of a subject des!rmg a
moderate increase in BMR and^or in stamina, endurance and energj- levels, wherein said composition
comprises first and second components, said first being any of the pregnane glycosides, or mbrtures
thereof and including tlierein the saponin glycosides of the caralluma species (^plants, and il^c said
second Lliiig tlie catechins of Green tea(as Green tea exiract or otherwise), and wherein tlie following
are admixed'
i. from aoout 4*^ to 75 purts by wt., of said first component,
ii. from about fifty Ic one hundred parts by wt. of said second component
tlie amount of said saponin glycosides being from about one to seven and a half parts b>' wt., ana the amount of said^first being specified herein in terras of the molecularly equivalent amount of the pregnane glycoside; caratuberside.

53. A process of admixture for making a phannaceutical composition, as claimed in tl\e preceding claim 48, for use as a treatment dose a^d/or a maintenance dose in the treatment of a subject desiring an increase in BMR and'or in stamina, endurance and energy levels, wherein said coniposition comprises first, second and tlmd componsfrss, said first being any of tlie pregnane glycosides, or mixtures thereof and including therein the saponn glycosides of tlie caralluma species of plants, said second being the catechins of Green tea(as Green tea extract or othenvise) and said third being the withanohdes of Ashwagandlia(in the form of Wlibania somnifera extract or otherwise) and w^herein from about 50 to 100 parts by wt., of each of said first second components are admixed together, the amount of said saponin glycosides being to the extent fi-om about one to ten paits by wt., and the amoimt of said first being specified herein in lenns of the molecularly equivalent amount of the pregnane glycoside, caratuberside.
54. A process of admixrure for maMng a pharmaceutical composition, as claimed in the preceding claim 48, for use as a treatment dose and/or a maintenance dose in the treatment of a subject sufi'ering from osteo-arthritis of v^^ght-bearing joints and/or desiring relief from joint pains and inflammation, wherein said composition comprises first, second and third components, said first being any of the pregnane gi}'COsides, or mixtures iher^f, said second being Glucosamine(as sulphate or otherwise) and said third being Rutin(or ocber bioflavonoid), and wherein the following are admixed together:
i. from about 45 to 135 parts by svi.. of said first component,
ii. from about 125 tc 375 parts by wt. of said second component and
iii. from about 35 to 125 paits b> ^vt., of said third component,
the amomit of said first oeing speciiied herein in terms cf the molecularly equivalent amount of the pregnane glycoside, caratuberside and the said glucosamine amoimt specified herein being tliat of the sulphate salt tbereof.
55. A process of admixrure for m^^sing a pliarmaceuiicalvCGn^wsition. as claimed in the precaJing claim
48, for use as a treatment dose andy'or a maintenance dose intlie treatment of a subject sufi'ering from
osteo-arthritis of v-eighi-beanng jomis and/'or desiriugrelief from joint pains and inflammation,
wherein said composition con::prises first and second lon^itents, said first being an}' of the pregnane
glycosides, or mixtrires therec:' and said second being Rutin(or ciiier bioflavonoid), and wherein die
folloxving are admixed: .. r • '^"'
i from about 4 tc 1' pans by wt. said5«st pompoftent, and
u. from about 10 tc 7 tlic amoimt of said first being specified hereipiijterpj&^f the Molecularly equivalent amoimt of the pregiume gi> coside. caratuberside.

