A nutraceutical formulation to treat hormonal imbalances and menstrual disorders

Abstract

Disclosure of a nutritional formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the nutritional formulation includes a phytonutrient and a micronutrient. The phytonutrient is chosen from Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), gingko biloba or extract of dried leaf of Gingko Biloba, and combinations thereof. Disclosure of a nutritional formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the nutritional formulation includes a phytonutrient and a micronutrient and further including an antioxidant and another ingredient, wherein the phytonutrient comprises Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of ashwagandha (Withania somnifera), and Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca). Disclosure of a nutritional formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the menstrual cycle disorder is perimenopause or early menopause.

Description

A NUTRACEUTICAL FORMULATION TO TREAT HORMONAL IMBALANCES AND MENSTRUAL DISORDERS PRIORITY APPLICATION DETAILS

[0001] The present application claims the priority from the Indian provisional patent application number 202321087047 dated December 20, 2023, having a title as- A NUTRACEUTICAL FORMULATION TO TREAT HORMONE IMBALANCES AND THE VARIOUS AILMENTS LIKE MENSTRUAL DISORDERS THEREOF. TECHNICAL FIELD

[0002] This disclosure relates to nutraceutical formulations and the treatment methods thereof for effective management of hormonal imbalance responsible for menstrual cycle and related disorders associated thereof such as irregular menstrual cycles, menopause, endometriosis, fibroids, adenomyosis, breast cancer and other estrogen related cancers like cervical, uterine and ovarian cancers among others. BACKGROUND OF THE INVENTION

[0003] In this section, we discuss several aspects of related work, including background and conventional technologies.

[0004] The menstrual cycle is a natural part of a woman's life. Women's menstruation health is directly related to their health conditions. Menstruation is a normal and healthy part of life for most women. Amidst women about 26 per cent of the global population are of reproductive age who essentially require healthy menstrual health which in fact is an important factor for physical, mental, and social well-being and not merely the infirmity in relation to the menstrual cycle. Traditional medicines of mostethnic groups have contributed to women's health care and treatment of gynecological diseases.

[0005] The menstrual cycle is the time considered from the first day of a woman's period to the day before her next period. The length of the menstrual cycle varies from woman to woman, but the average is to have periods every 28 days. Regular cycles that are longer or shorter than this, from 21 to 35 days, are considered to be normal. In many cases it has been seen that women have periods that have a standard or perfect timing. However, some women may have extremely unpredictable or irregular periods. There are numerous reasons that can cause irregular periods and one prime reason is hormonal imbalance.

[0006] Literature reviews were performed using Google Scholar, PubMed, Science Direct, Web of Science and the keywords "menstruation," "amenorrhea," "arrested menstruation," "obstructed menses," "emmenagogue," "dysmenorrhea," "menses pain," "menstrual pain," "menstrual cramps," "menstrual colic," "excessive menses," "excessive menstruation," "menorrhagia," "hypomenorrhea," "oligomenorrhea," "scanty menses," "premenstrual syndrome," "menstrual disorders," "menses disturbance," "abnormal menstruation," "irregular menses" and "metrorrhagia" in combination with "herbs," "medicinal plants" and "Africa," "Asia," "Latin America," "Oceania," "Europe" or specific countries in these geographical areas.

[0007] A literature survey and internet screening revealed that nutraceutical formulation comprising a proper combination of said natural phytonutrients, isoflavones, antioxidants, micronutrients and organic calcium has not yet been disclosed to provide adequate health protective benefits to women facing the problems like menstrual cycle and the associated disorders thereof.

[0008] In view of above it was evident that there is no disclosure nor a product based on nutraceutical composition to address the hormonal imbalance related menstrual cycle issues in the women.

[0009] Menstrual Disorders like Dysmenorrhea lead to painful cramps during menstruation, Premenstrual syndrome (PMS) leads to physical and psychological symptoms occurring prior to menstruation, Menorrhagia is heavy bleeding, including prolonged menstrual periods or excessive bleeding during a normal-length period, Metrorrhagia is bleeding at irregular intervals, particularly between expected menstrual periods, Amenorrhea is the absence of menstruation, Oligomenorrhea is infrequent menstrual periods, Hypomenorrhea is light periods, Endometriosis and Fibroids. Irregular menstruation also includes: Periods those occur fewer than 21 days or more than 35 days apart. Missing three or more periods in a row. Menstrual flow (bleeding) that's much heavier or lighter than usual. Periods that last longer than seven days. Length of time between cycles varies by more than nine days. For example, one cycle is 28 days, the next is 37 days and the next is 29 days. Periods those are accompanied by severe pain, cramping, nausea or vomiting. Bleeding or spotting that happens between periods, after menopause or after sexual intercourse. Soaking through one or more tampons or sanitary pads in an hour.

[0010] Phytonutrients are used in the treatment are directed towards eradicating the underlying causes like ovulation disorder, premature ovarian failure (POF), blocked fallopian tubes, adhesions (scar tissue) and pelvic inflammatory disease. The most commonly known and used phytonutrients such as Ashwagandha (Withania somnifera), Shatavari (Asparagus racemousus), GingKo Biloba, Amalaki (Emblicaofficinalis), Dashmoola, Guduchi, Jeevanti and Punarnava are known to maintain the hormonal balance between the Follicle Stimulating Hormone (FSH) and the Luteinizing Hormone (LH). Natural products or phytonutrients used in the treatment of ovulation disorder include Ashoka, Dashmoola, Shatavari, Aloe vera, Guggulu etc. Premature ovarian failure (POF) is treated with Ashoka, Dashmoola, Shatavari, Guduchi, Jeevanti etc. Blocked fallopian tubes, adhesions (scar tissue) and pelvic inflammatory disease is treated with Guduchi, Punarnava etc.

[0011] Ashwagandha called the king of Ayurvedic herbs is best known for reducing stress and anxiety. Evergreen Herb Shatavari capsules are known to support in regulating the menstrual cycle and can help in providing relief from the symptoms of premenstrual syndrome (PMS) and menstrual cramps. It also helps in case of abnormal or prolonged bleeding. Shatavari is known to stimulate ovulation and help improve female fertility. It increases libido, cures inflammation of sexual organs, helps treat PCOD, prepares the uterus for conception, prevents miscarriages, good postpartum tonic, improves lactation, helps in menstrual disorders.

[0012] Ginkgo biloba helps in managing menstrual cramps because it relieves congestive symptoms such as breast tenderness and the cramping due to inflammation. A study published in the August 2009 issue of the "Journal of Alternative and Complementary Medicine" investigated the benefits of ginkgo biloba for women with dysmenorrhea (painful cramp during the periods) or menstrual cramping, as well as premenstrual syndrome and pain. In the study, participants who took ginkgo biloba supplements three times daily from the 16th day of their menstrual cycle until the fifth day of the next cycle reported relief of their cramps. This was a single-blind,randomized, placebo-controlled trial of 85 medical university students. After the ginkgo intervention, there was a significant decrease in the overall severity of painful cramping in the ginkgo biloba test group versus the placebo. This study indicates that Ginkgo biloba successfully manages menstrual cramp which is one of the disorders associated with menstrual cycle. Ginkgo biloba is responsible for curing only menstrual cramps with success rate of about 15% in 3 months when used alone.

[0013] The seeds bark and flowers of Ashoka are mainly used for in menorrhagia (heavy bleeding, including prolonged menstrual periods or excessive bleeding during a normal-length period), and can also be used as uterine stimulant, estrogenic effects. However, the drawback associated with Ashoka is that it may act as an abortifacient (that induces abortion) hence the quantification of all the phytonutrients becomes major and important criteria of the study. When Ashoka used alone the success rate is less than 10% during 3 months usage.

[0014] DISADVANTAGES ASSOCIATED WITH IRREGULAR MENSTRUAL CYCLE i. An irregular cycle can also make it more difficult to get pregnancy naturally, particularly in case no ovulation takes place each month. ii. Women with irregular menstrual cycles may have a double danger of ovarian cancer as compared to the women who have standard month-to-month period cycles. iii. Irregular periods can result in a thick coating of the uterus, which can be a hazard for creating uterine cancer. An irregular period is when the length of menstrual cycle unexpectedly falls outside of your regular range. iv. Irregular periods can include abnormal uterine bleeding.iv. Irregular periods that are with very heavy, can result in issues like a low blood count, low blood pressure, weakness or anaemia. v. If irregular periods are consistent, it needs to be assessed for polycystic ovary syndrome (PCOS). PCOS influences up to 10 percent of the women who are in their conceiving age. Apart from causing infertility, PCOS can expand the danger of diabetes and many heart diseases. vi. Irregular periods can give rise to the disorder like thyroid related problems (over active or under reactive thyroid) can aggravate ovulation, which may cause a lot of hormone imbalance in women's body.

[0015] The problem of menstrual cycle is fairly common now a days and it has become need of the hour to find out solution which is having less complications & affordable. The key factor is to keep menstrual cycles consistent in length from month to month to maintain women health in many aspects.

[0016] There is no indication or teaching that the phytonutrients namely, Shatavari, Ashwagandha, Ashok and Ginkgo biloba with or without Black cohosh (Actaea racemose), Isoflavones, antioxidants and Micronutrients be used in a single formulation product for any biological activity particularly for females. None of the literature surveyed provides compositions that combine these ingredients in appropriate proportions that resulted in improved menstrual cycle and other associated disorders thereby improving womens health.

