Title of Invention

"A HERBAL COMPOSITION FOR MANAGEMENT OF PERIMENOPAUSAL SYNDROME AND A PROCESS FOR PREPARATION THEREOF"

Abstract

A herbal composition for management of perimenopausal syndrome and a process for the preparation thereof comprising of: dry extract of dried roots of Glycyrrhiza glabra (Madhuyesthti) 200-600 mg dry extract of dried leaves of Bambusa arundinacea (Vansh) 100-400 mg dry extract of dried rhizomes Nordostachys jatamansi (Jatamanshi) 100-300 mg dry extract of dried leaves Hypericum perforatum (Basant) 300-900 mg With or without known additive calcium sulphate.

Full Text

Field of Invention: This invention relates to a herbal composition for management of perimenopausal e im [[[|[|| ir[i "" • ••• • " "" " "— ' syndrome and a process for the preparation thereof wherein the composition has the application for management of peri-menopausal syndrome to minimize the severity of the associated symptoms in menopausal phase among the women. The composition of the present invention may also be advantageously used in reducing the vasomotor instability and psychological symptoms found to be more pronounced among menopausal syndrome-cases. Background of the Invention : Irregular menstrual cycles commonly precede the menopause and hence the exact timing of it can be recognized in retrospect (i.e. 6 months after last period). The condition of peri-menopause is referred to as that period of time around the menopause when ovarian function is erractic, with partial gonadol failure occurring in 2-3 years transitional phase during which reproduction ceases. This is a time of decreasing fertility, decreasing plasma estrogen levels and the appearance of typical symptoms of the menopausal syndrome although, of course the menstrual period will still be present. In some patients they are relatively minor but in others a major problem. The most common symptoms like vasomotor instability and certain behavioural problems particularly anxiety and depression are significantly associated with perimenopausal syndrome. The hot flushes may start when the patient still has regular periods. The fall in estrogen secretion is associated with increased bone re-absorption. There is an initial rapid loss of bone mass which eventually results in osteoporosis. Giving estrogen is referred as hormone replacement therapy (HRT) but it should not be given for long-term as it has a variety of adverse effects. Objects of the present invention. An object of this invention is to propose a herbal composition and a process for the preparation thereof useful for the management of perimenopausal symptoms by modifying the psychological disturbances as well as regulating the vasomotor instability. Another object of this invention is to propose a herbal composition and a process for the preparation thereof useful for the management of behavioural problems like irritability, hyperexcitability among perimenopausal women. Further object of this invention is to propose a herbal composition and a process for the preparation thereof useful for the management of vasomotor instability like hot flushes among the perimenopausal women. Still further object of this invention is to propose a herbal composition and a process for the preparation thereof for minimizing the rapid loss of bone mass and thus delay the severe osteoporetic chanages in future. Description of Invention; According to this invention there is provided a herbal composition for management of perimenopausal syndrome and a process for the preparation thereof comprising of : extract of dried roots of Glycyrrhiza glabra (Madhuyesthti) 200-600 mg extract of dried leaves of Bambusa arundinacea (Vansh) 100-400 mg extract of dried rhizomes Nordostachys jatamansi (Jatamanshi) 100-300 mg extract of dried leaves Hypericum perforatum (Basant) 300-900 mg With or without known additives. Further according to this invention there is provided a process for the preparation of herbal composition for the management of perimenopausal syndrome as claimed in claim 1 comprising of admixing: extract of of Glycyrrhiza glabra (Madhuyesthti) 200-600 mg extract of of Bambusa arundinacea (Vansh) 100-400 mg extract of Nordostachys jatamansi (Jatamanshi) 100-300 mg extract of Hypericum perforatum (Basant) 300-900 mg With or without known additives. It is to be noted that there is a synergetic effect among the different herbs of the present composition as individually none of the constituent herb is effective for management of peri-menopausal