56. A process of admixture for making a pharmaceurical composition and dicias> supplement, as claimed
in tlie precedii^ claim 48, for use as a treatment df>se and/or a maiaenance Jose m tlie treatment of a
subject suffering from osteo-arthritis of weight-bearing joints and/'cr desiiEje relief from joint pains
and inflammation and the rejuvenation of the joints. «1ierein said composiiaan comprises first and
second components, said first being any oi'the pregrssne glycosides, or raixEsires thereof, said second
being Gluco$amine{as sulphate or otherwise), and w herein the foliowing are admixed:
i. from about one to two parts by wt. of said first component, and
ii. from about 6 to 7.5 parts by %vt., of said second.
the amount of said first being specified herein in terms of the mokcularly equivalent amount of the pregnane glycoside, caratuberside and the said glucosamine amount specifed herein being tliat of the sulpliate salt thereof.
57. A process of admixture for making a pharmaceutical composition, as claimed in the preceding claim
48, for use as a treatment dose and/or a maintenance A)se in the treatment c£ s subject suffering from
osteo-arthritis of weight-bearing joints and/or desirins relief from joint pains and inflammation,
wherein said composition comprises first, second and third components, sam first being any of the
pregnane glycosides, or mixtures thereof said second being Riztin(CB' other'msfiavonoid) and said third
being Bamboo Silica(of 70% concentration or other), and wberein tne foUcwag are admixed together:
from about 12 to 30 parts by wt., of said first conqjonent
li, from about 30 to 90 parts by v\1. of said second compDnent. ax^
iii. from aboui 5 to 10 paits by wt., of said thixd caiiQ)ona3t,
the amount of said first being specified herein in terms of the moleculariy espirv ^lent an:ount of tlie
pregnane glycoside, caratuberside.
58. A process of admixture for making a pharmaceuncal composriioa ai claitnei in the prec^^ding claim
48. for use us a treatment dose and/oi a maintenance ciose in xh£ trcaouieni. cf H subject sufl-enng from
osteo-arthritis of weight-bearing joints and^or desinug relief fnom jiomt po^is arid irulamn?atioiu
wherein said composition con^)riscs first second third and foarth componenis. said firsi being imy of
the pregnane glycosides, or mixtures thereof, said sec;?nd beiiffi QiKOsanuias as sulphate or
oihenvise), said rtiird being Rotin(o{ other biofla\'onoKl) and said f^^mh bcnuz Bamix>o Siiica(of 70%
concentration or other), and wherein the following are adnuxesa togeiber:
i from about 9 to 27 parts by wt., of said Gist componcnL
ii. from about 25 to 75 parts by w1., of said second compotient
iii. from about 7.5 to 25 parts by wi.. of sa^i third compccent aix
i\. from about 5 to 10 parts by wt.. of said fourth comporeit
the airount of said first being specified heiein in terms of the molecuiariy eo^rialent amount of tlie pregnane glycoside, caratuberside.

59. A process of admixture for making a pharmaceutical composition, as claimed in the preceding claim
48, for use as a treatment dose and/or a maintenance dose in tlie treatment of a subject suffering from
elevated blood sugar levels or TN'pe 2 diabetes and/or desiring controi/regula'i^on of blood sugar,
wherein said composition comprises first and second comjx)nents, said first being any of the pregnane
glycosides, or mixtures thereof and including therein the bitters of the caralluma species of plants, and
said second being 4-h} droxy-iso-leucinc(as Fenugreek extract or otherwise), and wherein the
following are admixed:
i. fi-om about 100 to 250 parts by \vt. of said fu-st component, and
ii. from about 100 to 200 parts by wt., of said second component, tlie amoimts of said bitters
being to the extent of from about 2 to 8 parts by wt. and the amount of said first being specified herein in tenns of the molecularly equivalent amount of the pregnane glycoside, caratuberside.
60. A process of admixture for making a phannaceutical composition, as claimed in the preceding claim 48, for use as a treatment dose and/or a maintenance dose in the treatment of a subject suffering from ele/ated blood sugar levels or Type 2 diabetes and/or desiring control/regulation of blood sugar. wherein said composition comprises first, second, third, fourth and fi^fth components, said first being any of the pregnane glycosides, or mixtures thereof said second being Coccinia extract containiug about 10% terpenes, said third being Bitter gourd extract containing about 8% bitters thereof said fourth being Cinnamon extract containing about 15% pol>phenols thereof and said fifth being Fenugreek extract containing about 40% 4-hydrox>'-iso-leucirte, and wherein from about 100 to 250 parts by wl. of said first component and from about 100 to 200 parts by wt. of each of said third tourth and fifth components are admixed together the amount of said first being specified herein in terras of tlie molecularly equivalent amount of the pregnane glycoside, camtuberside.
61. A process of admixture for making a pharmaceuticai composition, as claimed in tlie preceding claiui -18. for use as a treatment dose and/or a maintenance dose in the treatment of a subject ha\'ing mild to moderate hypertension, wherein said composition comprising first and second components, said first 13ing any of the pregnane glycosides, or mixtures thereof and the said second being Commiphora mukul e.^tract containing about 3% gugulsterones, and wherein from about 125 to 250 pans by ut. of each of said first and second components are admixed together, the amoimt of said first component being specified heroin in terms of iJie molecularly equivalent amount of ihe pregnane ghcoside. caratuberside.
62. A process of admixrare for making a pharmaceuticai composition, as claimed in the preceding clinn 48. for use as a treatment dose and/or a maintenance dose in the treatment of a subject sulferins from clinical depression or desiring mood cie\ation. wherein said composition comprises first and second

