Title of Invention	"HERBAL COMPOSITION FOR TREATING DISORDERS ASSOCIATED WITH MENOPAUSE"
Abstract	The present invention relates to a composition and a method for alleviating disorders and adverse symptoms associated with menopause. In particular, the composition has a therapeutic effect on the achievement of menopause and the disorders associated prior to the achievement of menopause.

Full Text

FIELD OF THE INVENTION The present invention relates to a composition and a method for alleviating disorders and adverse symptoms associated with menopause. In particular, the composition has a therapeutic effect on the achievement of menopause and the disorders associated prior to the achievement of menopause. BACKGROUND OF THE INVENTION Menopause is the termination of menstrual cycle in a woman, caused by changes in hormone levels that occurs over a period of time. Esterogen and progesterone are the key hormones associated with menstrual cycle and menopause, although other factors may be involved. The onset of menopause is also associated with several symptoms such as hot-flushes, cramping, numbness, nervousness, fatigue, head-ache, palpitation and menorrhagia. Menorrhagia is defined as excessively heavy or prolonged bleeding (soaking through at least a pad an hour for several consecutive hours). In a normal menstrual cycle, there is a balance between estrogen and progesterone in the body. These hormones regulate the buildup of the endometrium (uterine lining of blood and tissue), which is shed each month during menstruation. Menorrhagia may occur because of an imbalance between estrogen and progesterone. As a result of the imbalance, the endometrium keeps building up. When it is eventually shed, there is heavy bleeding. Because hormone imbalances are often present in adolescents and in women approaching menopause, this type of menorrhagia is fairly common in these groups. Menorrhagia is difficult to diagnose or even differentiate from uterine malignancy, which is an abnormality such as cancer observed in the uterine cells. Currently available remedies for these conditions are hormone therapy or esterogen replacement formulas, which are known to have undesirable side effects (US Patent 4,096,254) and therefore, hormone therapy is not a viable option. Hysterectomy - the surgical removal of the entire womb or uterus induces surgical menopause. Frequently, in addition to the uterus, ovaries are removed. As a result of this surgery, a sudden change occurs in the hormonal level in the body, often leading to undesirable side effects. Therefore, hysterectomy is also not always recommended. Menopause is accompanied by several unpleasant symptoms which are often difficult to manage. Given the changing characteristics of the hormonal imbalance during the menstrual cycle and/or menopause and the variation in the hormonal imbalance from person to person, it would be advantageous to provide a composition that can alleviate a person of the unpleasant discomfort experienced prior to menopause and have a therapeutic effect thereon. The Unani system of medicine, an ancient system of medicine, practised in India and several other Arab countries, uses herbs and other materials for treatment of various disorders. The Unani system is primarily based on the humoural theory, which presupposes the presence of four humours in a body: Dam (blood), Balgham (phlegm), Safra (yellow bile) and Sauda (black bile). The temperaments of persons are expressed by the terms sanguine, phlegmatic, choleric and melancholic, according to the preponderance of the humour (blood, phlegm, yellow and black bile) in them. The humours themselves are assigned temperaments: like blood is hot and moist, phlegm is cold and moist, yellow bile is hot and dry and black bile is cold and dry. Every person is supposed to have the unique humoural constitution which represents his/her healthy state. According to the Unani system, during menopause body temperament changes from hot and moist to cold and dry condition. If this condition is achieved slowly, the undesirable and unpleasant experiences associated with menopause may be substantially reduced. OBJECTS OF THE INVENTION The main object of this invention is to provide a Unani herbal composition which has a therapeutic effect on the undesirable disorders observed before achievement of menopause and assists a subject in achieving menopause comfortably.Another object is to provide a method for preparing a herbal composition useful alleviating disorders associated with menopause. Yet another object is to provide a method of treating, mitigating or alleviating the undesirable side effects associated with menopause and achieving menopause comfortably. DETAILED DESCRIPTION OF THE INVENTION Accordingly, the present invention provides a Unani herbal composition comprising therapeutically effective amount of: i) an extract of Woodfordia floribunda, and ii) an extract selected from Myrtus communis, Acacia arabica, Polygonum aviculare or Bees-wax. The term 'extract' as used herein is intended to include a concentrate of water soluble or alcohol soluble plant component from the concerned portion of the plant. The extract may exist as a powder or as a decoction. Woodfordia floribunda is a