syndrome. The chemicals extracted out of the plants are used in the following dose range in a particular manner- 200-600 mg Glycyrrhiza glabra 100-400 mg Bambusa arundinacea 100-300 mg Nordostachys jatamansi 300-900 mg Hypericum perforatum The drugs are adminstered with varying dose schedule and a careful monitoring of the clinical symptomatology peresent different results. On the basis of oral administration of varying dose schedule, the most effective and preferred dose range comprised of- Glycyrrhiza glabra 300 - SOOmg 13ambusa arundinaceae 150 - 300mg Nordostachy Jatamansi 150-SOOmg Hypericum perforatum 300 - 600mg The remainder is optionally known additive to make the required preparation. Glycyrrhiza glabra (Madhuyeshti): This plant commonly known as 'Madhuyeshti' belonging to family "Papilionaceae" whose dried roots are extracted to collect the mixture of saponin (glycyrrjiiginj/Triterpene (glycyrrhetic acid) compounds. Various studies have suggested that this plant possessing anti^uyTammatoiy activity Drug is also useful for strengthening muscte__and__bone_in various clinical conditions, Bambusa arundinacea (Vansh): .,.^-_,.-,.>--. ..-.,. ^ ^ This plant is commonly known as Vansh' belonging to family "Gramineae" whose dried leaves are extracted to collect the mixture of the plant. It has been speculated that this plant has estrogen like action and as such it is helpful in the management of the symptoms observed in Nardostachys jatamansi (Jatamansi): This plant is commonly known as 'Jatamansi' belonging to family "Valerianaceae" whose dried rhizomes are extracted to collect the mixture of jatarnansone, terpene, esterol compounds^ Several studies have shown tn^uilizing, hypotensive and uplifting of mental function properties^ liypericum perforatum (Basant): This plant is commonly known as Basant belonging to family "Clusiaccac" whose dried leaves re extracted to collect the mixture of tiyperdn and various studies this drug particularly the hypercm and hypcrforin has shown miti-stress^ana\anti_ depressan t jpropertie£._, Example-1: The preparation containing the m^mc__£xtFact of Glycyrrhiza glabra administered in the dose of 4£o -'ing continuously for three months to the cases suTiering from perimenopausal complaints exhibited mild improvement in general feeling of wellbeing and energetic due to its properties of strengthening the muscles and bones. Example-2: The preparation containing the organic extract of Bambusa arundinaceae administered in the dose of 3ob )mg to the perimenopausal women continuously for three months showed improvement in vasomotor instability particular decrement in hot flushes. Improvement in sweating was also noticed. Example 3: The preparation containing the organic extract of Nordostachy jatamansi administered in the dose of 300mg continuously for three months to the perimenopausal women exhibited improvement: in anxiety level and mild reduction in blood pressure. Mental performance also improved to a great extent. Example-4: The preparation containing the organic extract of Hyjpericum peforatum administered in the dose of mg continuously for three wellbeing and reduced anxiety and stress. Behavioural problem improved significantly. Example -9: The Preparation containing the organic extract of Bambusa arundinacea in the dose of 3-56 }mg alongwith the organic extract of Hypcricum perforatum in the dose of fyoo 'mg exhibited marked reduction in depression level and vasomotor instability among perimensopausal cases. Example-10: The preparation containing the organic extract of Glycyrrhiza -H"' """ " "" • ' -- •--, glabra in the dose of 250mg, Bambusa arundinacea in the dose 150mg, Nordostachy jatamansi in the dose of 200mg and Hypericum perforatum in the dose of 400mg an overall improvement in the clinical symptomatology was noticed among perimenopausal women after three months therapy. The vasomotor instability particularly hot flushes reduced, anxiety and depression improved significantly and also the i general feeling of well being were reported by almost all the perimenopausal cases. rimenopausal syndrome is the condition which involves a group of psychological and physiological changes are reflected at behavioural as well as biological level particularly changes brought about in decline in female hormones. No single drug therapy can reduce the symptom complex observed in such females. The present formulation reduces the complications of menopausal syndrome and hence it improves the quality of life of female of