components, said first being any of the pregnane glycosides or luLxtures thereof, and the s?j:d second being the withanoiides of Ashwagandlia(as the extract of Withania somnifera or cther^vise). and wherein from about 10 to 20 parts by wl. of said first component are admixed with from about 4 to 8 parts by wt of said second the amount of said first being specified herein in terms of Jhc moleailarly equivalent amount of the pregnane glycoside, caratuberside.
63. A process of admixtme for making a pharmaceutical composition, as claimed in the preceding claim 48, for use as a treatment dose and/or a maintenance dose in the treatment of a subject suffering from se>aial dysfiinction such as primary impotence and/or decreased libido and/or desiring increased libido and sexual, power drive and stamina, wherein said composition comprises first and second components, said first being any of the pregnane glycosides or mixtures thereof, and the said second being the withanoiides of Ashwagandha(as the extract of Withania somnifera or otherwise), and wherein from about 10 to 20 parts by wt. of said first component ait: admixed with fiom about 4 to 8 parts by wt. of said second, the amount of said first being sT)ecified herein in terms of the molecularly equivalent amount of the pregnane glycoside, caratuberside.
64. A process of admixture for making a pharmaceutical composition, as claimed in the preceding claim 48, for use as a treatment dose and/or a maintenance dose in the treatment of a subject suflTeiing from sexual dysfunction such as prini?jy impotence and/or decreased libido and/or desiring increased Ubido and sexual power, drive and stamina, wherein said composition comprises first and second components, said ilrst being any of the pregnane glycosides or mixtures thereof and the said second being Shiiajith, and wherein from about 10 to 20 parts by wt. of said first are admixed witli from about 4 to 8 parts by wt. of said second component the amount of said first being specified herein in tenns of tlie molecularly equivalent 65. A process of admixture foi ..lalang a pharmaceutical composition, as claimed in the preceding claim 4o, for use as a treaiment dose and/'or a maintenance dose in the treatment of a subject sufix'iiag from sexual disfunction such as primar\' iir'potence and/or decreased libido and/or desiring increased hbido and sexual, power drive arid stamina, w her in said composition comprises first and second components, said frrst being any of the pregnane glycosides or mixtures thereof, and the said second being Fenugreek e>:tract contaniing about 50% Protodioscin. and wherein from about 10 to 20 parts by wt. of said fnst component are admixe::i widi from about 10 to 20 parts by wt. of said second, tl;e aiuount of said first being specified herein in terms of tlie molecularly equivalent amount of the pregnane glycoside, caratuberside.
66. A process of admixture for making a pharmaceutical composition, as claimed in the preceding claim 48, for use as a treatment dose and/or a maintenance dose for a subject desiring treatment of tlie aging