large shrub found in the northern parts of India. It is also called Dhataki. The flowers and leaves of this plant are often used in medicinal preparations. In the instant invention, the flowers of this plant may be used. Polygonum aviculare is a vascular flowering herb found all over India. The leaves and flowers of this plant are used in medicinal preparations. In the instant invention, the roots may be used. Myrtus communis is a herb found in north-west India. The fruits of this plant is used in medicinal preparations. In the instant invention, the fruits are used. Acacia arabica is a vascular wattle bark. It is commonly found in Punjab and is used in Ayurvedic and Unani preparations. The pods collected from the wild or cultivated trees may be used in the instant invention. Bees wax is melted, purified and used as such in the invention. The composition may comprise approximately equal amount of each of the ingredients i.e. an extract of Woodfordia floribunda, and extract selected from Acacia arabica, Myrtus communis, Polygonum aviculare or Bees-wax. The amount of Woodfordia floribunda used may be in the range of 8-15% w/w, while the rest of the herbs may be in the range of 20-25%w/w. An advantage with bees wax is that there is no need to add any preservatives or stabilizers to the composition that may be prepared. Bees wax may be mixed with any one or more of the herbs selected from Acacia arabica, Myrtus communis, Polygonum aviculare or Woodfordia floribunda. More preferably, 30-50% w/w of bees-wax may be mixed with 50-70% w/w Woodfordia floribunda. 50-80% w/w of bees-wax is mixed with 20-40% w/w Acacia arabica._ An example of a variant composition is : (i) Acacia arabica - 5 - 10 mg (ii) Woodfordia floribunda - 3 grams, (iii)Polygonum aviculare - 50 ml, (iv}Myrtus communis - 50 ml Several herbal compositions may be prepared using the recited herbs. All these combinations are encompassed within the scope of this invention. It is pertinent to note that the ingredients of the composition as a combination exhibit a synergistic effect, in the sense that the ingredients of the composition exhibit a far greater therapeutic effect on menopausal disorders than the individual ingredients themselves. The ingredients when combined act together in synergy. The composition is not a mere admixture of herbs. The composition and the synergistic effect thereof is described in detail in the Examples. Further, the invention provides a process for preparing a composition useful in alleviating disorders associated with menopause, comprising: i) preparing a first alcoholic extract of an extract of Woodfordia floribunda, and ii) preparing a second alcoholic extract of plants selected from Myrtus communis, Acacia arabica, Polygonum aviculare or bees-wax, iii) subjecting the first and second extracts to distillation and obtaining a filtrate, iv) drying the filtrate to obtain a fine powder, and v) mixing the powder thoroughly to obtain a composition. In this process, the alcohol is selected from ethanol. methanol, propanol and butanol. Distillation may be effected by fractional or simple distillation. Preferably, 30-50% w/w of bees-wax is mixed with 50-70% w/w Woodfordia floribunda. Preferably, 30-50% w/w of bees-wax is mixed with 50-70% w/w Acacia arabica. The ratio of Polygonum aviculare to Myrtus communis is 1:10 to 1:15. As such, the herbal composition of this invention is prepared by taking the individual herb/plant parts washing and drying the plant part, grinding and preparing the desired extract of plant parts such that it is free from impurities. The resulting extracts are collected by vacuum drying and mixed in amount that are physiologically acceptable to a subject. The mix may be encapsulated and prepared as a tablet or formulated that physiologically acceptable vehicle into unit dosages. A unit dosage is a therapeutically effective amount of each herbal extract for a single administration per day to a subject. It depends on various factors including health, age of a subject, condition of the subject being treated, etc. The period of treatment is also an important factor. Therapeutically effective amount means an amount of the extract in conjunction with other extract of the composition which promotes the ability of the composition to alleviate symptoms associated with menopause. The composition may be administered orally as a tablet, as a capsule, as a powder or as a liquid preparation. Best results are achieved when administered as a capsule or as a solid with water or as a liquid preparation. The capsule (hard or soft) may be prepared using conventional pharmacological principles. For example, the powder of the active ingredients such as Woodfordia floribunda, Myrtus communis, Acacia arabica and Polygonum aviculare may be taken in an appropriate effective amount and rolled into a capsule or tablet using Bees-wax as a vehicle. Bees-wax acts as a preservative and as an anti-inflammatory agent and also ensures that the product has a long shelf-life. In the alternative, the active ingredients recited above may be mixed with pharmacologically acceptable carrier such as corn starch, lactose, sucrose, sorbitol, talc, magnesium stearate, gum, etc. or a pharmacologically acceptable