the menopausal women. Vasomotor instability is the most important symptoms of menopausal females therefore the role of Nordostachys jatamansi is significant in reducing the CNS overacttvity_among such females. Bambusa arundinacea has shown estrog^njike,^^^^,^]!1^11^ earlier studies and hence it is effective in the management of rapid decline in the female hormone particularly the estradiol. Hypericum perforatum which has anti-depressant property regulates the mood of depressive menopausal women. Glycyrrhiza glabra prevents the rapid declines in the bone matrix and thus it minimizes the rapid qsteoporetic changes among the menopausal women. Single drug is not sufficient to overcome all the above prominent symptoms associated with peri-menopausal/menopausal women. ation comprises the organic extract of Glycyrrhiza glabra (Madhu-yesti), Nordostachys jatamansi (Jatamanshi) and Hypricum perforatum (Basant) in prescribed doses as described herein. When these mixtures were added in the formulation it modifies various complaints found among peri-menopausal women. The mixture was prepared in a specific dose, which showed the regulation of various complaints associated with peri-menopausal syndrome. If a single drug like Nordostachys jatamansi is administered it only controls the one aspect of present syndrome. While this clinical condition has a multiple complaints. The effective dose was determined by evaluating trial and error method. The novelty of this formulation is the proportion of the biologically active ingredients of the organic extract of the above four plants. Calcium sulphate was used as an additive to make the final capsule. I CLAIM; 1. A herbal composition for management of perimenopausal syndrome and a process for the preparation thereof comprising of: dry extract of dried roots of Glycyrrhiza glabra (Madhuyesthti) 200-600 mg dry extract of dried leaves of Bambusa arundinacea (Vansh) 100-400 mg dry extract of dried rhizomes Nordostachys jatamansi (Jatamanshi) 100-300 mg dry extract of dried leaves Hypericum perforatum (Basant) 300-900 mg With or without known additive calcium sulphate. 2. A herbal composition as claimed in claim 1 wherein the composition preferably contains: 300-500 mg extract of Glycyrrhiza glabra 150-300 mg extract of Bambusa arundinacea 150-300 mg extract of Nordostachys jatamansi 300-600 mg extract of Hypericum perforatum With known additive for a preparation of 300 mg/500 mg. 3. A herbal composition as claimed in claim 1 comprising the dry crude extract of dried roots of. Glycyrrhiza glabra containing glycyrrhigin and glycyrrhetic acid compound. 4. A herbal composition as claimed in claim 1 comprising the dry extract of dried leaves of Bambusa arundinacea containing plant exerted reduction in vasomotor instability showing the estrogen like action of the plant. 5. A herbal composition as claimed in claim 1 comprising the dry extract of dried rhizomes of Nordostachy Jatamansi containing a mixture of Jatamansone, terpene, sterol compound. 6. A herbal composition as claimed in claim 1 comprising the dry extract of dried leaves of Hypericum perforatum contains the mixture of hypercin and hyperforin. 7. A process for the preparation of herbal composition for the management of perimenopausal syndrome as claimed in claim 1 comprising of admixing: a) pulverizing plant part of Glycyrrhiza glabra (Madhuyesthti), Bambusa arundinacea (Vansh), Nordostachys jatamansi (Jatamanshi), Hypericum perforatum (Basant), b) deeping the pulverized plant parts in hydro alcohol for 22 to 25 hours, c) filtered the mixture of step (b) in a reactor at a temperature of 73°C and high vaccum between 400-760 MMHg. d) Mixing 200-600 mg of Glycyrrhiza glabra (Madhuyesthti), 100-400 mg Bambusa arundinacea (Vansh), 100-300 mg of Nordostachys jatamansi (Jatamanshi) and 300-900 mg of Hypericum perforatum (Basant), with or without known additives calcium sulphate. 8. A herbal composition for management of perimenopausal syndrome and a process for the preparation thereof substantially as herein described.

Documents:

714-del-2002-abstract.pdf

714-del-2002-claims.pdf

714-del-2002-correspondence-others.pdf

714-del-2002-correspondence-po.pdf

714-del-2002-description (complete).pdf

714-del-2002-form-1.pdf

714-DEL-2002-Form-15-(16-06-2010).pdf

714-del-2002-form-18.pdf

714-del-2002-form-2.pdf

714-del-2002-form-3.pdf

714-del-2002-form-4.pdf

714-del-2002-form-5.pdf

714-del-2002-gpa.pdf

714-del-2002-petition-137.pdf

714-del-2002-petition-others.pdf