syndrcane or desiring aIie\iation from hot fludies and menopausal distress, w-herein said composition comtHises first and second components, said first being any of the {M^gnaiie glycosides or mixtures thereot and the said second being Pomegranate extract containing about 10% Ellagic add, and whereat from about 2 to 4 parts by wt of said first component are admixed with fi*om ab(»it 4 to 8 parts by wt- of the said second, the amount of said first being specified herein in terms of the molecularly equiv^em amount of the pregnane glycoside, caratubersidc.
71. A process of admixture for making a pharmaceutical composition, as claimed in the preceding claim 48, for use as a treatment dose and/or a maintenance dose for a subject suffenng from the menopausal syndnsne or desiring alleviaticm from hot flushes and menopausal distress, wherein said composition composes first and second components, said first being any of the pregnane glycosides or mixtures thereof, and the said second being Liquorice extract containing about 5% Ti^hytoestrogens, and wiiereai from about 2 to 4 parts by wt. of said first component are admixed with from about 4 to 8 parts fay wl of the said second, the amount of said first being specified herein in terms of the molecadaiij' equi\'alent amount of the i»:egnane glycoside, caratubersidc.
72. A process of admixture for making a pharmaceutical composition, as claimed in the preceding claim 48, foruse as a treatment dose and/or a maintenance dose in the treatment of a subject suffering from hypeidtK>lesterolemia and /or desiring reduction of blood cholesterol, wherein said conqx>sition composes first, second and third components, said first being any of the pregnane glycosides or mixtiKes thersot the said second being Hibiscus subdarifa extract containing about 25% polyphenols and the said third being Commiphora mukul extract containing about 3% gugulsterones, and wherein the fo^wing are admixed togdher:
i from about 5 to 20 parts by wt. of said first component,
li from about 6 to 10 parts by wt. of the said second component, and
iii. from about 4 to 8 parts by wt., of said third component,
the anaount of said first being specified herein in terms of (he molecularly equivalent aimmnt of the
pregiisne gh coside, caratubersidc.
73. A process of admLxture for making a pharmaceutical composition, as claimed in the preceding claim
48, fee use as a treatment dc le and/or a maintenance dose in the treatment of a subject sufiering from
h}^perciioIesterolemia and /or di^siring i eduction of blood cholesterol, wherein said composition
composes first and second conqwnents, said first being any of the pregnane glycosides or mixtures
thered and including tiierein the saponin glycosides of the caraliuma species of plants and the said
secoDd being the catechins of Green tea, and wherein from about 90 to 150 parts by wt.of said first is
admbisd with from about 100 to 200 parts by wt. of the said second component, the amount of said
sapoiEm glycosides being to the extent of from abouTZto 15 parts by wt., and the amount of said first