[0017] It would be desirable to provide a fruitful and healthy solution to menstrual- related discomforts, disorders and to improve consequences for mental well-being, and prevent social exclusion.SUMMARY OF THE INVENTION

[0018] Disclosed nutraceutical formulation for treating hormonal imbalance related ailments like irregular menstrual cycle, Menopause, Endometriosis, fibroids, adenomyosis, breast cancer and other estrogen related cancers like cervical, uterine & ovarian cancers) in women. Nutraceutical formulation and the process thereof of the present invention comprises a variety of phytonutrients, isoflavones, antioxidants , other ingredients and micronutrients which are dialectical in compatibility and are useful in treating both the symptoms and the causes adhered to realize deep lesions treatment so that hormonal imbalance related disorder as disclosed herein before and after are treated effectively. A combination of several substances like phytonutrients, micronutrients, antioxidants, other ingredients and isoflavones exhibits a synergistic effect resulting in unexpected benefits due to the synergistic nature of the ingredients involved therein. Known compositions comprising Shatavari, Ashwagandha and Ashoka and other ayurvedic herbs cures menstrual cycle related symptoms within 3- 5% of the patients in 3 months period. However, the composition of this invention comprising phytonutrients, micronutrients, antioxidants, other ingredients and isoflavones as disclosed herein cures hormonal imbalance related symptoms as disclosed herein up to about 70% of patients within 3 months treatment. Disclosed teachings provide a nutraceutical formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the nutraceutical formulation comprises a phytonutrient and a micronutrient, wherein the phytonutrient is chosen from Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), gingko biloba or extract of dried leaf of Gingko Biloba, and combinations thereof, wherein the menstrual cycle disorder is chosen from premenstrual syndrome, hypomenorrhea, dysmenorrhea, amenhorrhea, oligomenorrhea, and menorraghia.

[0019] Disclosed teachings provide a nutraceutical formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the nutraceutical formulation comprises a phytonutrient and a micronutrient, wherein the phytonutrient is selected from the group consisting of Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), gingko biloba or extract of dried leaf Gingko Biloba, and combinations thereof, wherein the menstrual cycle disorder is chosen from premenstrual syndrome, hypomenorrhea, dysmenorrhea, amenohorrhea, and oligomenorrhea.

[0020] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of comprising: Shatavari (Asparagus racemosus) ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg: extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg; and, extract of dried leaf Gingko biloba ranging from about 50 mg to about 200 mg in 5 grams of a composition comprising the nutraceutical formulation.

[0021] Disclosed teachings provide a nutraceutical formulation for the menstruation- related hormonal imbalance comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca); and, about 200 mg of extract of dried leaf of Gingko biloba in 5 grams of a composition comprising the nutraceutical formulation.

[0022] Disclosed teachings provide a nutraceutical formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the nutraceutical formulation comprises a phytonutrient and a micronutrient, wherein the phytonutrient comprises Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of Ashoka (Saraca asoca), and wherein the menstrual cycle disorder is menorraghia.

[0023] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of comprising: Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg: extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg; in 5 grams of a composition comprising the nutraceutical formulation.

[0024] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca); and, in 5 grams of a composition comprising the nutraceutical formulation.

[0025] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder, wherein the nutraceutical formulation further includes a phytoesterogen, wherein the phytoestrogen chosen from black cohosh and soya isofavones, and wherein the menstrual cycle disorder is perimenopause or early menopause.

[0026] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of comprising: Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg; extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg; extract of dried leaf of Gingko biloba ranging from about 50 mg to about 200 mg; Black cohosh ranging from about 50 mg to about 200 mg; and Soya Isoflavones (extracted from soya beans) ranging from about 10 mg to about 100 mg in 5 grams of a composition comprising the nutraceutical formulation.

[0027] Disclosure provides a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca); about 120 mg of extract of dried leaf of Gingko biloba; about 100 mg of Black cohosh; and about 50 mg of Soya Isoflavones in 5 grams of a composition comprising the nutraceutical formulation.

[0028] Disclosure provides a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of further comprising an antioxidant and an other ingredient.

[0029] Disclosure provides a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder, wherein the phytonutrient comprises Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of ashwagandha (Withania somnifera), and Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), and wherein the menstrual cycle disorder is selected from the group consisting of endometriosis, fibroid, adenomyosis, breast cancer, an estrogen related cancer, wherein the estrogen related cancer is selected from the group consisting of cervical cancer, uterine cancer, ovarian cancer and combinations thereof.

[0030] Disclosure provides a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder comprising: Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg; extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg in 5 grams of a composition comprising the nutraceutical formulation.

[0031] Disclosure provides a nutraceutical formulation for treating a hormonal imbalance affecting the menstrual cycle disorder comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca) in 5 grams of a composition comprising the nutraceutical formulation.

[0032] Disclosure provides nutraceutical formulations for treating a hormonal imbalance affecting the menstrual cycle disorder, wherein the antioxidant is selected from the group consisting of glutathione, N-Acetyl Cysteine, extract of Vijaysar (Pterocarous marsupium), resveratrol, pterostilbene, and combinations thereof.

[0033] Disclosure provides nutraceutical formulation for treating a hormonal imbalance affecting the menstrual cycle disorder comprising: Glutathione ranging from about 50 mg to about 200 mg; N-acetyl cysteine ranging from about 50 mg to about 200 mg; and Extract of grape (Vitis) ranging from 40 mg to about 100 mg in 5 grams of a composition comprising the nutraceutical formulation, and wherein the extract of grape (Vitis) comprises about 1% to about 5% of reservatrol.

[0034] Disclosure provides nutraceutical formulations for treating a menstruation- related hormonal imbalance comprising: Glutathione ranging from about 50 mg to about 200 mg; N-acetyl cysteine ranging from about 50 mg to about 200 mg; and extract of vijaysar (Pterocarous marsupium) ranging from 40 mg to about 100 mg in 5 grams of a composition comprising the nutraceutical formulation, and wherein the extract of vijaysar (Pterocarous marsupium) comprises about 1 % to about 5% of pterostilbene.

[0035] Disclosure provides nutraceutical formulations for treating a hormonal imbalance affecting the menstrual cycle disorder, wherein the other ingredient is selected from the group consisting of a Cruciferous vegetable ingredient, a probiotic and a calcium salt, wherein the cruciferous vegetable ingredient is selected from the group consisting of a cruciferous vegetable fibre, an active ingredient of a cruciferous vegetable, a derivative of an active ingredient of a cruciferous vegetable, Diindolylmethane (DIM), Indole-3-Carbinol (I3C), the probiotic is selected from the group consisting of Lactobacillus and Bifido bacterium, and the Calcium salt is selected from the group consisting of Calcium Di-Glucarate, Calcium Gluconate, Calcium Di- Saccharate or combinations thereof.

[0036] Disclosure provides nutraceutical formulations for treating a hormonal imbalance affecting the menstrual cycle disorder comprising: the cruciferous vegetable ingredient ranging from about 100 mg to about 500 mg; the probiotic ranging from about 5 million to about 20 million; and, the calcium salt ranging from about 100 mg to about 500 mg in 5 grams of a composition.

[0037] Disclosure provides nutraceutical formulations for treating a hormonal imbalance affecting the menstrual cycle disorder, wherein the micronutrient is selected from the group consisting of Vitamin C, Calcium carbonate, magnesium sulphate, Zinc Sulphate, Vitamin B5 sodium chloride, potassium chloride, Vitamin B3, vitamin B1, vitamin B2, vitamin B6, ferrous Fumerate, manganese sulphate, Folic acid, Folate, Vit A (acetate), sodium Selenite, Biotin, chromium picolinate, potassium iodide, vitamin B12, L-glutamine, L-Taurine, L-lysine, Vitamin D and combinations thereof.

[0038] A dosage of the disclosed nutraceutical formulations for treating the hormonal imbalance affecting the menstrual cycle disorder is about 5 gm of the nutraceutical formulation per day.

[0039] A dosage form of the nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder is chosen from tablet, capsule, powder and decoction.

[0040] Disclosure provides methods for treating a hormonal imbalance affecting a menstrual cycle disorder. The method comprises administering the nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder to a subject in need thereof, wherein the menstrual cycle disorder is chosen frompremenstrual syndrome, hypomenorrhea, dysmenorrhea, amenorrhea, oligomenorrhea, menorrhagia, perimenopause, early menopause, endometriosis, fibroid, adenomyosis, breast cancer, an estrogen related cancer, and wherein the estrogen related cancer is chosen from cervical cancer, uterine cancer, ovarian cancer or combinations thereof.

[0041] Disclosure provides a method for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein an improvement in pain is observed after 3 months of treatment.

[0042] Disclosure provides a method for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein an improvement in bleeding is observed after 3 months of treatment.

[0043] Disclosure provides methods for regularizing menstrual cycle in terms of intermittent or irregular frequency of periods, duration of menstrual cycle or period, and / or flow of blood in terms of quantity of blood flow and clots in blood. DETAILED DESCRIPTION OF THE INVENTION

[0044] It has been observed by the present inventors, that use of only Shatavari or Shatavari based phytonutritional combinations has a success rate in less than 10% of patients in 3 months trial for treatment of menstrual disorders.

[0045] The disclosure provides treatments for hormonal imbalances by providing an effective novel nutraceutical formulation. To the best of our knowledge, the present nutraceutical formulation is safe, effective and more efficient over the known formulations and has the desired pharmaceutical activity owing to synergistic effect because if used individually the ingredients do not provide the desired pharmaceutical activity.

[0046] To address irregular menstrual cycle and associated disorders and its impact on women health, a few natural plants or trees and some essential herbs have been investigated for their beneficial medicinal properties.

[0047] The problem of menstrual cycle is fairly common now a days and it has become need of the hour to find out solution which is having less complications & affordable. The key factor is to keep menstrual cycles consistent in length from month to month to maintain women health in many aspects.

[0048] There is no indication or teaching that the phytonutrients namely, Shatavari, Ashwagandha, Ashok and Ginkgo biloba with or without Black cohosh (Actaea racemose), Isoflavones, antioxidants and Micronutrients be used in a single formulation product for any biological activity particularly for females. Furthermore literature also doesn’t indicate or teach combining these ingredients with other nutrients in the appropriate proportion which shall result into improved menstrual cycle and other associated disorders thereby improving women health.

[0049] To address the said issue of irregular menstrual cycle and associated disorders, its impact on women health, a few natural plants / trees have been investigated for the beneficial medicinal properties and some essential herbs based on exhaustive R&D without any teaching or motivation from prior art have been identified for the present invention.

[0050] As per the finding of the present inventors, it has been observed that formulation comprising only Shatavari having normal dose less than 1 gm it has been observed that the cure is less than 10% in 3 months.

[0051] Administering formulations having Phytonutrients alone shows almost negligible effects at 3 months of treatment.

[0052] Administering formulations having Micronutrients (multi vitamins) alone or antioxidants alone shows almost negligible effects at 3 months of treatment.

[0053] On the other hand nutraceutical formulation of the present invention comprising the known phytonutrients like Shatavari, Ashwagandha, Ashoka and Ginkgo biloba, Micronutrients (Vitamins), antioxidants with or without Black cohosh (Actaea racemose), Isoflavones and other ingredients in proper proportion. It has been observed by the inventors of the present inventors; that cure is above 70% 90% in clinical study in the time span of 3 months only thereby proving the synergistic effect of ingredients of the disclosed nutraceutical formulations.

[0054] Root cause associated with menstrual cycle and the disorders thereof is due to the Hormone imbalance, micronutrient deficiencies, poor blood flow in uterus, and physical causes like endometriosis, uterine fibroids, and other pelvic diseases. Our modern life-style adversely affects the hypothalamus, a region of the brain, the seat of emotions, which regulates the nervous system and pituitary gland. Imbalance in the regulation of reproductive hormones by the hypothalamus or the pituitary gland or problems in the ovary can cause various menstrual cycle and disorders related thereof. A combination of several substances like phytonutrients, micronutrients, other ingredients, antioxidants and isoflavones resulting in unexpected benefits due to the synergistic nature of the ingredients involved therein.

[0055] The present invention is directed to a novel nutraceutical formulations comprising phytonutrients, micronutrients, antioxidants, other ingredients and isoflavones for addressing and management of irregular menstrual cycle and related disorders thereof thereby improving overall health in women.

[0056] Some embodiments provide nutraceutical formulations useful in the treatment of menstrual cycle and various related disorders thereof.

[0057] In some embodiments the nutraceutical formulation comprises essentially Shatavari (Astragalus), Ashoka, Ashwagandha, Ginkgo biloba with or without Black cohosh, isoflavones, antioxidants, organic calcium and micronutrients.

[0058] In some embodiments nutraceutical formulations are provided and their usefulness in treatment of menstrual cycle and the associated problems thereof.

[0059] Except where otherwise expressly indicated, all numerical quantities in this description are to be understood as modified by the word “approx” in describing the broadest scope of the technology. When describing weight of various ingredients in formulations of the present disclosure, as set forth herein below, the term “about” is hereby defined to mean within plus or minus five weight percent (±5 wt %) by weight relative to a total weight of the formulation. Each of these ingredients may be extracted, powdered or granulated prior to being incorporated into the nutraceutical formulation.

[0060] For example, the natural ingredients may be powdered or granulated to a particle size between about 10 microns and about 300 microns, and more particularly between about 100 microns and about 200 microns. However, one of ordinary skill in the art may select other suitable particle sizes, including particle sizes adapted to facilitate better dispersion of the nutraceutical formulation as described further herein below, as desired. Furthermore, each of these natural ingredients may be substantially evenly mixed together according to conventional techniques to provide the nutraceutical formulation for convenient end use, as described further herein.

[0061] In particular examples, the ingredients are provided in a dosage form suitable for oral administration, including one or more tablets or capsules, decoction, a manufactured or compounded liquid or slurry form, or as a manufactured powder or granulate. In this disclosure useful synergistic properties in a combination of substances which are already known for their health benefits could be found to offervaluable health benefits. More particularly, nutraceutical formulations derived from unknown or known substances is found to be beneficial for women finding the health issues related to hormonal imbalance menstrual cycle and associated problems thereof which were previously unrecognized.

[0062] Synergistic effects of disclosed nutraceutical formulations not only regulates the menstrual cycle but also improves various female related ailments associated with menstrual cycle as listed herein below: Dysmenorrhea - painful cramps during menstruation, Premenstrual syndrome (PMS) - physical and psychological symptoms occurring prior to menstruation, Menorrhagia - heavy bleeding, including prolonged menstrual periods or excessive bleeding during a normal-length period, Metrorrhagia - bleeding at irregular intervals, particularly between expected menstrual periods, Amenorrhea - the absence of menstruation, Oligomenorrhea - infrequent menstrual periods, Hypomenorrhea - light periods, polycystic ovarian syndrome (PCOS), which leads to female sterility, menstrual disorder and obesity. Endometriosis –endometriosis is a disease in which tissue similar to the lining of the uterus grows outside the uterus. It can cause severe pain in the pelvis and make it harder to get pregnant. Endometriosis can start at a person's first menstrual period and last until menopause. Adenomyosis, breast cancer and other Hormone estrogen related cancers like cervical, uterine & ovarian cancersFibroids -fibroids are non-cancerous growths that develop in or around the womb (uterus). The growths are made up of muscle and fibrous tissue, and vary in size. They're sometimes known as uterine myomas or leiomyomas. Many women are unaware they have fibroids because they do not have any symptoms.

[0063] In particular, the present disclosure relates to a synergistic nutraceutical formulation that regulates menstrual cycle and associated problems thereof.

[0064] Nutraceutical formulation of the present invention contain the known phytonutrients like Shatavari, Ashwagandha, Ashoka and Ginkgo biloba. However, there is a need of today to develop a formulation comprising all the herbs as mentioned herein before with or without Black cohosh (Actaea racemose) and Isoflavones, antioxidants, other ingredients and Micronutrients in proper proportion which owing to synergistic effect of combined ingredients into a single formulation is very effective for the treatment of hormonal imbalance causing disturbed menstrual cycle and associated disorders thereof.

[0065] Wherein; Black cohosh (Actaea racemose) is a wood land herb used as medicine and is often used for estrogen-related conditions and vaginal dryness. It is also recognized not just for its fertility benefits, but also for managing painful periods due to its anti-inflammatory properties. However; as per the literature from Goggle it has been known that black cohosh might increase or decrease the effects of estrogen in some parts of the body.

[0066] Isoflavones are ranked among the most estrogenic compounds. The main source of isoflavones are legumes from the family Fabaceae namely soybean (Glycine max) and the like.

[0067] Micronutrients are often referred to as vitamins and minerals, are vital to healthy development, disease prevention, and wellbeing. With the exception of vitamin D, micronutrients are not produced in the body and must be derived from the diet.

[0068] Antioxidants are man-made or natural substances that may prevent or delay some types of cell damage. Antioxidants are found in many foods, including fruits and vegetables. They are also available as dietary supplements. Antioxidants are electron donors which neutralize free radicles which often cause harm to body cells, tissues and DNA.

[0069] Other ingredients are Cruciferous vegetable Fibres or its active ingredients / derivatives like Diindolylmethane (DIM), Indole-3-Carbinol(I3C) which promotes healthy estrogen metabolism, Probiotics like Lactobacillus, Bifido bacterium and the likes responsible for detoxification and Calcium salts like Calcium Di- Glucarate, Calcium Gluconate, Calcium Di-Saccharate and the likes which act as chelating agent.Disclosure provides nutraceutical formulations having phytonutrients like Shatavari, Ashwagandha, Ashoka and Ginkgo biloba, Micronutrients (Vitamins), antioxidants with or without Black cohosh (Actaea racemose), Isoflavones and other ingredients in proper proportion. It has been observed that cure is above 70% in clinical study in the time span of 3 months only thereby proving the synergistic effect of ingredients of the nutraceutical formulation. Whereas formulations comprising only Shatavari having normal dose less than 1 gm resulted in cure of less than 10% in 3 months. Cure by other formulation having only individual phytonutrients or micronutrients (multi vitamins) or antioxidants is almost negligible at 3 months.

[0070] Disclosed nutraceutical formulations include phytonutrients like Shatavari, Ashwagandha, Ashoka and Ginkgo biloba. However, there is a need of today to develop a formulation comprising all the herbs as mentioned herein before with or without Black cohosh (Actaea racemose) and Isoflavones, antioxidants, otheringredients and Micronutrients in proper proportion which owing to synergistic effect of combined ingredients into a single formulation is very effective for the treatment of hormonal imbalance causing disturbed menstrual cycle and associated disorders thereof.