diluent such as water to form a composition. It may then be moulded into tablets.Liquid preparations for oral administration may be prepared in the form of syrup, suspension or a decoction. The syrup may be a sweet viscous solution of sugar in water containing the ingredients recited above. It can be preserved by adding glycosine, methyl paraben and storing at a temperature not exceeding 25°C. A suspension may also be prepared in the alternative, wherein the ingredients of the composition may be finely divided and suspended or dispersed in a liquid or semi-solid vehicle. The composition of the invention may also be formulated as a decoction wherein the active ingredients may be soaked in water and boiled for a few minutes. The liquid obtained is used as such. The capsule, tablets or liquid preparations may be taken together with water prior to the meal 2 times a day. The treatment may last for 9 to 15 days in each menstrual cycle commencing from the 20th day for 3 consecutive cycles with a daily dosage of 3-10 gms of the composition. The exact dosage can be devised by a skilled person based on factors such as health, age, condition of subject, etc. The invention is now illustrated by the following Examples and case studies which are not intended to limit the scope of the invention in any manner. Example 1 Method of extraction The leaves of Woodfordia floribunda were collected, washed thoroughly to remove all the dirt and dried in shade. The dried leaves were then pulverized and a fine powder was prepared with granules of mesh size about 0.5 to 5 microns. Similarly, the fruits of Myrtus communis were collected, washed thoroughly, dried in shade and a fine powder was prepared. The pods of Acacia arabica was also collected and a fine powder was prepared. Each of the powders thus prepared was subjected to alcohol extraction. The alcoholic extract was collected. The alcohol used may be such as methanol, ethanol, propanol or butanol. The impurities were distilled off and the filtrate was dried under vacuum to obtain a fine powder for subsequent use. Distillation may be simple or fractional distillation. The powder of all the three ingredients was mixed together and dried under vacuum for future use. Example 1 Method of extraction The leaves of Woodfordia floribunda were collected, washed thoroughly to remove all the dirt and dried in shade. The dried leaves were then pulverized and a fine powder was prepared with granules of mesh size about 0.5 to 5 microns. Similarly, the roots of Polygonum aviculare were collected, washed thoroughly, dried in shade and a fine powder was prepared. The pods of Acacia arabica was also collected and a fine powder was prepared. A fine powder was also prepared from the fruits of Myrtus communis. Each of the powders thus prepared was subjected to alcohol i.e ethanol extraction. The alcoholic extract was collected. As in Example 1, the impurities were distilled off and the filtrate was dried under vacuum to obtain a fine powder for subsequent use. The powder of all the three ingredients was mixed together and dried under vacuum for future use. Example 3 Preparation of a tablets (a) Bees-wax was melted, poured drop bydrop into clean hike-warm water so that its impurities settle down and the pure bees-wax was removed from the surface. Then it was mixed with the powder of Woodfordia floribunda in the following ratio: 50 - 70% + 30 - 50% Powder Bees-wax Then tablets were formed of uniform size and stored under cool and dry condition, with temperature not exceeding 25°C (b) Bees-wax was cleaned and mixed with the powder of Acacia arabica in the following ratio: 60 - 80 % + 20 - 40% Powder Bees-wax Then tablets were formed of uniform size and stored under cool and dry condition with temperature not exceeding 25°C. Example 4 Preparation of decoction Roots of Polygonum aviculare and fruits of Myrtus communis were washed and dried in shade separately. Then coarse powder was made of each separately. Then separately boiled in water in the ratio of 1: 10 to 1:15 for 3 to 5 minutes. Extract was taken and cooled down. If desired, preservative and sweetener may be added to this liquid preparation. The preparation is stored in a dry and cool place. Example 5 Case studies The preparation illustrated in Examples 1 to 3 above were tested on volunteers. The course of treatment and the results of these volunteers who have taken this treatment is reproduced herebelow. Case 1: The subject was a 42 years old female, diagnosed as having premenopausal menorrhagia. The subject complained of breathlessness, giddiness, head-ache in addition to heavy blood loss. The subject was advised to take the preparation of Example 2, two times a day with water before her meal (breakfast and dinner). The subject continued this treatment for 3 cycles. After completion of treatment, pap smear, the sanitary wear were some of the criteria observed and significant reduction in blood loss was reported. It came down to 13 to 2 wears per cycle. Head-ache and giddiness also disappeared. Case 2: The subject was a 35 years old female who complained of hot flushes, head-ache, severe cramps and such symptoms. The subject took the tablets prepared according to Example 2 for 3 cycles. At the end of the