being specified herein in terms of the molecularh* equiv^iem amount of the pregnane glycoside, caratuberside.
74. A process of adii^xture for making a pharmaceutical composition, as claimed in the preceding claim 48, for use as a treatm^t dose and/or a maintenance dose for a subject desiring anti-oxidant action and/or ensuring general health and fitness, wherdn said composition comprises first and second components, said first being any of the pregnane giycosKies or mixtures thereof and including therein tlie saponin glycosides of the caralluma speaes of plants, and the said second being the catechins of Green tea(as Green tea extract or otharwise), and whereia from about 4 to 8 parts by wt, of each of said first and second conjponents are adnuxed with eadi othet. the amount of said saponin glycosides being also to the extent of fit)m about 4 to 8 parts by vit and the amount of said first being specified herein in terms of the molecularly equivalent amount of the pregnaee glycoside, caratuberside.
75. A process of admixture for making a pharmaceutical ccKapo^tion, as claimed in the preceding claim 48, for use as a treatment dose and/or a maintenance dosefer a subject desiring anti-oxidant action and/or ensuring general health and fitness, \diereui said oao3position comprises first and second components, said first being any of the pregnane ^cosidcs or mixtures thereof, and the said second being Green tea extract containing about 40% calcchias aad \*1ierein fix)m about 4 to 8 parts by wt. of said first component are adnuxed with firom:dx}ut lOtc 14 parts by wt. of said second, the amount of said first being specified herein in tenns of the mdeculadr equivalent amomit of tl^ pregnane glycoside, caratuberside.
76. A process of admixture for making a pharmaceiricai cooposition, as claimed in the preceding claim 48, for use as a maintenance dose in the treatn^it of a sabfect suffering fcom clinical depression or desiring mood elevation, wherein said composition con^jdses first and second components, said first being any of the pregnane glycosides or mixtures thereaf. and the said second being the withanolides of Ashwagandha(as the extract of Withania somnifera orofl^rwise), and wherein from about 5 to 10 parts by wt.of said first component are admixed with from about 2 to 4 parts by wt. of said second, the amount of said first being specified herein in terms of die molecularly equivalent amount of the pregnane glycoside, caratuberside.
77. A process of admixture for making a phannac^itical conposition. as claimed in the preceding claim 48, for use as a maintenance dose in the tre
by w1. of said first component are admixed witli from about 2 to 4 parts by wi. cf said seoMid, the amount of said first being specified herein in terms of the molecuiariy eqahalau amooDB of the pregnane glycoside, caratuberside.
78. A process of admixture for making a phannaceutical composition, as claimed in the {Sheading claim 48, for use as a maintenance dose in the treatment of a subject suffering fiom sexualxiy^mction such as primary impotence and/or decreased libido and/or desiring increased 13»do and sexuai power, drive and stamina, wherein said conqx)sition comprises first and second compcments. said first being any of the pregnane glycosides or mixtures thereof, and the said second being Stdlajitfa, and wterein from about 5 to 10 parts by wt. of said first component are admixed wtfi firom about 2 to 4 parts by wt. of said second, the amount of said first being specified herein in temis of the mokculariy equivalent amount of the pregnane glycoside, caratuberside.
79. A process of admixture for making a phannaceutical composition, as clanned in the preceding claim 48, for use as a maintenance dose in the treatment of a subject suffering sexual dysfimcSKsn such as primary impotence atd/or decreased libido and/or desiring increased libHio and sexual, power drive and stamina, wherein said composition comprises first and second components, said first being any of the pregnane glycosides or mixtures thereof, and the said secoid being Feougrtek extract containing about 50% Protodioscio, and wherein from about 5 to 10 parts l^ wt. of smd first conqKSE^nt axe admixed witli from about 5 to 10 parts by wt. of said second, the amount irf'saki first b^ng specified herein in terms of the molecuiariy equi\'alent amount of the pregnane ^^fcoside, caratoberside.
80. A process of admixture for making a pharmaceutical composition^ as daoned in the preceding claim 48, for use as a rriaintenance dose for a subject desiring treaunev^ man^emoit uf the aging syndrome and/or ensuring general health and fitness, wherein said composition ccHi^rises firet aisd second components, said first being any of the pregnane glycosides or mixtures tbereof and inc&iding therein the saponin glycosides of the carailuma species of plants, and the said second being ite caiechins of Green tea(as Green tea extract or otherwise), and whotiin tcom about 10 to 20 parts bv ^t. of said first component are admixed with from about 5 to 10 parts by wt. of said second, said sapcssan gl} cosides being from about 12 to 30 parts by wt. airi the amount of said fira being spedfied herean in terms of tlie molecuiariy equivalent amount of the pregnane glycoside, caratubeisade.
81. A process of admixture lor making a phannaceutical composition, as clauned in the preceding claim 48, for use as a treatment dose and/or a maintenance dose in the treatmeeti of a subjec saffering from osteo-arthritis of weight-bearing joints and/or desiring reiid*firan joint pasm and infiasnmation and the rejuvenation of the joints, wherein said composition comprises first and second components, said first being any of the pregnane glycosides, or mixtures thereof, said second being GlucosaEmne(as sulphate