[0071] Wherein; Black cohosh (Actaea racemose) is a wood land herb used as medicine and is often used for estrogen-related conditions and vaginal dryness. It is also recognized not just for its fertility benefits, but also for managing painful periods due to its anti-inflammatory properties. However, black cohosh might increase or decrease the effects of estrogen in some parts of the body.

[0072] Isoflavones are ranked among the most estrogenic compounds. The main source of isoflavones are legumes from the family Fabaceae namely soybean (Glycine max) and the like.

[0073] Micronutrients are often referred to as vitamins and minerals, are vital to healthy development, disease prevention, and wellbeing. With the exception of vitamin D, micronutrients are not produced in the body and must be derived from the diet.

[0074] Antioxidants are man-made or natural substances that may prevent or delay some types of cell damage. Antioxidants are found in many foods, including fruits and vegetables. They are also available as dietary supplements. Antioxidants are electron donors which neutralize free radicles which often cause harm to body cells, tissues and DNA.

[0075] Other ingredients are Cruciferous vegetable fibers or active ingredients or derivatives from them like Diindolylmethane (DIM), Indole-3-Carbinol(I3C) which promotes healthy estrogen metabolism, Probiotics such as Lactobacillus, Bifido bacterium and others responsible for detoxification and Calcium salts like Calcium Di-Glucarate, Calcium Gluconate, Calcium Di-Saccharate and others which act as chelating agent.

[0076] Disclosed teachings provide a nutraceutical formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the nutraceutical formulation comprises a phytonutrient and a micronutrient, wherein the phytonutrient is chosen from Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), gingko biloba or extract of dried leaf of Gingko Biloba, and combinations thereof, wherein the menstrual cycle disorder is chosen from premenstrual syndrome, hypomenorrhea, dysmenorrhea, amenhorrhea, oligomenorrhea, and menorraghia.

[0077] Disclosed teachings provide a nutraceutical formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the nutraceutical formulation comprises a phytonutrient and a micronutrient, wherein the phytonutrient is selected from the group consisting of Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), gingko biloba or extract of dried leaf Gingko Biloba, and combinations thereof, wherein the menstrual cycle disorder is chosen from premenstrual syndrome, hypomenorrhea, dysmenorrhea, amenohorrhea, and oligomenorrhea.

[0078] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of comprising: Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg;extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg: extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg; and, extract of dried leaf Gingko biloba ranging from about 50 mg to about 200 mg in 5 grams of a composition comprising the nutraceutical formulation.

[0079] Disclosed teachings provide a nutraceutical formulation for the menstruation- related hormonal imbalance comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca); and, about 200 mg of extract of dried leaf of Gingko biloba in 5 grams of a composition comprising the nutraceutical formulation.

[0080] Disclosed teachings provide a nutraceutical formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the nutraceutical formulation comprises a phytonutrient and a micronutrient, wherein the phytonutrient comprises Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of Ashoka (Saraca asoca), and wherein the menstrual cycle disorder is menorraghia.

[0081] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of comprising:Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg: extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg; in 5 grams of a composition comprising the nutraceutical formulation.

[0082] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca); and, in 5 grams of a composition comprising the nutraceutical formulation.

[0083] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder, wherein the nutraceutical formulation further includes a phytoesterogen, wherein the phytoestrogen chosen from black cohosh and soya isofavones, and wherein the menstrual cycle disorder is perimenopause or early menopause.

[0084] Disclosed teachings provide a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of comprising:Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg; extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg; extract of dried leaf of Gingko biloba ranging from about 50 mg to about 200 mg; Black cohosh ranging from about 50 mg to about 200 mg; and Soya Isoflavones (extracted from soya beans) ranging from about 10 mg to about 100 mg in 5 grams of a composition comprising the nutraceutical formulation.

[0085] Disclosure provides a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca); about 120 mg of extract of dried leaf of Gingko biloba; about 100 mg of Black cohosh; and about 50 mg of Soya Isoflavones in 5 grams of a composition comprising the nutraceutical formulation.

[0086] Disclosure provides a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of further comprising an antioxidant and an other ingredient.

[0087] Disclosure provides a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder, wherein the phytonutrient comprises Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of ashwagandha (Withania somnifera), and Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), and wherein the menstrual cycle disorder is selected from the group consisting of endometriosis, fibroid, adenomyosis, breast cancer, an estrogen related cancer, wherein the estrogen related cancer is selected from the group consisting of cervical cancer, uterine cancer, ovarian cancer and combinations thereof.

[0088] Disclosure provides a nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder comprising: Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg; extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg in 5 grams of a composition comprising the nutraceutical formulation.

[0089] Disclosure provides a nutraceutical formulation for treating a hormonal imbalance affecting the menstrual cycle disorder comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera);about 100 mg of extract of bark of Ashoka (Saraca asoca) in 5 grams of a composition comprising the nutraceutical formulation.

[0090] Disclosure provides nutraceutical formulations for treating a hormonal imbalance affecting the menstrual cycle disorder, wherein the antioxidant is selected from the group consisting of glutathione, N-Acetyl Cysteine, extract of vijaysar (Pterocarous marsupium), resveratrol, pterostilbene, and combinations thereof.

[0091] Disclosure provides nutraceutical formulation for treating a hormonal imbalance affecting the menstrual cycle disorder comprising: Glutathione ranging from about 50 mg to about 200 mg; N-acetyl cysteine ranging from about 50 mg to about 200 mg; and Extract of grape (Vitis) ranging from 40 mg to about 100 mg in 5 grams of a composition comprising the nutraceutical formulation, and wherein the extract of grape (Vitis) comprises about 1% to about 5% of reservatrol.

[0092] Disclosure provides nutraceutical formulations for treating a menstruation- related hormonal imbalance comprising: Glutathione ranging from about 50 mg to about 200 mg; N-acetyl cysteine ranging from about 50 mg to about 200 mg; and extract of vijaysar (Pterocarous marsupium) ranging from 40 mg to about 100 mg in 5 grams of a composition comprising the nutraceutical formulation, and wherein the extract of vijaysar (Pterocarous marsupium) comprises about 1 % to about 5% of pterostilbene.

[0093] Disclosure provides nutraceutical formulations for treating a hormonal imbalance affecting the menstrual cycle disorder, wherein the other ingredient is selected from the group consisting of a Cruciferous vegetable ingredient, a probiotic and a calcium salt, wherein the cruciferous vegetable ingredient is selected from the group consisting of a cruciferous vegetable fibre, an active ingredient of a cruciferous vegetable, a derivative of an active ingredient of a cruciferous vegetable, Diindolylmethane (DIM), Indole-3-Carbinol (I3C), the probiotic is selected from the group consisting of Lactobacillus and Bifido bacterium, and the Calcium salt is selected from the group consisting of Calcium Di-Glucarate, Calcium Gluconate, Calcium Di- Saccharate or combinations thereof.

[0094] Some embodiments provide nutraceutical formulations for treating a hormonal imbalance affecting the menstrual cycle disorder comprising: the cruciferous vegetable ingredient ranging from about 100 mg to about 500 mg; the probiotic ranging from about 5 million to about 20 million; and, the calcium salt ranging from about 100 mg to about 500 mg in 5 grams of a composition.

[0095] Some embodiments provide nutraceutical formulations for treating a hormonal imbalance affecting the menstrual cycle disorder, wherein the micronutrient is selected from the group consisting of Vitamin C, Calcium carbonate, magnesium sulphate, Zinc Sulphate, Vitamin B5 sodium chloride, potassium chloride, Vitamin B3, vitamin B1, vitamin B2, vitamin B6, ferrous Fumerate, manganese sulphate, Folic acid, Folate, Vit A (acetate), sodium Selenite, Biotin, chromium picolinate, potassium iodide, vitamin B12, L-glutamine, L-Taurine, L-lysine, Vitamin D and combinations thereof.

[0096] A dosage of the disclosed nutraceutical formulations for treating the hormonal imbalance affecting the menstrual cycle disorder is about 5 gm of the nutraceutical formulation per day.

[0097] A dosage form of the nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder is chosen from tablet, capsule, powder and decoction.

[0098] Disclosure provides methods for treating a hormonal imbalance affecting a menstrual cycle disorder. The method comprises administering the nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder to a subject in need thereof, wherein the menstrual cycle disorder is chosen from premenstrual syndrome, hypomenorrhea, dysmenorrhea, amenhorrhea, oligomenorrhea, menorraghia, perimeopause, early menopause, endometriosis, fibroid, adenomyosis, breast cancer, an estrogen related cancer, and wherein the estrogen related cancer is chosen from cervical cancer, uterine cancer, ovarian cancer or combinations thereof.

[0099] Disclosure provides a method for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein an improvement in pain is observed after 3 months of treatment.

[0100] Disclosure provides a method for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein an improvement in bleeding is observed after 3 months of treatment.

[0101] Disclosure provides methods for regularizing menstrual cycle in terms of intermittent or irregular frequency of periods, duration of period, and / or flow of blood in terms of quantity and clots.

[0102] In some embodiments, a nutraceutical formulation comprises PhytoNutrients, Antioxidants, Micronutrients and Other ingredients which promotes healthy estrogen metabolism, detoxification and chelating agents and the said formulation balances hormones naturally by working on glands like Hypothalamus, Pituitary, Adrenal.

[0103] Phytonutrient is selected from the natural herbs such as Shatavari, Ashwagandha or its extract, Ashoka or its extract, Gingo Biloba, Black Cohosh, Isoflavone or mixture thereof.

[0104] Antioxidant can be Glutathione, N-Acetyl Cysteine, Resveratrol, Pterostilbene or mixture thereof.

[0105] “Other ingredient” can be Cruciferous vegetable Fibres or its active ingredients / derivatives like Diindolylmethane (DIM), Indole-3-Carbinol(I3C), Probiotics like Lactobacillus, Bifido bacterium, Calcium salts like Calcium Di- Glucarate, Calcium Gluconate, Calcium Di-Saccharate or mixture thereof.

[0106] Micronutrients can include Vitanin C, Calcium carbonate, magnesium sulphate, Zinc Sulphate, Vitamin B5 sodium chloride, potassium chloride, Vitamin B3,B1,B2,B6, ferroum Fummerate, manganese sulphate, Folic acid / Foliate, Vit.A (acetate), Sodium Selenite, Biotin, Chromium Picolinate, Potasium Iodide, Vitamin B12, L-Glutamine, L-Taurine,L-Lysine, Vitamin D or mixture thereof.

[0107] Phytonutrients in some embodiments of the nutraceutical formulations and their pharmaceutical activity and dosage quantity is summarized as below: Phytonutrient Dosage limit Pharmaceutical activity antioxidant, strengthens uterus, Shatavari 500-2000mg balances hormones byHypothalamus-pituitary-Ovary (HPO) axis. antioxidant, balances hormones by hypothalamus-pituitary- Ashwagandha extract 50-200mg adrenal (HPA) axis. Ashoka extract 50-200mg anti-inflammatory increases blood flow by dilating Gingo Biloba 50-200mg vessels improves estrogen levels in Black Cohosh 50-200mg menopause improves estrogen levels in Isoflavone 10-100mg menopause

[0108] Similarly antioxidants and dosage limit of each used in the present nutraceutical formulation of present invention is summarised as below: Antioxidants Glutathione 50-200 mg N-Acetyl Cysteine 50-200mg Resveratrol or Pterostilbene 40-100mg

[0109] A list of other ingredients, activity of each and dosage limit of each used in the nutraceutical formulation of present invention is given herein below: Other ingredientsCruciferous vegetable Fibres or its active ingredients / derivatives like Diindolylmethane (DIM), promotes healthy estrogen Indole-3-Carbinol(I3C) 100-5000mg metabolism Probiotics like Lactobacillus, Bifido bacterium etc 5million / 10-20mg detoxification Calcium salts like Calcium Di-Glucarate, Calcium Gluconate, Calcium Di- Saccharate etc 100-500mg Chelating agents

[0110] A list of micronutrients, pharmaceutical activity and dosage of each in the nutraceutical formulation of present invention is given herein below: act as catalyst in various pathways for hormone synthesis & Micronutrients metabolism Vit. C 10-100 mg Calcium Carbonate 10-100 mg Magnesium Sulfate 10-100 mg Zinc Sulfate 10-100 mg Vit B515 mg Sod. Chloride 10-100 mg Potassium Chloride 10-100 mg Vit.B31-10mg Ferrous Fumerate 1-10mg Vit. B61-10mgVit B2 1-10mg Vit.B1 1-10mg Manganese Sulfate 1-10mg Folic Acid / Folate 0.1-1mg Vit.A (acetate) 0.01-0.05mg Sod. Selenite 10-100 mcg Biotin 10-100 mcg Chromium Picolinate 1-10mcg Potassium Iodie 1-10mcg Vit. B12 1-10mcg L-Glutamine 0.1-1 mcg L-Taurine 0.1-1 mcg L-Lysine 0.56 mcg Vit.D 400 I.U.

[0111] The said formulation disclosed herein in this embodiment is used for the treatment of regularisation of menstrual cycle, Menopause, Endometriosis, fibroids, adenomyosis, breast cancer and other estrogen related cancers like cervical, uterine & ovarian cancers.

[0112] In some embodiments provide nutraceutical formulations for the treatment of Endometriosis, fibroids, adenomyosis, breast cancer and other estrogen related cancers like cervical, uterine & ovarian cancers and the said formulation comprises mixture of phytonutrient selected from Shatavari, Ashwagandha, Ashoka; Glutathione as an oxidant, other ingredients selected from the group comprising Cruciferous vegetable Fibres or its active ingredients / derivatives like Diindolylmethane (DIM), Indole-3- Carbinol(I3C), Probiotics like Lactobacillus, Bifido bacterium, Calcium salts like Calcium Di-Glucarate, Calcium Gluconate, Calcium Di-Saccharate or mixture thereofand Micronutrients is selected from the group comprising Vitanin C, Calcium carbonate, magnesium sulphate, Zinc Sulphate, Vitamin B5 sodium chloride, potassium chloride, Vitamin B3,B1,B2,B6, ferroum Fummerate, manganese sulphate, Folic acid / Foliate, Vit.A (acetate), Sod. Selenite, Biotin, Chromium Picolinate, Potasium Iodide, Vitamin B12, L-Glutamine, L-Taurine,L-Lysine, Vitamin D or mixture thereof.

[0113] The dosage quantity of each ingredient of this embodiment is disclosed herein above in the first embodiment.

[0114] Some embodiments provide nutraceutical formulations for treatment to regularise menstrual cycle having Phytonutrients comprising mixture of Shatavari, Ashwagandha, Ashoka & Gingko Biloba and mixture of all Micronutrients is selected from the group comprising Vitanin C, Calcium carbonate, magnesium sulphate, Zinc Sulphate, Vitamin B5 sodium chloride, potassium chloride, Vitamin B3, B1, B2, B6, ferroum Fummerate, manganese sulphate, Folic acid / Foliate, Vit. A (acetate), Sodium Selenite, Biotin, Chromium Picolinate, Potasium Iodide, Vitamin B12, L-Glutamine, L-Taurine, L-Lysine, Vitamin D. The dosage quantity of each ingredient of this embodiment is disclosed herein above.

[0115] Some embodiments provide nutraceutical formulations for the treatment of Menopause having Phytonutrients selected from Shatavari, Ashwagandha, Ashoka, Gingko Biloba, Black Cohosh, Soya Isoflavones and mixture thereof and mixture of all Micronutrients is chosen from Vitamin C, Calcium carbonate, magnesium sulphate, Zinc Sulphate, Vitamin B5 sodium chloride, potassium chloride, Vitamin B3,B1,B2,B6, ferroum Fummerate, manganese sulphate, Folic acid / Foliate, Vit.A (acetate), Sod. Selenite, Biotin, Chromium Picolinate, Potasium Iodidem Vitamin B12, L-Gkutamine, L-Taurine,L-Lysine, Vitamin D, and myo-Inositol.

[0116] The dosage quantity of each ingredient of this embodiment is disclosed above.

[0117] In some embodiments of the nutraceutical formulations, roots bark, saps, roots, extract, herb as whole or seeds from these plants as the source of phytonutrients may be used.

[0118] In some embodiments the nutraceutical formulation may be dried, converted into powder, and packaged for use directly, or processed into a pill or digestible capsule form.

[0119] In some embodiments the nutraceutical formulation may be used as decoction, brew, water extract, alcohol extract, or pulp mixture and the like.

[0120] In some embodiments the nutraceutical formulation is intended for ingestion by a women user, for their well-being.

[0121] A nutraceutical Formulation to regularize menstrual cycle.

[0122] A blend of Phytonutrients and micronutrients is prepared and details are given herein below in Table 1. Micronutrients act as catalyst in various pathways for hormone synthesis & metabolism. When there is heavy bleeding Gingko biloba is not administered because it increases blood flow, for example, when menstrual pad or tampon gets about 50% soaked in less than 4 hours.

[0123] Table-1 Phytonutrients antioxidant, strengthens uterus, balances hormones by Shatavari 500-2000mg HPO axis.antioxidant, balnces hormones Ashwagandha extract 50-200mg by HPA axis. Ashoka extract 50-200mg anti-inflamatory increases blood flow by Gingo Biloba 50-200mg dilating vessels Micronutrients: Act as catalyst in various pathways for hormone synthesis & metabolism Micronutrients Vit. C 10-100 mg Calcium Carbonate 10-100 mg Magnesium Sulfate 10-100 mg Zinc Sulfate 10-100 mg Vit B5 15 mg Sod. Chloride 10-100 mg Potassium Chloride 10-100 mg Vit.B31-10mg Ferrous Fumerate 1-10mg Vit. B61-10mg Vit B2 1-10mg Vit.B11-10mg Manganese Sulfate 1-10mg Folic Acid / Folate 0.1-1mg Vit.A (acetate) 0.01-0.05mg Sod. Selenite 10-100 mcg Biotin 10-100 mcg Chromium Picolinate 1-10mcgPotassium Iodie 1-10mcg Vit. B12 1-10mcg L-Glutamine 0.1-1 mcg L-Taurine 0.1-1 mcg L-Lysine 0.56 mcg Vit.D 400 I.U.

[0124] Formulation for Menopause: A blend of Phytonutrients and micronutrients is prepared and details are given herein below in Table-2. Micronutrients act as act as catalyst in various pathways for hormone synthesis & metabolism. Menopause formulation (Table-2) includes black cohosh and isoflavones because they are phytoestrogens in addition to the ingredients listed in Table-1 above for regularizing menstrual cycle.

[0125] Table-2 Phytonutrients: antioxidant, strengthens uterus, balances hormones by HPO Shatavari 500-2000mg axis. antioxidant, balances hormones Ashwagandha extract 50-200mg by HPA axis. Ashoka extract 50-200mg anti-inflamatory increases blood flow by dilating Gingko Biloba 50-200mg vessels improves estrogen levels in Black Cohosh 50-200mg menopauseimproves estrogen levels in Isoflavone 10-100mg menopause Micronutrients: Act as catalyst in various pathways for hormone synthesis and metabolism. Micronutrients Vit. C 10-100 mg Calcium Carbonate 10-100 mg Magnesium Sulfate 10-100 mg Zinc Sulfate 10-100 mg Vit B515 mg Sod. Chloride 10-100 mg Potassium Chloride 10-100 mg Vit.B3 1-10mg Ferrous Fumerate 1-10mg Vit. B6 1-10mg Vit B21-10mg Vit.B1 1-10mg Manganese Sulfate 1-10mg Folic Acid / Folate 0.1-1mg Vit.A (acetate) 0.01-0.05mg Sod. Selenite 10-100 mcg Biotin 10-100 mcg Chromium Picolinate 1-10mcg Potassium Iodide 1-10mcg Vit. B12 1-10mcg L-Glutamine 0.1-1 mcgL-Taurine 0.1-1 mcg L-Lysine 0.56 mcg Vit.D 400 I.U.

[0126] Nutraceutical Formulation for Endometriosis, fibroids, adenomyosis, breast cancer and other hormone related cancers like cervical, uterine & ovarian cancers can be a blend of phytonutrients, antioxidant, micronutrients and other ingredients as described in Table-3. A blend of phytonutrients (shatavari, ashwagandha and Ashoka), antioxidants (glutathione, reservaterol, pterostilbene and NAC), micronutrients and other ingredients as described in Table-3.

[0127] Table-3 Phytonutrients: antioxidant, strengthens uterus, Shatavari 500-2000mg balnces hormones by HPO axis. antioxidant, balnces hormones Ashwagandha extract 50-200mg by HPA axis. Ashoka extract 50-200mg anti-inflamatory Antioxidants Glutathione 50-200 mg Other ingredients Cruciferous vegetable Fibres or its active ingredients / derivatives like Diindolylmethane (DIM), promotes healthy estrogen Indole-3-Carbinol(I3C) 100-5000mg metabolismProbiotics like Lactobacillus, Bifido bacterium etc 5million / 10-20mg detoxification Calcium salts like Calcium Di- Glucarate, Calcium Gluconate, Calcium Di-Saccharate etc 100-500mg Chelating agentsact as catalyst in various pathways for hormone Micronutrients synthesis & metabolism Vit. C 10-100 mg Calcium Carbonate 10-100 mg Magnesium Sulfate 10-100 mg Zinc Sulfate 10-100 mg Vit B515 mg Sod. Chloride 10-100 mg Potassium Chloride 10-100 mg Vit.B31-10mg Ferrous Fumerate 1-10mg Vit. B6 1-10mg Vit B2 1-10mg Vit.B11-10mg Manganese Sulfate 1-10mg Folic Acid / Folate 0.1-1mg Vit.A (acetate) 0.01-0.05mg Sod. Selenite 10-100 mcg Biotin 10-100 mcg Chromium Picolinate 1-10mcg Potassium Iodie 1-10mcg Vit. B121-10mcg L-Gkutamine 0.1-1 mcg L-Taurine 0.1-1 mcg L-Lysine 0.56 mcg Vit.D 400 I.U.

[0128] It will be readily understood by the skilled artisan that numerous alterations may be made to the examples and instructions given herein. These and other objects and features of present invention will be made apparent from the following examples. The following examples as described are not intended to be construed as limiting the scope of the present invention. EXAMPLES Example 1

[0129] Results of a clinical study carried out at 3 reputed hospitals for menstrual abnormalities in 131 patients using formulations as described in Table 4 which corresponds to ranges provided in Table 1 is given below.

[0130] One scoop (5 grams) of nutritional formulation of Table 4 was administered in 100 ml water to each patient for 3 menstrual cycles. For heavy menstrual bleeding the formulation was given without gingko biloba. Results are provided in Table 5 below.

[0131] Table 4 Formulation tested for infrequent cycles, heavy menstrual bleeding and dysmenorrhea Ingredients Information (Approximate Values) Ingredients Per serving Per 100 g %* RDA 5 g Per Serving Ashwagandha Root Ext. 100 mg 2000 mg ** Ashoka Bark Ext. 100 mg 2000 mg ** Vitamin C (L-Ascorbic Acid) 40 mg 800 mg 61.5% Calcium Carbonate 40 mg 800 mg 1.6% Magnesium Sulphate 40 mg 800 mg 2.18% Zinc Sulphate 30 mg 600 mg 92.03%Sodium Chloride 10 mg 200 mg 0.19% Potassium Chloride 10 mg 200 mg 0.11% Vitamin B5 (Calcium D- 5 mg 100 mg 100% Pantothenate) Vitamin B3 (Nicotinamide) 2.2 mg 44 mg 20% Ferrous Fumarate 2 mg 40 mg 2.27% Vitamin B6 (Pyridoxine HCl) 1.9 mg 38 mg 100% Vitamin B2 (Riboflavin) 1.6 mg 32 mg 84.21% Vitamin B1 (Thiamine 1.4 mg 28 mg 100% Mononitrate) Manganese Sulphate 0.6 mg 12 mg 5.45% Vitamin B9 (Folic Acid) 129.45 mcg 2589 mcg 100% Sodium Selenite 40 mcg 800 mcg 45.65% Vitamin B7 (D-Biotin) 30 mcg 600 mcg 75% Vitamin A (Retinyl Acetate) 20 mcg 400 mcg 2.38% Vitamin D2 (Ergocalciferol) 400 i.u. 8000 i.u. 66.67% Chromium Picolinate 2 mcg 40 mcg ** Potassium Iodide 2 mcg 40 mcg 1.09% Vitamin B12 (Cyanocobalamin) 1 mcg 20 mcg 45.45% L-Glutamine 0.85 mcg 17 mcg ** L-Taurine 0.71 mcg 14.2 mcg ** L-Lysine^ Excipients 0.56 mcg q.s. 11.2 mcg 0% q.s. Excipients q.s. q.s. # Dietary fiber produce 2 Kcal per gram.

[0132] Table 5 Improvement of Menstrual Cycle Pattern after 3 cyclesStudy Parameter At recruitment End of third cycle Result Infrequent Cycles 56% 11% Normal Frequency restoration in 88% Heavy Menstrual 67% 17% Reduction in Bleeding (gingko biloba blood flow in was not included in the 77% formulation) Dysmenorrhoea 21% 11.3% Improvement in pain score in 58%

[0133] Predicted results of the combination of individual groups (Phytonutrients and Antioxidants and Micronutrients) as given in the formulation in Table 4 above, was expected to improve above parameters by maximum of 20%in 3 months / cycles, however the observed results (in Table 5) of administering the combination of individual groups (namely Phytonutrients and Antioxidants and Micronutrients) showed normal frequency restoration of infrequent cycles in 88% of patients, reduction in blood flow in heavy menstrual bleeding in 77% of patients, improvement in pain score in 58% of patients having dysmenorrhea, which shows unexpected results from administering the combination of phytonutrient, micronutrient and antioxidants and shows the synergistic effects of the combination treatment.

[0134] The following formulation Table 6 was tested for infrequent cycles.

[0135] Results with 2g Shatavari alone after 3 cycles of treatment.Study Parameter Results Infrequent Cycles Normal Frequency restoration in 30%? Heavy Menstrual Bleeding Reduction in blood flow in 10% Dysmenorrhoea Improvement in pain score in 10%

[0136] Results with 100 mg extract of root of Ashwagandha after 3 cycles Study Parameter Results Infrequent Cycles Normal Frequency restoration in 0% Heavy Menstrual Bleeding Reduction in blood flow in 0% Dysmenorrhoea Improvement in pain score in 0%

[0137] Results with 100 mg extract of bark of Ashoka after 3 cycles. Study Parameter Results Infrequent Cycles Normal Frequency restoration in 0% Heavy Menstrual Bleeding Reduction in blood flow in 0% Dysmenorrhoea Improvement in pain score in 0%

[0138] Results of with Phytonutrient combination of Shatavari / Ashwagandha / Ashoka after 3 cycles.

[0139] Results with micronutrient combination as in Table 4? after 3 cycles. Study Parameter Results Infrequent Cycles Normal Frequency restoration in 0% Heavy Menstrual Bleeding Reduction in blood flow in 0% Dysmenorrhoea Improvement in pain score in 0%

[0140] Results with micronutrient combination and extract of dried leaf of Gingko Biloba after 3 cycles. Study Parameter Results Infrequent Cycles Normal Frequency restoration in 0% Dysmenorrhoea Improvement in pain score in 10%

[0141] Summarizing the results of treatment with phytonutrient alone or micronutrient alone or combination of phytonutrient and micronutrient. Improvement in abnormal uterine bleeding (AUB) pattern with administration of individual ingredients, such as phytonutrients alone, or micronutrients (multivitamins) alone and with a combination of phytonutrients and micronutrients is provided below showing synergistic effect of the combination of phytonutrient and micronutrient. Administering Shatavari alone improved infrequent cycles by about 30%, ashwagandha extract alone improved infrequent cycles by 0%; Ashoka extract alone improved infrequent cycles by 0%, Gingko Biloba alone improved infrequent cycles by 0%, combination of multivitamins improved infrequent cycles by 0%, therefore predicted improvement in infrequentcycles by administering a combination of shatavari, ashwagandha extract, Ashoka extract, gingko biloba extract and combination of multivitamins is about 30%, whereas the observed effect of the combination of shatavari, ashwagandha extract, Ashoka extract, gingko biloba extract and combination of multivitamins on improvement in infrequent cycles was about 88%, which shows the unexpected results from administering the combination of phytonutrients and micronutrients and that the combination of phytonutrients and micronutrients exhibited synergistic effects.

[0142] Administering Shatavari alone improved heavy bleeding by about 20%, ashwagandha extract alone improved heavy bleeding by 0%; Ashoka extract alone improved heavy bleeding by 0%, Gingko Biloba alone administration on heavy bleeding is not applicable (NA), combination of multivitamins improved heavy bleeding by 0%, therefore predicted improvement in administering a combination of shatavari, ashwagandha extract, Ashoka extract, gingko biloba extract and combination of multivitamins is about 20%, whereas the observed effect of the combination of shatavari, ashwagandha extract, Ashoka extract, gingko biloba extract and combination of multivitamins on heavy bleeding was unexpectedly about 77%, which shows that the combination of phytonutrients and micronutrients exhibited synergistic effects.

[0143] Administering Shatavari alone improved pain by about 20%, ashwagandha extract alone improved pain by 0%; Ashoka extract alone improved pain by 0%, Gingko Biloba alone improved pain by 10%, combination of multivitamins improved pain by 0%, therefore predicted improvement in pain by administering a combination of shatavari, ashwagandha extract, Ashoka extract, gingko biloba extract and combination of multivitamins is about 30%, whereas the observed effect of the combination of shatavari, ashwagandha extract, Ashoka extract, gingko biloba extract and combination of multivitamins on improvement in pain was about 56%, which shows the unexpected results from administering the combination of phytonutrients and micronutrients and that the combination of phytonutrients and micronutrientsexhibited synergistic effects. when administered for months for 3 cycles i.e around 3 months) to a group of patients (10 each), age group (15-35), dosage as mentioned in the table) is provided below. Infrequent Heavy Cycles Bleeding Pain Shatavari 2gm 30% 20% 20% Ashwagandha extract of root 100mg 0% 0% 0% Ashoka extract of bark 100mg 0% 0% 0% Gingko Biloba extract of leaf 200 mg 0% NA 10% Combination of Micronutrients (multivitamins) mg 0% 0% 0% All of above (Shatavari 2gm and Ashwagandha ext 100mg and Ashoka ext 100mg and Gingko Biloba and Combination of Micronutrients (multivitamins) 88% 77% 56% Example 2

[0144] The following formulation was tested for perimenopause and early menopause. Nutritional information (Approximate Values) Per serving Per 100 g %* RDA 5 g Per Serving Energy 8.4 Kcal 168 Kcal 0.42% Total Fat 0 g 0 g ** Total Protein (on dry basis) 0 g 0 g ** Total Carbohydrate 2 g 40 g ** Added Sugar 0 g 0 g ** Dietary Fiber # (Wheat Dextrin) 0.2 g 4 g 0.5%Ingredients Information (Approximate Values) Ingredients Per serving Per 100 g %* RDA 5 g Per Serving Shatavari Powder 2 g 40 g ** Ginkgo Biloba Dried Leaf Ext 120 mg 2400 mg ** Black Cohosh Ext 100 mg 2000 mg ** Ashwagandha Root Ext. 100 mg 2000 mg ** Ashoka Bark Ext. 100 mg 2000 mg ** Soya Isoflavones 50 mg 1000 mg ** Vitamin C (L-Ascorbic Acid) 40 mg 800 mg 61.5% Calcium Carbonate 40 mg 800 mg 1.6% Magnesium Sulphate 40 mg 800 mg 2.18% Zinc Sulphate 30 mg 600 mg 92.03% Sodium Chloride 10 mg 200 mg 0.19% Potassium Chloride 10 mg 200 mg 0.11% Vitamin B5 (Calcium D- 5 mg 100 mg 100% Pantothenate) Vitamin B3 (Nicotinamide) 2.2 mg 44 mg 20% Ferrous Fumarate 2 mg 40 mg 2.27% Vitamin B6 (Pyridoxine HCl) 1.9 mg 38 mg 100% Vitamin B2 (Riboflavin) 1.6 mg 32 mg 84.21% Vitamin B1 (Thiamine 1.4 mg 28 mg 100% Mononitrate) Manganese Sulphate 0.6 mg 12 mg 5.45% Vitamin B9 (Folic Acid) 129.45 mcg 2589 mcg 100% Sodium Selenite 40 mcg 800 mcg 45.65% Vitamin B7 (D-Biotin) 30 mcg 600 mcg 75% Vitamin A (Retinyl Acetate) 20 mcg 400 mcg 2.38%Vitamin D2 (Ergocalciferol) 400 i.u. 8000 i.u. 66.67% Chromium Picolinate 2 mcg 40 mcg ** Potassium Iodide 2 mcg 40 mcg 1.09% Vitamin B12 (Cyanocobalamin) 1 mcg 20 mcg 45.45% L-Glutamine 0.85 mcg 17 mcg ** L-Taurine 0.71 mcg 14.2 mcg ** L-Lysine^ Excipients 0.56 mcg q.s. 11.2 mcg q.s. 0% Excipients q.s. q.s. # Dietary fiber produce 2 Kcal per gram.

[0145] There was a marked improvement in hot flashes, insomnia, mood swings, in menopausal symptoms. Example 3

[0146] The following formulation in Table below was tested for Endometrosis and fibroids. Total no of patients – 100. Predicted Results with individual ingredients individually or combination of individual groups (Phytonutrients only or Antioxidants only or Micronutrients only) as given in the Table below could improve above parameters by max 18% in 3 months.

[0147] Table 6 (This has Shatavari – so used for Table 4 does not have Shatavari) NUTRACEUTICAL (13.6) / Supplement FactsNutritional information (Approximate Values) Per serving Per 100 g %* RDA 5 g Per Serving Energy 7.16 Kcal 143.2 Kcal 0.35% Total Fat 0 g 0 g ** Total Protein (on dry basis) 0 g 0 g ** Total Carbohydrate 1.89 g 37.8 g ** Net Carbohydrate 1.69 g 33.8 g ** Added Sugar 0 g 0 g ** Dietary Fiber # (Wheat Dextrin) 0.2 g 4 g 0.8% Ingredients Information (Approximate Values) Ingredients Per serving Per 100 g %* RDA 5 g Per Serving Shatavari Powder 2 g 40 g ** Ashwagandha Root Ext. 100 mg 2000 mg ** Ashoka Bark Ext. 100 mg 2000 mg ** Vitamin C (L-Ascorbic Acid) 40 mg 800 mg 61.5% Calcium Carbonate 40 mg 800 mg 1.6% Magnesium Sulphate 40 mg 800 mg 2.18% Zinc Sulphate 30 mg 600 mg 92.03% Sodium Chloride 10 mg 200 mg 0.19% Potassium Chloride 10 mg 200 mg 0.11% Vitamin B5 (Calcium D- 5 mg 100 mg 100% Pantothenate) Vitamin B3 (Nicotinamide) 2.2 mg 44 mg 20% Ferrous Fumarate 2 mg 40 mg 2.27% Vitamin B6 (Pyridoxine HCl) 1.9 mg 38 mg 100% Vitamin B2 (Riboflavin) 1.6 mg 32 mg 84.21%Vitamin B1 (Thiamine 1.4 mg 28 mg 100% Mononitrate) Manganese Sulphate 0.6 mg 12 mg 5.75% Vitamin B9 (Folic Acid) 129.45 mcg 2589 mcg 100% Sodium Selenite 40 mcg 800 mcg 45.65% Vitamin B7 (D-Biotin) 30 mcg 600 mcg 75% Vitamin A (Retinyl Acetate) 20 mcg 400 mcg 2.38% Vitamin D2 (Ergocalciferol) 400 i.u. 8000 i.u. 66.67% Chromium Picolinate 2 mcg 40 mcg ** Potassium Iodide 2 mcg 40 mcg 1.09% Vitamin B12 (Cyanocobalamin) 1 mcg 20 mcg 45.45% L-Glutamine 0.85 mcg 17 mcg ** L-Taurine 0.71 mcg 14.2 mcg ** L-Lysine^ Excipients 0.56 mcg q.s. 11.2 mcg 0% q.s. Excipients q.s. q.s. # Dietary fiber produce 2 Kcal per gram. Ingredients Information (Approximate Values) Ingredients Per serving Per 100 g %* RDA 5 g Per Serving Lactic Acid Bacillus (.5 billion) 16.67 mg 333.40 mg ** L-Glutathione reduced 100 mg 2000 mg ** Calcium gluconate 100 mg 2000 mg ** Vitamin C (Ascorbic acid) 80 mg 1.60 g 100% Vitamin B1 (Thiamine mono nitrate) 1.40 mg 28 mg 100% Vitamin B2 (Riboflavin sodium phosphate 2 mg 40 mg 100% Vitamin B3 (Niacinamide) 14 mg 280 mg 100%Vitamin B5 (Calcium Pantothenate) 5.45 mg 109 mg 100% Vitamin B6 (Pyridoxine HCI) 1.90 mg 38 mg 100% Vitamin B9 (Folic acid) 300 mcg 6 mg 100% Vitamin B12 (Cynocobalamin) 1 mcg 20 mcg 50% Vitamin D2 (Ergocalciferol) 600 i.u. 12000 i.u. 100% Zinc (Zinc citrate) 6.60 mg 132 mg 50% Selenium (L-Selenomethionine) 40 mcg 800 mcg 100% Manganese (Manganese chloride) 4 mg 80 mg 100% Magnesium (Magnesium citrate) 32 mg 640 mg 10% Chromium (Chromium chloride) 50 mg 1 mg 100% Iron (Ferrous fumarate) 7.25 mg 145 mg 25% lodine (Potassium iodide) 75 mg 1.50 mg 50% Vegetable Fiber 500 mg 10 gm 2% *Indian Council of Medical Research Recommended Daily Allowance RDA Values are calculated based on RDA 2020 for Women - Sedentary Life

[0148] Improvement in Endometriosis & Fibroids after 3 months Study Parameter At recruitment End of third cycle Result Pain 100% 5% Improvement in pain in 95% Heavy Menstrual 62% 4% Reduction in Bleeding blood flow in 93.5%

[0149] Other modifications and variations to the invention will be apparent to those skilled in the art from the foregoing disclosure and teachings. Thus, while only certain embodiments of the invention have been specifically described herein, it will beapparent that numerous modifications may be made thereto without departing from the spirit and scope of the invention.

Claims

I Claim:

1. A nutraceutical formulation for treating a hormonal imbalance affecting a menstrual cycle disorder, wherein the nutraceutical formulation comprises a phytonutrient and a micronutrient.

2. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 1, wherein the phytonutrient is chosen from Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), gingko biloba or extract of dried leaf of Gingko Biloba, and combinations thereof, wherein the menstrual cycle disorder is chosen from premenstrual syndrome, hypomenorrhea, dysmenorrhea, amenhorrhea, oligomenorrhea, and menorraghia.

3. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 1, wherein the phytonutrient is selected from the group consisting of Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), gingko biloba or extract of dried leaf of Gingko Biloba, and combinations thereof, wherein the menstrual cycle disorder is chosen from premenstrual syndrome, hypomenorrhea, dysmenorrhea, amenohorrhea, and oligomenorrhea.

4. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 3 comprising: Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg:extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg; and, extract of dried leaf of Gingko biloba ranging from about 50 mg to about 200 mg in 5 grams of a composition comprising the nutraceutical formulation.

5. The nutraceutical formulation for the menstruation-related hormonal imbalance of claim 4 comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca); and, about 200 mg of extract of dried leaf of Gingko biloba in 5 grams of a composition comprising the nutraceutical formulation.

6. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 2, wherein the phytonutrient comprises Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of Ashwagandha (Withania somnifera), Ashoka (Saraca asoca) or extract of Ashoka (Saraca asoca), and wherein the menstrual cycle disorder is menorraghia.

7. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 6 comprising: Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg: extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg; in 5 grams of a composition comprising the nutraceutical formulation.

8. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 6 comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca); and, in 5 grams of a composition comprising the nutraceutical formulation.

9. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 1 further comprising a phytoesterogen, wherein the phytoestrogen chosen from black cohosh and soya isofavones, and wherein the menstrual cycle disorder is perimenopause or early menopause.

10. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 9 comprising: Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg; extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg; extract of dried leaf of Gingko biloba ranging from about 50 mg to about 200 mg; Black cohosh ranging from about 50 mg to about 200 mg; and Soya Isoflavones (extracted from soya beans) ranging from about 10 mg to about 100 mg in 5 grams of a composition comprising the nutraceutical formulation.

11. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 10 comprising: about 2 grams of Shatavari (Asparagus racemosus);about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca); about 120 mg of extract of dried leaf of Gingko biloba; about 100 mg of Black cohosh; and about 50 mg of Soya Isoflavones in 5 grams of a composition comprising the nutraceutical formulation.

12. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 1 further comprising an antioxidant and another ingredient.

13. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 12, wherein the phytonutrient comprises Shatavari (Asparagus racemosus), ashwagandha (Withania somnifera) or extract of root of ashwagandha (Withania somnifera), and Ashoka (Saraca asoca) or extract of bark of Ashoka (Saraca asoca), and wherein the menstrual cycle disorder is selected from the group consisting of endometriosis, fibroid, adenomyosis, breast cancer, an estrogen related cancer, wherein the estrogen related cancer is selected from the group consisting of cervical cancer, uterine cancer, ovarian cancer and combinations thereof.

14. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 13 comprising: Shatavari (Asparagus racemosus) (Asparagus racemosus)(Asparagus racemosus)ranging from about 500 mg to about 2000 mg; extract of root of Ashwagandha (Withania somnifera) ranging from about 50 mg to about 200 mg; extract of bark of Ashoka (Saraca asoca) ranging from about 50 mg to about 200 mg in 5 grams of a composition comprising the nutraceutical formulation.

15. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 13 comprising: about 2 grams of Shatavari (Asparagus racemosus); about 100 mg of extract of root of Ashwagandha (Withania somnifera); about 100 mg of extract of bark of Ashoka (Saraca asoca) in 5 grams of a composition comprising the nutraceutical formulation.

16. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 12, wherein the antioxidant is selected from the group consisting of glutathione, N-Acetyl Cysteine, extract of vijaysar (Pterocarous marsupium), resveratrol, pterostilbene, and combinations thereof.

17. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 16 comprising: Glutathione ranging from about 50 mg to about 200 mg; N-acetyl cysteine ranging from about 50 mg to about 200 mg; and Extract of grape (Vitis) ranging from 40 mg to about 100 mg in 5 grams of a composition comprising the nutraceutical formulation, and wherein the extract of grape (Vitis) comprises about 1% to about 5% of reservatrol.

18. The nutraceutical formulation for treating the menstruation-related hormonal imbalance of claim 16 comprising: Glutathione ranging from about 50 mg to about 200 mg; N-acetyl cysteine ranging from about 50 mg to about 200 mg; and extract of vijaysar (Pterocarous marsupium) ranging from 40 mg to about 100 mg in 5 grams of a composition comprising the nutraceutical formulation, and wherein the extract of vijaysar (Pterocarous marsupium) comprises about 1 % to about 5% of pterostilbene.

19. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 12, wherein the other ingredient is selected from the group consisting of a Cruciferous vegetable ingredient, a probiotic and a calcium salt, wherein the cruciferous vegetable ingredient is selected from the group consisting of a cruciferous vegetable fibre, an active ingredient of a cruciferous vegetable, a derivative of an active ingredient of a cruciferous vegetable, Diindolylmethane (DIM), Indole-3- Carbinol (I3C), the probiotic is selected from the group consisting of Lactobacillus and Bifido bacterium, and the Calcium salt is selected from the group consisting of Calcium Di-Glucarate, Calcium Gluconate, Calcium Di-Saccharate and combinations thereof.

20. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 19 comprising: the cruciferous vegetable ingredient ranging from about 100 mg to about 500 mg; the probiotic ranging from about 5 million to about 20 million; and, the calcium salt ranging from about 100 mg to about 500 mg in 5 grams of a composition.

21. The nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 1, wherein the micronutrient is selected from the group consisting of Vitamin C, Calcium carbonate, magnesium sulphate, Zinc Sulphate, Vitamin B5 sodium chloride, potassium chloride, Vitamin B3, vitamin B1, vitamin B2, vitamin B6, ferrous Fumerate, manganese sulphate, Folic acid, Folate, Vit A (acetate), sodium Selenite, Biotin, chromium picolinate, potassium iodide, vitamin B12, L-glutamine, L-Taurine, L-lysine, Vitamin D and combinations thereof.

22. A dosage of the nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 1, wherein the dosage is about 5 gm of the nutraceutical formulation per day.

23. A dosage form of the nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 1, wherein the dosage form is chosen from tablet, capsule, powder and decoction.

24. A method for treating a hormonal imbalance affecting a menstrual cycle disorder, the method comprising administering the nutraceutical formulation for treating the hormonal imbalance affecting the menstrual cycle disorder of claim 1 to a subject in need thereof, wherein the menstrual cycle disorder is chosen from premenstrual syndrome, hypomenorrhea, dysmenorrhea, amenorrhea, oligomenorrhea, menorrhagia, perimenopause, early menopause, endometriosis, fibroid, adenomyosis, breast cancer, an estrogen related cancer, and wherein the estrogen related cancer is chosen from cervical cancer, uterine cancer, ovarian cancer and combinations thereof.

25. The method for treating a hormonal imbalance affecting a menstrual cycle disorder of claim 24, wherein an improvement in pain is observed after 3 months of treatment.

26. The method for treating a hormonal imbalance affecting a menstrual cycle disorder of claim 24, wherein an improvement in bleeding is observed after 3 months of treatment.

27. The method for treating a hormonal imbalance affecting a menstrual cycle disorder of claim 24, wherein an improvement in infrequent cycles is observed after 3 months of treatment.

28. The method for treating a hormonal imbalance affecting a menstrual cycle disorder of claim 24, wherein an improvement in duration of menstrual cycle is observed after 3 months of treatment.

29. The method for treating a hormonal imbalance affecting a menstrual cycle disorder of claim 24, wherein an improvement in quantity of flow of blood is observed after 3 months of treatment.

30. The method for treating a hormonal imbalance affecting a menstrual cycle disorder of claim 24, wherein an improvement in clots in blood is observed after 3 months of treatment.

31. The method for treating a hormonal imbalance affecting a menstrual cycle disorder of claim 24, wherein regularizing menstrual cycle is observed after 3 months of treatment.