treatment, significant reduction in blood loss together with relief from head-ache, cramps, etc. was observed. Case 3: The subject was a 46 years old female complaining of pain in the joints, giddiness, irritability, head-ache apart from severe blood loss during the cycle. The subject took the decoction prepared according to Example 3 for 3cycles. The subject reported complete relief from giddiness, head-ache, pain in the joints and significant reduction in the blood loss during cycle. The results of these and other subject are reported in the Table herebelow. Table 1 Age group: 35 to 40 years Duration of treatment: 10 days in each cycle commencing from 20th day for 3 consecutive cycles (Table removed)Note: + = indicates presence of symptom - = indicates absence of symptom Table 2 Age group: 41 to 45 years Duration of treatment: 10 days in each cycle commencing from 20th day for 3 consecutive cyclesNumber of patients: (Table removed)7Note: + = indicates presence of symptom - = indicates absence of symptom In the case of at least 2 patients, it was observed that at the end of about 4 weeks of treatment the patient stopped bleeding and achieved menopause Table 3 Age group: 46 to 50 years Duration of treatment: 10 days in each cycle commencing from 20th day for 3 consecutive cycles Number of patients: 4 (Table removed)Note: + = indicates presence of symptom - = indicates absence of symptom The patients of all the above groups were administered a syrup prepared using the composition of Example 1. These patients experienced a significant reduction in blood loss and also associated symptoms disappeared. The patients achieved menopause smoothly. We Claim: 1. A herbal composition useful in alleviating disorders associated with menopause, said composition comprising a therapeutically effective amount of: i) a alcoholic extract of Woedfordia floribunda in a range of 5-15% w/w, and ii) a alcoholic extract selected from Myrtus communis. Acacia Arabica, Polygonum aviculare, optionally mixed with Bees wax, wherein the alcoholic extracts and the bees wax are in the range of 20-25% w/w.. 2. A composition as claimed in claim 1, wherein the extract of Woodfordia floribunda and Acacia Arabica is a powder. 3. A composition as claimed in claim 1 wherein the extract of Polygonum aviculare and Myrtus communis is a decoction. 4. A composition as claimed in claim 1, wherein ratio of each ingredient used is 1:1. 5. A composition as claimed in claim 1, wherein 30-50% w/w of bees-wax is mixed with 50-70% w/w Woodfordia floribunda. 6. A composition as claimed in claim 1, wherein 60-80% w/w of bees-wax is mixed with 20-40% w/w Acacia arahica. 7. A composition as claimed in claim 1 wherein the composition comprises: i) Acacia arabica 5-10mg ii) Woodfordia floribunda 3 gms iii) Polygonum aviculare - 50 ml iv) Myrtus communis - 50 ml 8. A composition as claimed in claim 1, wherein the alcoholic extract of Woodfordia floribunda is a powder of flowers. 9. A composition as claimed in claim 1 wherein the alcoholic extract of Myrtus communis is a decoction of fruits. 10. A composition as claimed in claim 1 wherein the alcoholic extract of Polygonum aviculare is a powder of the roots. 11. A composition as claimed in claim 1 wherein an alcoholic extract is prepared from the pods of Acacia arabica. 12. A process for preparing a composition as claimed in claim 1 useful in alleviating disorders associated with menopause, said process comprising: i) powdering the dried leaves of Wood fordia floribunda and dried fruits of Myrtus communis, extracting the powders separately with alcohol to obtain the first alcoholic extract, ii) powdering the dried roots of Polygonum aviculare and dried pods of Acacia arabica, extracting the powders separately with alcohol to obtain the second alcoholic extract, said second alcoholic extract optionally mixing with bees wax,, iii) subjecting the first and second extracts of step i) and ii) to distillation to obtain a filtrate, iv) drying the filtrate of step iii) to obtain a fine powder, and v) mixing the powder thoroughly to obtain a composition. 13. A process as claimed in claim 12 wherein the alcohol is selected from ethanol, methanol, propanol and butanol. 14. A process as claimed in claim 12 wherein distillation is effected by fractional or simple distillation. 15. A process as claimed in claim 12 wherein 30-50% w/w of bees-wax is mixed with 50-70 % w/w Woodfordia floribunda. 16. A process as claimed in claim 12 wherein 30-50% w/w of bees-wax is mixed with 50-70% w/w Acacia arabica. 17. A process as claimed in claim 12 wherein the ratio of Polygonum aviculare to Myrtus communis is 1:10 to 1:15. 18. A composition substantially as hereindescribed with reference to the examples. 19. A process for the preparation of a composition alleviating disorders associated with menopause substantially as hereindescribed with reference to the examples.

Documents:

18-del-2003-abstract.pdf

18-del-2003-claims.pdf

18-del-2003-correspondence-others.pdf

18-del-2003-correspondence-po.pdf

18-del-2003-description (complete).pdf

18-del-2003-form-1.pdf

18-del-2003-form-13.pdf

18-del-2003-form-18.pdf

18-del-2003-form-2.pdf

18-del-2003-form-26.pdf

18-del-2003-form-3.pdf

18-del-2003-form-5.pdf