Claims:I/We, Claim,
1. A nutraceutical formulation comprising of the combination of extracts from the following herbs:
a. Asparagus racemosus,
b. Camellia sinensis (Chaha),
c. Dacus carota (Gajar)and
d. Piperine from Piper nigrum (Marica)
2. A nutraceutical herbal formulation as claimed in claim 1 effectively manages the polycystic ovarian syndrome (PCOS) in women.
3. A nutraceutical formulation as claimed in claim 1 is a health supplement in an ingestible form.

4. The health supplement as claimed in claim 2 comprising the nutraceutical composition claimed in claim 1; wherein the ingestible form is selected from a powder, capsule, tablet, syrup, granules, gel, spray or beverage.
, Description:1. PREAMBLE TO THE DESCRIPTION
1. The following complete specification particularly describes the invention and the manner in which it is to be performed:
“HERBAL FORMULATION FOR MANAGEMENT OF POLYCYSTIC OVARIAN SYNDROME (PCOS)”
2. TECHNICAL FIELD
2. The present invention relates to the field of herbal formulation and composition; more particularly health and wellness supplements. The present invention facilitates the effective management of polycystic ovarian syndrome (PCOS).
3.2. BACKGROUND OF THE INVENTION
3. Women's health issues have attained higher international visibility and renewed political commitment in recent decades. The health of families and communities are tied to the health of women. The illness or death of a woman has serious and far-reaching consequences on the health of her children, family and community.
4. Every year, about 10 million women endure life-threatening complications during pregnancy and childbirth, often leading to long term disability and other problems such as mental health disorders, like depression and anxiety, obesity, heart disease, high blood pressure, abnormal heart beats, menstrual problems, acne and other skin problems. Environmental factors are obesity, sedentary life style, fast food habits, stress factors and viral infections.
5. Polycystic ovary syndrome (PCOS) is one of the most common female endocrine disorders affecting approximately 5%-10% of women of reproductive age (12–45 years old) and is thought to be one of the leading causes of female infertility. The major symptoms for the polycystic ovary syndrome [PCOS] are obesity, anovulation (resulting in irregular menstruation) or amenorrhea, acne, and excessive amounts or effects of androgenic (masculinizing) hormones. The symptoms and severity of the syndrome vary greatly among women. While the causes are unknown, insulin resistance, diabetes, and obesity are all strongly correlated with PCOS.

6. PCOS now affects 1 in 10 women in our country. Women with PCOS usually have irregular menstruation accompanied with anovulation that may result in infertility. Chronic anovulation is a common cause of female infertility.
7. Most of the prior art products are not accurate in results. They are very expensive and difficult to attain results. Moreover, they do not aim at normalizing the hormonal imbalance and further fail to strengthen the uterus.
8. Based on the foregoing, it is believed that a need exists for a novel nutraceutical composition to improve the hormonal imbalance of polycystic ovarian syndrome [PCOS] patients. A need also exists for an antioxidant herbal supplement for polycystic ovarian syndrome [PCOS] patients. Hence, a product for the improvement of hormonal imbalance and supplement for strengthening the uterus of the polycystic ovarian syndrome [PCOS] patients has been invented, which is described in detail below.
9. The herbs Asparagus racemosus, Camellia sinensis (Chaha), Daucus carota (Gajar) and Piperine from Piper nigrum (Marica) with the combination of natural antioxidants and phytoestrogens are combined together for a novel formulation.
3.3 PRIOR ART
10. EP1523325B1: The present invention relates to methods of treating polycystic ovary syndrome (PCOS) comprising administering glucagon-like peptide-1 (GLP-1) to subjects suffering therefrom.

11. IN202141012333: A METFORMIN VAGINAL COMPOSITION FOR POLYCYSTIC OVARIAN SYNDROME : Present invention relates to a novel drug delivery system for metformin through vaginal route. Metformin is first line drug in treatment of PCOS and specifically in obese patients and is effective in treatment to induce ovulation. Metformin HCl is associated with impaired bioavailability (50–60%), lactic acidosis and frequent oral dosing (500 mg 2–3 times a day) in PCOS that ultimately influence the patient compliance. Metformin has dose dependent side effects such as gastrointestinal symptoms of nausea, diarrhea, bloating, anorexia, abdominal pain etc. Current invention provides a composition of metformin hydrochloride in micro emulsion that decreases the dose thereby lowering side effects. It showed more than 90% drug diffusion in the in vitro and ex vivo drug diffusion studies. Further, current inventions provide the Metformin micro emulsions separately amalgamated with a gel for the treatment of PCOS. It increases the retention of micro emulsion formulation in vaginal cavity.
12. IN202111010427 : AN ORAL POLYHERBAL FIXED DOSE FORMULATION FOR PRE-MENSTRUAL SYNDROME AND PROCESS THEREOF : Accordingly, an oral polyherbal dose formulation for pre-menstrual syndrome and process thereof” Accordingly, an oral polyherbal fixed dose formulation for pre-menstrual syndrome and process thereof is disclosed. The oral polyherbal fixed dose formulation of the present invention provides an anti-infective, astringent, anti-inflammatory, antispasmodic, diuretic actions with supplementation of micro-nutrients and reduces anxiety and breast tenderness. The oral polyherbal fixed dose formulation for pre-menstrual syndrome comprising of; active ingredients like 75 mg of Chamomile flower; 100 mg of Chaste berry fruit extract; 75 mg of Fenugreek seed extract; 75 mg of Ginger juice powder; 5 mg of Black cohosh root extract; 200 mg of Myo-inositol; 150mcg of Vitamin B1; and 200mcg of Vitamin B6 respectively and excipients (binding agent). The present invention relates to a poly herbal formulation for Pre-menstrual syndrome. More particularly, the present invention relates to an oral poly herbal fixed dose formulation for premenstrual syndrome and process thereof for relaxation of the muscles during menstruation and for increasing the blood circulation to uterine wall and comfort during menstruation. The present invention is helpful in relief from cramps or pain associated during menstruation mainly for Primary dysmenorrhea and pre-menstrual syndromes. The polyherbal fixed dose formulation is effective for irregular menstrual cycle resulting from the synergy of this composition.
13. 202141005476 - THERAPY FOR TREATMENT OF POLY CYSTIC OVARIAN SYNDROME USING HIBISCUS CANNABINUS LEAF EXTARCT : The present invention relates to the protective effect of Hibiscus cannabinus leaf extract in letrozole induced experimental model of PCOS. Letrozole at a dose of (1 mg/kg) for 21 days increased insulin levels, lipid profile, C-reactive protein, calcium levels, testosterone, LH, FSH levels. Daily treatment with Hibiscus cannabinus at a dose of (200 mg and 400 mg/kg, p.o) for 14 days protected at the microscopic level, markedly restores lipid profile, insulin, calcium, C-reactive protein, luteinizing hormone, follicle stimulating hormone, testosterone levels and biochemical alterations.
4. TECHNICAL PROBLEM TO BE SOLVED
14. Polycystic ovary syndrome [PCOS] is one of the most common female endocrine disorders. Globally PCOS affects between 5% to 10% of women of reproductive age. It not only affects reproductive health but also causes mood and metabolic disorders. The multiple abnormalities associated with PCOS cannot be treated with a single drug or supplement formula effectively. It requires a comprehensive natural formula supporting all aspects of the clinical condition, such as hormonal imbalance, oxidative stress and mental strength. The present invention is polyherbal formula with an ideal combination of phytoesterogens to support hormonal imbalance, natural antioxidants to reduce oxidative stress and improve mental health.

5. SUMMARY OF THE INVENTION
15. The following summary is provided to facilitate an understanding of some of the innovative features unique to the disclosed embodiment and is not intended to be a full description. A full appreciation of the various aspects of the embodiment disclosed herein can be gained by taking the entire specification, claims and abstract as a whole.
16. The prior arts are insufficiently suited for effective management of poly cystic ovarian syndrome (PCOS). It is, therefore, one aspect of the present invention is to provide a novel polyherbal formulation that effectively manages poly cystic ovarian syndrome (PCOS).
17. It is one aspect of the disclosed embodiments to provide antioxidant support to the polycystic ovarian syndrome [PCOS] patients and thereby control oxidative stress in polycystic ovarian syndrome [PCOS] patients.

18. It is another aspect of the disclosed embodiments to provide for an invention for the prevention of the metabolic disorders associated with PCOS.
19. Yet another aspect of the disclosed embodiment is to produce an herbal nutraceutical formulation to improve the blood circulation of the polycystic ovarian syndrome [PCOS] patients.
20. Yet another aspect of the disclosed embodiment is to produce an herbal nutraceutical formulation to reduce cholesterol level of the polycystic ovarian syndrome [PCOS] patients.
21. Yet another aspect of the disclosed embodiment is to produce an herbal nutraceutical formulation which helps to strengthen uterus and relieve menstrual problems thereby reduce the polycystic ovarian syndrome [PCOS].
22. Yet another aspect of the disclosed embodiment is to reduce female infertility caused due to polycystic ovarian syndrome [PCOS] in women.
23. Yet another aspect of the disclosed embodiment is to produce a nutraceutical composition to improve the blood circulation of the polycystic ovarian syndrome [PCOS] patients.
24. Yet another object of the invention is to be efficient, a one stop solution to keep the uterus healthy and to remain as cost efficient as possible.
25. Still another aspect of the disclosed embodiments is to be target specific and increases overall health of the uterus of a patient suffering from polycystic ovarian syndrome [PCOS].
26. The aforementioned aspects and other objectives can be achieved by combining the extracts of the following three herbs in an appropriate proportion as described in the detailed description.
1. Asparagus racemosus (Shatavari)
2. Camellia sinensis (Chaha),
3. Daucus carota (Gajar) and
4. Piperine from Piper nigrum (Marica)
7. DETAILED DESCRIPTION
27. The present invention provides for the unique composition that effectively manages polycystic ovarian syndrome [PCOS] in women with following four herbs namely Asparagus racemosus, Camellia sinensis (Chaha), Daucus carota (Gajar) and Piperine from Piper nigrum (Marica).
28. ASPARAGUS RACEMOSUS : Asparagus racemosa (Shatavari) has been studied having active phytochemicals which may mimic or act as precursors to sex hormones, which are known as “phyto-estrogens”. They act as selective Estrogen Receptor Modulators (SERMs). The diverse biological activity of phytoestrogens is due in part to act estrogenically as estrogen agonists and anti-estrogenically as antagonists.
29. Asparagus racemosus is a total pure herbal extract which actually considered being the most helpful herb for women as it overall helps in balancing the female hormonal system and also cleanses the blood. Asparagus racemosus, which is also known as “Shatavari” which is a climbing plant which, grows in low jungle areas throughout India. This sweet and bitter herb is best known in Ayurveda as a female rejuvenate. Shatavari has been renowned for centuries in India for its therapeutic value in treating female reproductive disorders including infertility, decreased libido, threatened miscarriage, menopause, leucorrhea and cervical pH imbalance. In India, Shatavari is considered the women's equivalent to Ashwagandha, or “Indian Ginseng.” Shatavari’s benefits are not exclusive to womens’ health, however; the herb is also effective treating male impotence and general sexual debility.
30. Asparagus racemosus is considered the best friend of women’s health due to the following reasons. Asparagus racemosus is capable of curing all problems related to female reproductive system. It minimizes the complications related to menstrual cycles including pain, loss of blood and other fluids during menstrual cycle. It balances the female hormonal system. It helps in reducing inflammation of female sexual organs. It cures tiredness and morning sickness. It is useful in issues related to infertility, leucorrhea, and in regulating ovulation which occurs during the menopause cycle. It gives stamina for women and supplies natural calcium for women health.
31. Chemical Composition of Asparagus racemosus: Steroidal saponins and sapogenins are believed to account for Shatavari’s medicinal potency. These chemicals include a unique group known as Shatavarins I-IV, ß-D-Glc-(1-4)-ß-D-Glc-(1-2) sarasapogenin, arasosapogenin. Sterols and diosgenin have also been isolated from Shatavari’s roots.
32. Additional chemical constituents include the alkaloid Asparagamine A, isolated from the plant’s roots. Ripe fruits from Shatavari have yielded the flavonoids quercetin, rutin, hyperoside, cyanidin-3-galactoside and cyanidin-3-glucorhamnoside. Quercetin-3-glucuronide has also been isolated from Shatavari’s leaves.
33. It provides bioflavonoids, glucosides, tannins & essential vitamins essential to strengthen women health & helps to improve the anabolic activities of the body. These compounds have been reported to have different beneficial biological roles in women’s health, thus enabling potential application in women health supplementation.
34. Galactogogue activity of Asparagus racemosus has been studied. Saponin mixture from total alcoholic extract of Shatavari was found to show uterine blocking activity, both spontaneous and induced by acetylcholine and oxytocin.
35. The major properties of Asparagus racemosus are:
a. Treating ULCER:
Asparagus racemosus may prolong the life span of mucosal cells, increase the secretion and viscosity of mucus and strengthen the mucosal barrier and thus reduces H+ ion back diffusion into the mucosa. It forms a complex with mucus of other substances at the base of ulcer which may protect the ulcer from the corrosive and proteolytic effects of acid-pepsin. It also has cytoprotective action like that of prostaglandins.
b. Regulate Menstrual Cycle:
The phytoestrogens content present in Asparagus racemosus helps to maintain endogenous harmony, supports and regulates hormonal secretions. Helps to regulate HPO axis hence regularizes menstrual cycle.
c. Promotes Ovulation and benefits infertility:
Helps to regularize the hormonal balance, promotes ovulation and tones the endometrium for better nidation of the zygote.
1. Restores Ovarian Functions,
2. Improves Menstrual Pattern,
3. Increases the level of SHBG and
4. Prevents stress-induced disturbances.

d. Enhance the thickness of Endometrium:
Due to the phytoestrogenic & phytoprogesterogenic effects of Asparagus racemosus helps to enhance the thickness of the endometrium to the desirable levels.
e. Treats and prevents recurrence of Vaginitis and Leucorrhoea:
Asparagus racemosus exerts anti-infective action against wide range of microbes, so it helps to reduces discharge and raises the immunity power in the body thus prevents recurrence.
f. Hormonal balance:
Asparagus racemosus herb helps to restore the hormonal balance in the body. Helps to prevent disturbances in HPO axis, helps to improves endurance level in conditions of stress, thus restoring the normal physiology of female.

i. Immunomodulator [effect on immune system]:
Asparagus racemosus has a special immunomodulator effect on the immune system. It has an immunostimulant effect.
36. It acts effective towards Galactagogue [Production of Milk], Aphrodisiac [Sexual Tonic], Diuretic [Anything that promotes the formation of urine by the kidney], Nutritive Tonic, Demulcent [Relieving pain], Antispasmodic [Herb that suppresses muscle spasms], Adaptogen [Body resistance to stress], Anti-tussive [Treatment with cough suppressants], Antioxidant, Antibacterial, Cytoprotective [Protecting cells from noxious chemicals or other stimuli], Anti-Oxytocic, Anti-diarrhoeal, It prevents post-operative adhesions.
37. Camellia sinensis : The Green tea is obtained from tea plant Camellia sinensis which belongs to the Theaceae family. It is a widely used medicinal plant by the tribals throughout India and China. Green tea is a popular medicinal plant in various indigenous system of medicine like Ayurveda, Unani and Homoeopathy. Camellia sinensis grown in India in states like Assam, Kerala, Karnataka, Tamil Nadu, West Bengal, Sikkim, Himachal Pradesh, Tripura, Uttar Pradesh and Manipur.
38. The major properties of Camellia sinensis are:
a. Improves Mood :
L-theanine present in Camellia sinensis, enhanced alpha brain wave activity and increased synthesis of GABA in turn produce in the brain and increase secretion of dopamine and serotonin. L-theanine helps to reduce stress, depression, improves mood and promotes sleep.
b. Reduce Body Weight :
The green tea polyphenols activate AMPK which would decrease gluconeogenesis and fatty acid synthesis and increase catabolism, leading to body weight reduction. The green tea polyphenols improve the insulin sensitivity, helps to reduce blood sugar level.
c. Follicular Development
Green tea polyphenols possess antioxidant activity and able to modulate the gonadotropin levels like Follicle-stimulating hormone (FSH) which stimulate the growth of ovarian follicles in ovary.
d. Prevents Ovarian Cancer
The green tea possesses antioxidant and anti-inflammatory property reduce oxidative stress and proinflammatory cytokines such as IL-6, CCL2/MCP-1, and TNF-α. Which helps to reduce the occurrence of ovarian cancer and progression of ovarian cancer.
39. Piperine
The major properties of Piperine are:
a. Reduce Depression
Piperine is a potent monoamine oxidase inhibitor (MAOI) which boost serotonin, dopamine and norepinephrine levels in the brain and decreasing anxiety and depression, improving mood and memory.

b. Improves Insulin Sensitivity and Fat Burn
Piperine interacts with AMP-activated protein kinase (AMPK) which improves metabolic process. Thus, increase insulin sensitivity and reduce cholesterol and glucose in body.
c. Anti-oxidant Property
Piperine suppresses the accumulation of lipid peroxidation products, enhances the activity of anti-oxidant enzymes. It significantly reduced the levels of pro-inflammatory mediators such as IL-1β, TNF-α and PGE2 and increased level of IL-10. The anti-oxidant and anti-inflammatory property. The antioxidant property of piperine protects liver, kidney, prevent cancer occurrence and protects cartilage by reducing inflammation.
d. Bioavailability Enhancer
The piperine act as bio enhancement property which helps to absorb nutrients in intestine such as vitamins, minerals. etc.

40. Beta carotene (From Daucus carota)
The major properties of Beta carotene are:
a. Protect Bone Health
The beta carotene is reduced oxidative stress in bones, attenuates bone loss by reducing bone mineral density (BMD) and increases the expression of Osteoprotegerin (OPG) in the bone marrow cells which leads to strengthen the bones.
b. Shorter time to Pregnancy
The clinical studies suggest that beta carotene helps to treat unexplained infertility problems. The studies suggest that it makes shorter time to pregnancy with women of different age groups.
c. Reduce Obesity
Beta-carotene has decreases obesity by promoting fatty acid oxidation in body tissues and lover the cholesterol in blood.

d. Menorrhagia
Beta carotene is metabolized in liver in to vitamin A. In a clinical study woman with menorrhagia due to various causes take Vitamin A as supplement for 30 days. The study results that vitamin A aids to normalize the menorrhagia.