82. The process of admixture for making a pharmaceutical composition as claimed in any of the preceding claims 48 to 86, wherein said pregnane glycoside(s) comprise principally caratubersidc and bouceroside induding the isomers thereof.
83. The process of admixture for making a pharmaceutical composition as claimed in tlie preceding claim 87, wherein said caratubersides and boucerosides comprise 99% or more by weight of said glycosides.
84. The process of admixture for making a pharmaceutical coraposilion as claimed in the preceding claim 88, wherein fte ratio of said caratubersides to boucerosides is from about 9:1 to 19:1 by weight
85. The process of admixture for making a pharmaceutical composition as claimed in any of the preceding claims 48 to 89, wherein said pregnane giycoside(s) are of plant origin and comprise tt extract(s) of one or more of the caralluma species of plants.
86. The process of admixture for making a pharmaceutical composition as claimed in the preceding claim 90, wherein said pregnane glycoside(s) comprise the extract of the species caralluma fimbriata.
87. nrhe process of admixture for making a pbann^ceutical composition as claimed in any of the preceding claims 48 to 91, wherein said pregnane glycoside(s) are in the unconverted form.
88. The process of admixture for making a pharmaceutical composition as claimed in any of the preceding claims 4S to 92, wherein said pregnane glycoside(s) are in the form of an aqueous etlianolic extract die said pregnane glycoi.. "^eCs) content therem being preferably either from about 5% to 15% w/w or exceeding about 15% wAv.
89. The process of adnuxture for making a pharmaceutical composition as claimed in any of the preceding claims 48 to 92, wherein said glycoside(s) are in the adsori)ed form over a suitable excipient,
90. The process of admixture for raalang pharmaceutical composition as claimed in the preceding claim 94, wherein said excipient is ^ithet Maito Dextrin or Magnesium Carbonate,
91. The process of admixture for making a pharmaceutical composition as claimed in any of the preceding claims 48 to 91, wherein said pregnane glycc»side(s) and the other components and constituents thereof are in the form of any of the pharmaceutically accepted salts and/or on any of tlic.

paairmaceuticaliy accq)ted carriers and comprise any of the phannaceulicaUy accepted lia%'eurs and/cr colours.
97. The pharroaceutical compositions comprising the prcgoane glyooade(s)(PG) in the fonn of
extracts of the caralluma species of plants or otherwise, either singly or as nuxtures thereof, for use in
the treatment/management of various symptoms/disorders in sutsects and in the
alteration/improvement/ regulation of physiological and other paiameters/conditions/fimctions of
subjects, and in the methods of said treatment/management or rfsaid alteration/improvemenl/'
regulation, substantially as hereindescribed, said pregnane glycoside(s) optionally including the
saponin glycoside(s) and/or the bitters of said caralluma species and being optionally supplemented by
one or more additional therapeutical, nutraceutical or nutritional components.
98. The processes of admixture for making the pharmaceutical compositions comprising the pregnane
glycoside(s)(PG) in the form of extracts of the caialiuma species of plants or otherwise, eithei- singly or
as mixtufcs thereof, for use in the treatment/managMiwnt of various symptoma/disorders in subjects
and in the aiteiation/improvement/regulation of physiological and other parameters/conditions.'^
fimctions of subjects, and in the methods of said treatment/mans^ement or of said alteration/
improvement/regulation, substantially as hereindescribed, saidpr^^iane glycoside(s) optionally
including the saponin glycoside(s) and/or the bittens of said caraDinna species and being op^ottsSly
supplemented by otie or more additional therapeutical, nutraceutical or nutritional components.


Documents:

384-che-2004-abstract.pdf

384-che-2004-claims duplicate.pdf

384-che-2004-claims original.pdf

384-che-2004-correspondnece-others.pdf

384-che-2004-correspondnece-po.pdf

384-che-2004-description(complete) duplicate.pdf

384-che-2004-description(complete) original.pdf

384-che-2004-description(provisional).pdf

384-che-2004-form 1.pdf

384-che-2004-form 19.pdf

384-che-2004-form 26.pdf

384-che-2004-form 5.pdf


Patent Number 210052
Indian Patent Application Number 384/CHE/2004
PG Journal Number 15/2008
Publication Date 11-Apr-2008
Grant Date 17-Sep-2007
Date of Filing 27-Apr-2004
Name of Patentee RAMASWAMY RAJENDRAN
Applicant Address PROPRIETOR, M/s. GREEN CHEM, NO. 5 BDA DOMLUR II STAGE, III PHASE, BANGALORE - 560 071.
Inventors:
# Inventor's Name Inventor's Address
1 RAMASWAMY RAJENDRAN NO. 5 BDA DOMLUR II STAGE, III PHASE, BANGALORE - 560 071.
2 KAMALA RAJENDRAN NO. 5 BDA DOMLUR II STAGE, III PHASE, BANGALORE - 560 071.
PCT International Classification Number A61 K 35/78
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA