Compositions for modulating menstrual cycle

Abstract

Provided here are seed compositions, dosage forms, kits, and their uses in improving hormone balance during menstrual cycle, modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).

Description

COMPOSITIONS FOR MODULATING MENSTRUAL CYCLECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No.63 / 631,978 filed April 9, 2024, which is hereby incorporated by reference herein in its entirety.BACKGROUND

[0002] Managing premenstrual syndrome (PMS) and hormonal imbalances can be challenging, and PMS can be prevalent in up to 75% of women.

[0003] Mood changes and PMDD (Premenstrual Dysphoric Disorder) is a more severe form of PMS that affects a smaller percentage of women. Some research may suggest that approximately 3-8% of women of reproductive age meet the criteria for PMDD. PMDD symptoms are more severe than those of PMS and can include significant mood disturbances, such as severe depression, anxiety, irritability, and mood swings, which can significantly interfere with daily functioning. It is important to note that these estimates can van depending on the population studied and the criteria used to diagnose PMS and PMDD. Additionally, many women may not seek medical help for their symptoms or may not be formally diagnosed, so the true prevalence of these conditions may be higher than reported.

[0004] There is need for natural approaches like seed cycling to provide promising benefits for women seeking alternative solutions.SUMMARY

[0005] The present disclosure provides seed compositions that can be used to improve the hormone balance during menstrual cycle, modulate the irregular menstrual cycle, alleviate or treat PMS or PMDD.

[0006] In one aspect, a dosage form is provided. The dosage form comprises about 30% w / w to about 70% w / w of flaxseed, and about 30% w / w to about 70% w / w of pumpkin seed.

[0007] In certain embodiments, the dosage form further comprises one or more selected from the group consisting of: (a) about 1.0% w / w to about 5% w / w of vitex, (b) about 2% w / w to about 7% w / w of black cohosh, (c) about 0.5% w / w to about 2% w / w of passionflower, (d) about 0.5% w / w to about 2% w / w of a hops, (e) about 0.5% w / w to about 3.5% w / w of a ladymantle, and (f) about 10% w / w to about 40% w / w of an evening primrose. In certain embodiments, the dosage form comprises about 35% w / w to about 60% w / w of the flaxseed. In certain embodiments, the flaxseed is concentrated at least 2 times with one or more nutrients selected from tire group consisting of alpha-linolenic acid (ALA), lignans, dietary fiber, plant protein, vitamins and minerals, and phytochemicals. In certain embodiments, the dosage formcomprises about 32% w / w to about 55% w / w of the pumpkin seed. In certain embodiments, the pumpkin seed is concentrated with one or more nutrients selected from the group consisting of lignan, zinc, omega- 3 fatty acids, magnesium, phytoestrogens and tryptophan. In certain embodiments, the dosage form comprises about 1.2% w / w to about 3.5% w / w of the vitex. In certain embodiments, the dosage fonn is a capsule or a tablet. In certain embodiments, the dosage fonn comprises about 300 mg to about 500 mg of the flaxseed and about 250 mg to about 400 mg of the pumpkin seed. In certain embodiments, the dosage form comprises about 300 mg to about 400 mg of the flaxseed and about 250 mg to about 400 mg of the pumpkin seed. In certain embodiments, the dosage form comprises about 600 mg to about 1000 mg of the flaxseed and about 500 mg to about 800 mg of the pumpkin seed. In certain embodiments, the dosage fomr comprises about 600 mg to about 800 mg of the flaxseed and about 500 mg to about 800 mg of the pumpkin seed.

[0008] In one aspect, a dosage form is provided. The dosage form comprises about 30% w / w to about 70% w / w of sesame seed, and about 30% w / w to about 70% w / w of sunflower seed.

[0009] In certain embodiments, the dosage form further comprises one or more selected from the group consisting of: (a) about 4% w / w-7% w / w psyllium, (b) about 1% w / w-5% w / w vitcx, (c) about 2% w / w- 7% w / w black cohosh, (d) about 0.5% w / w-2% w / w passionflower, (e) about 0.5% w / w-2% w / w hops, (I about 0.5% w / w-3.5% w / w ladymantle, and / or (g) about 10% w / w-25% w / w evening primrose. In certain embodiments, the dosage form comprises about 35% w / w to about 60% w / w of the sesame seed. In certain embodiments, the sesame seed is concentrated with one or more nutrients selected from the group consisting of fatty acids, vitamin B6, magnesium, calcium, lignans and phytoestrogen. In certain embodiments, the dosage form comprises about 32% w / w to about 55% w / w of the sunflower seed. In certain embodiments, the sunflower seed is concentrated one or more nutrients selected from the group consisting of lignans, vitamin E. selenium, essential fatty acids, and magnesium. In certain embodiments, the dosage form comprises about 1.2% w / w to about 3.5% w / w of the vitex. In certain embodiments, the dosage form is capsule or tablet. In certain embodiments, the dosage form comprises about 250 mg to about 500 mg of the sesame seed and about 250 mg to about 500 mg of the sesame seed. In certain embodiments, the dosage form comprises about 250 mg to about 400 mg of the sesame seed and about 250 mg to about 400 mg of the sunflower seed. In certain embodiments, the dosage form comprises about 500 mg to about 1000 mg of the sesame seed and about 500 mg to about 1000 mg of the sesame seed. In certain embodiments, the dosage form comprises about 500 mg to about 800 mg of the sesame seed and about 500 mg to about 800 mg of the sunflower seed.

[0010] In one aspect, a kit comprising the aforementioned dosage fonns are provided.

[0011] In one aspect, a kit comprising a first dosage form and a second dosage form is provided. Tire first dosage form comprises about 300 mg to about 500 mg of flaxseed, and about 250 mg to 400 mg of pumpkin seed. The second dosage form comprises about 250 mg to about 500 mg of sesame seed, and about 250 mg to about 500 mg of sunflower seed.

[0012] In certain embodiments, the first dosage fonn and the second dosage form are capsules or tablets. In certain embodiments, the first dosage form comprises about 300 mg to about 400 mg of tire flaxseed. In certain embodiments, the first dosage form comprises about 250 mg to about 350 mg of the pumpkin seed. In certain embodiments, the second dosage form comprises about 250 mg to about 400 mg of the sesame seed. In certain embodiments, the second dosage form comprises about 250 mg to about 400 mg of the sunflower seed. In certain embodiments, the first dosage form further comprises one or more selected from the group consisting of vitex, black cohosh, passionflower, hops, ladymantle, and evening primrose. In certain embodiments, the first dosage fonn comprises about 10 mg to about 20 mg of the vitex. In certain embodiments, the first dosage form comprises about 20 mg to about 40 mg of the black cohosh. In certain embodiments, the first dosage form comprises about 5 mg to about 15 mg of the passionflower. In certain embodiments, the first dosage form comprises about 5 mg to about 10 mg of the hops. In certain embodiments, the first dosage form comprises about 10 mg to about 20 mg of the ladymantle. In certain embodiments, the first dosage fonn comprises about 100 mg to 250 mg of the evening primrose. In certain embodiments, the second dosage form comprises about 250 mg to about 400 mg of the sesame seed. In certain embodiments, the second dosage form comprises about 250 mg to about 400 mg of the sunflower seed. In certain embodiments, the second dosage fonn further comprises one or more selected from the group consisting of psyllium, vitex, black cohosh, passionflower, hops, ladymantle, and evening primrose. In certain embodiments, the second dosage fonn comprises about 30 mg to about 40 mg of the psyllium. In certain embodiments, the second dosage form comprises about 10 mg to about 20 mg of the vitex. In certain embodiments, the second dosage form comprises about 20 mg to about 40 mg of the black cohosh. In certain embodiments, the first dosage form comprises about 5 mg to about 15 mg of the passionflower. In certain embodiments, the second dosage form comprises about 5 mg to about 10 mg of the hops. In certain embodiments, the second dosage form comprises about 10 mg to about 20 mg of the ladymantle. In certain embodiments, the second dosage fomi comprises about 100 mg to 250 mg of the evening primrose.

[0013] In one aspect, a method of improving hormone balance during follicular phase of menstrual cycle in a subject in need thereof is provided. The method comprises orally administering the dosage form having flaxseed, and pumpkin seed of any preceding paragraphs to the subject.

[0014] In one aspect, a method of improving hormone balance during luteal phase of menstrual cycle in a subject in need thereof is provided. The method comprises orally administering the dosage form having sesame seed, and sunflower seed of any preceding paragraphs to the subject.

[0015] In one aspect, a method of modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) in a subject in need thereof is provided. The method comprises orally administering the dosage form having flaxseed, and pumpkin seed of any preceding paragraphs during follicular phase of menstrual cycle and administering the dosage form having sesame seed, and sunflower seed of any preceding paragraphs during luteal phase of menstrual cycle.

[0016] In one aspect, a method of modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) is provided. The method comprises using the kit of any one of the preceding paragraphs to the subject.

[0017] In one aspect, a method of modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) is provided. The method comprises administering orally a first dosage form to the subject during follicular phase of menstrual cycle, and administering orally a second dosage fomi to the subject during luteal phase of menstrual cycle, the second dosage fonn. The first dosage form comprises about 300 mg to about 500 mg of flaxseed; and about 250 mg to 400 mg of pumpkin seed. The second dosage form comprises about 250 mg to about 500 mg of sesame seed, and about 250 mg to about 500 mg of sunflower seed.

[0018] In certain embodiments, the follicular phase is days 1-14 of the menstrual cycle, and the luteal phase is days 15-28 of the menstrual cycle. In certain embodiments, the first dosage fonn and the second dosage fonn are administered once daily. In certain embodiments, the first dosage form and the second dosage fonn are capsules or tablets. In certain embodiments, the first dosage fonn comprises about 300 mg to about 400 mg of the flaxseed. In certain embodiments, the first dosage form comprises about 250 mg to about 350 mg of the pumpkin seed. In certain embodiments, the second dosage form comprises about 250 mg to about 400 mg of the sesame seed. In certain embodiments, the second dosage form comprises about 250 mg to about 400 mg of the sunflower seed. In certain embodiments, the first dosage fonn further comprises one or more selected from the group consisting of vitex, black cohosh, passionflower, hops, ladymantle, and evening primrose. In certain embodiments, the first dosage form comprises about 10 mg to about 20 mg of the vitex. In certain embodiments, the first dosage form comprises about 20 mg to about 40 mg of the black cohosh. In certain embodiments, the first dosage form comprises about 5 mg to about 15 mg of the passionflower. In certain embodiments, the first dosage form comprises about 5 mg to about 10 mg of the hops. In certain embodiments, the first dosage fomi comprises about 10 mg to about 20 mg of the ladymantle. In certain embodiments, the first dosage fonncomprises about 100 mg to 250 mg of the evening primrose. In certain embodiments, the second dosage form comprises about 250 mg to about 400 mg of the sesame seed. In certain embodiments, the second dosage form comprises about 250 mg to about 400 mg of the sunflower seed. In certain embodiments, the second dosage form further comprises one or more selected from the group consisting of psyllium, vitex, black cohosh, passionflower, hops, ladymantle, and evening primrose. In certain embodiments, the second dosage form comprises about 30 mg to about 40 mg of the psyllium. In certain embodiments, the second dosage form comprises about 10 mg to about 20 mg of the vitex. In certain embodiments, the second dosage form comprises about 20 mg to about 40 mg of the black cohosh. In certain embodiments, the second dosage form comprises about 5 mg to about 15 mg of the passionflower. In certain embodiments, the second dosage form comprises about 5 mg to about 10 mg of the hops. In certain embodiments, the second dosage fonn comprises about 10 mg to about 20 mg of the ladymantle. In certain embodiments, the second dosage form comprises about 100 mg to 250 mg of the evening primrose.

[0019] In one aspect, use of the dosage form of the dosage form having flaxseed, and pumpkin seed of any preceding paragraphs for improving hormone balance during follicular phase of menstrual cycle in a subject in need thereof, is provided.

[0020] In one aspect, use of the dosage form having sesame seed, and sunflower seed of any preceding paragraphs for improving hormone balance during luteal phase of menstrual cycle in a subject in need thereof, is provided.

[0021] In one aspect, use of the kit of any of the preceding paragraphs for modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) is provided.

[0022] In one aspect, the kits of any of the preceding paragraphs, for modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) us provided.DETAILED DESCRIPTIONDefinitions

[0023] Before describing the disclosure in detail, it is to be understood that this disclosure is not limited to particular compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. As used in this specification and the appended claims, the singular forms “a”, “an’’ and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to “a molecule” optionally includes a combination of two or more such molecules, and the like.

[0024] The term ‘'about” as used herein refers to the usual error range for the respective value readily known to the skilled person in this technical field. Reference to “about” a value or parameter herein includes (and describes) embodiments that are directed to that value or parameter per se. In case of doubt, or should there be no art recognized common understanding regarding the error range for a certain value or parameter, “about” means ± 1%, 2%, 3%, 4%, 5%, 6%. 7%, 8%, 9%. or 10% of this value or parameter.

[0025] It is understood that aspects and embodiments of the disclosure described herein include “comprising,” “consisting,” and “consisting essentially of aspects and embodiments.

[0026] As used herein, “at least” refers to an amount that is 10% of the recited value and is preferably %5% of tire recited value, or more preferably %2% of the recited value.

[0027] “Premenstrual Syndrome (PMS) ” refers to a group of physical, emotional, and psychological symptoms related to a woman's menstrual cycle. These symptoms typically occur during the luteal phase, the second half of the menstrual cycle after ovulation and before menstruation starts. The exact cause of PMS is not known, but it's thought to be linked to changes in hormone levels during the menstrual cycle. Symptoms can vary widely in intensity and may include bloating, breast tenderness, mood swings, fatigue, irritability, and changes in appetite or sleep patterns. For most women, PMS symptoms are mild and manageable, but they can be severe and disruptive for some.

[0028] “Premenstrual Dysphoric Disorder (PMDD)” is a severe form of PMS that significantly interferes with a woman's daily activities and quality of life. PMDD is characterized by more intense emotional and physical symptoms that occur during the luteal phase of the menstrual cycle. The American Psychiatric Association recognizes PMDD as a distinct clinical condition. Symptoms of PMDD include severe depression, irritability, and tension before menstruation. Physical symptoms similar to PMS may also be present but are accompanied by significant emotional disturbances. The exact cause of PMDD is unknown, but it is believed to involve an abnormal reaction to hormonal changes related to the menstrual cycle, with serotonin playing a possible role in mediating mood symptoms. Diagnosis typically involves tracking symptoms over at least two menstrual cycles and assessing the impact on daily functioning.

[0029] As used herein, “seed” or “seeds”, such as “pumpkin seed”, “flaxseed”, “sesame seed”, and “sunflower seed” may refer to dried or fresh seeds, seeds in a meal form, seeds in a powder form, or extract of the seeds.

[0030] As used herein, plants such as “psyllium”, “vitex”, “black cohosh”, “passionflower”, “hops”, “ladymantle”, and “evening primrose” may refer to any parts of such plant, for example, flower, leaf, root, fruit, seed, or an extract thereof. Such plants may be further processed to have different form (e.g., powder), or to further concentrate certain nutrients.

[0031] ‘ ’Modulate” or “modulation”, as used herein refers to the process of adjusting or regulating the severity, expression, or course of a disease, such as irregular menstrual cycle.

[0032] As used herein, the terms “treat” or “treatment” refer to therapeutic treatment, wherein the object is to slow down (lessen) an undesired physiological change or disorder, such as the progression of a condition or disorder. Beneficial or desired clinical results include, but are not limited to, alleviation of symptoms, diminishment of extent of disease, stabilized (i.e., not worsening) state of disease, delay or slowing of disease progression, amelioration or palliation of the disease state, and remission (whether partial or total), whether detectable or undetectable. “Treatment” can also mean prolonging survival as compared to expected survival if not receiving treatment. Those in need of treatment include those already with the condition or disorder as well as those prone to have the condition or disorder.

[0033] The term “prevent” or “prevention” means any treatment of a disease or condition that causes the clinical symptoms of the disorder or condition not to develop.

[0034] A “disorder” is a state of health of an animal wherein the animal cannot maintain homeostasis, and wherein if the disease is not ameliorated then the animal’s health continues to deteriorate.

[0035] Tire terms “effective amount,” “pharmaceutically effective amount,” and “therapeutically effective amount” refer to an amount that may be effective to elicit the desired biological or medical response, including the amount of a compound or a polypeptide that, when administered to a subject for treating a disease, is sufficient to effect such treatment for the disease. The effective amount will vary depending on the compound or the polypeptide, the disease and its severity and the age, weight, etc., of the subject to be treated. The effective amount can include a range of amounts. A pharmaceutically effective amount includes amounts of an agent which are effective when combined with other agents.

[0036] By “subject” or “individual” or “animal” or “patient” or “mammal,” is meant any subject, particularly a mammalian subject, for whom diagnosis, prognosis, or therapy is desired. Mammalian subjects include humans, domestic animals, farm animals, and zoo, sport, or pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, cows, and so on. In certain embodiments of the present disclosure, the subject is female.

[0037] As used herein, phrases such as “to a patient in need of modulation, alleviation or treatment” or “a subject in need of modulation, alleviation or treatment'’ includes subjects, such as mammalian subjects, that would benefit from about administration of a composition of the present disclosure used, e.g.. for modulation, alleviation or treatment.Seed CompositionsSeed Composition of Flaxseed and Pumpkin Seed

[0038] The present disclosure provides a composition including flaxseed and pumpkin seed. Such composition may be referred to as “first composition” herein.

[0039] Flaxseed includes lignans, with glycosides of secoisolariciresinol and matairesinol as the major compounds. Flaxseeds may include further nutrients such as alpha-linolenic acid (ALA), dietary' fiber, plant protein, vitamins and minerals and phytochemicals.

[0040] ALA is a type of omega-3 fatty acid, contributing to the maintenance of normal blood cholesterol levels, reduces inflammation, and may lower the risk of heart disease. Unlike other types of fats, omega-3 fatty acids are polyunsaturated fats that are beneficial for heart health.

[0041] Lignans are a type of phytoestrogen, which are plant-derived compounds that can mimic or modulate tire body's own estrogen. They are found in a variety of foods, including seeds (especially flaxseeds), whole grains, fruits, and vegetables. Due to their estrogen-like activity, lignans can play a significant role in the menstrual cycle and overall reproductive health in women.

[0042] The vitamins and minerals include vitamin Bl (thiamine), magnesium, phosphorus, and selenium.

[0043] Beyond lignans. flaxseeds may also contain other phytochemicals, including phenolic acids and flavonoids. These compounds are reported to have antioxidant properties, helping to protect the body from cellular damage caused by free radicals.

[0044] In certain embodiments, the flaxseeds are derived from Linum usitatisimum L. plant and / or Linum flavum L. plant.

[0045] In certain embodiments, a composition includes the flaxseed in an amount of about 30% w / w to about70% w / w, for example, about 30% w / w to about 65% w / w, about 30% w / w to about 60% w / w, about 30% w / w to about 55% w / w, about 30% w / w to about 50% w / w, about 30% w / w to about 45% w / w, about 30% w / w to about 40% w / w, about 30% w / w to about 35% w / w, about 35% w / w to about 70% w / w, about 35% w / w to about 65% w / w, about 35% to about 60% w / w, about 35% w / w to about 55% w / w, about 35% w / w to about 50% w / w, about 35% w / w to about 45% w / w, about 35% w / w to about 40% w / w. about 40% w / w to about 70% w / w. about 40% w / w to about 65% w / w. about 40% w / w to about 60% w / w, about 40% w / w to about 55% w / w, about 40% w / w to about 50% w / w, about 40% w / w to about 45% w / w, about 45% to about 70% w / w, about 45% w / w to about 65% w / w, about 45% w / w to about 60% w / w, about 45% w / w to about 55% w / w, about 45% w / w to about 50% w / w, about 50% w / w to about 70% w / w, about 50% w / w to about 65% w / w, about 50% w / w to about 60% w / w, about 50% w / w to about 55% w / w, about 55% w / w to about 70% w / w, about 55% w / w to about 65% w / w, about 55% w / w to about 60% w / w, about 60% w / w to about 70% w / w about 60% w / w to about 65% w / w, about 65% w / w to about 70% w / w.

[0046] In certain embodiments, the flaxseed is present in an amount of about 40.0% w / w, about 40.2% w / w, about 40.4% w / w, about 40.6% w / w, about 40.8% w / w, about 41.0% w / w, about 41.2% w / w, about 41.4% w / w, about 41.6% w / w, about 41.8% w / w, about 42.0% w / w, about 42.2% w / w, about 42.4% w / w, about 42.6% w / w, about 42.8% w / w, about 43.0% w / w, about 44.0% w / w, about 45.0% w / w, about 46.0% w / w, about 47.0% w / w, about 48.0% w / w, about 49.0 % w / w, about 50.0 % w / w, about 51.0% w / w, about 52.0% w / w, about 53.0% w / w, about 54.0% w / w, about 54.2% w / w. about 54.4% w / w, about 54.6 % w / w, about 54.8% w / w, about 55.0% w / w, about 55.2% w / w, about 55.8% w / w, or about 56.0% w / w.

[0047] In certain embodiments, the flaxseed may be in any suitable fonn in the first composition. For example, the first composition may include flaxseeds in a whole seed or seed meal form. In some embodiments, the first composition may include flaxseeds in powder or granule form.

[0048] In certain embodiments, the flaxseed may be concentrated or enriched to increase content of one or more nutrients, such as alpha-linolenic acid (ALA), lignans, dietary fiber, plant protein, vitamins and minerals and / or phytochemicals. In certain embodiments, the one or more of the nutrients are concentrated to at least 2-fold, such as 2-fold, 3-fold, 4-fold. 5-fold, 6-fold, 7-fold, 8-fold. 9-fold, or 10- fold compared to unconcentrated flaxseed. In certain embodiments, the flaxseed is concentrated with 2- fold or 5-fold of the one or more nutrients.

[0049] Pumpkin seeds (Cucurbita pepo L. convar citrullina var. styriaca. Cucurbitaceae) may include various nutrients and phytochemicals, such as lignan (e.g., secoisolariciresinol), zinc, omega-3 fatty acids, magnesium, phytoestrogens and tryptophan. Phytoestrogens are reported to help balance estrogen levels in the body, potentially reducing PMS (Premenstrual Syndrome) and supporting the growth of the uterine lining during the follicular phase.

[0050] In addition, pumpkin seeds include zinc, a mineral reported to be essential for reproductive health. Zinc is reported to play a crucial role in the regulation of the menstrual cycle, supporting the development of the eggs within the ovaries, and it may help in regulating hormone levels, including FSH and estrogen, which are key honnones during the follicular phase.

[0051] Omega-3 fatty acids, which are known to help reduce inflammation and could support overall reproductive health. Omega-3s may also contribute to better hormonal balance, which is crucial for a regular and healthy menstrual cycle.

[0052] Pumpkin seeds also include magnesium, a mineral that supports hundreds of biochemical reactions in the body, including those involved in hormone regulation. Magnesium can also help alleviate menstrual cramps and improve sleep quality, which might be particularly beneficial during the preovulatory phase. Pumpkin seeds are also a natural source of tryptophan, an amino acid that the bodyconverts into serotonin and then into melatonin, the sleep hormone. Adequate sleep and stress reduction are important for maintaining hormonal balance and supporting the menstrual cycle's regularity.

[0053] In certain embodiments, the pumpkin seeds is present in an amount of about for example, about 30% w / w to about 65% w / w, about 30% w / w to about 60% w / w, about 30% w / w to about 55% w / w, about 30% w / w to about 50% w / w, about 30% w / w to about 45% w / w, about 30% w / w to about 40% w / w, about 30% w / w to about 35% w / w, about 35% w / w to about 70% w / w, about 35% w / w to about 65% w / w, about 35% to about 60% w / w, about 35% w / w to about 55% w / w, about 35% w / w to about 50% w / w, about 35% w / w to about 45% w / w, about 35% w / w to about 40% w / w, about 40% w / w to about 70% w / w, about 40% w / w to about 65% w / w, about 40% w / w to about 60% w / w, about 40% w / w to about 55% w / w, about 40% w / w to about 50% w / w, about 40% w / w to about 45% w / w, about 45% to about 70% w / w, about 45% w / w to about 65% w / w. about 45% w / w to about 60% w / w. about 45% w / w to about 55% w / w, about 45% w / w to about 50% w / w, about 50% w / w to about 70% w / w, about 50% w / w to about 65% w / w, about 50% w / w to about 60% w / w, about 50% w / w to about 55% w / w, about 55% w / w to about 70% w / w, about 55% w / w to about 65% w / w, about 55% w / w to about 60% w / w, about 60% w / w to about 70% w / w about 60% w / w to about 65% w / w, about 65% w / w to about 70% w / w.

[0054] In certain embodiments, the flaxseed is present in an amount of about 37.0% w / w, about 37.1% w / w, about 37.2% w / w, about 37.3% w / w, about 37.4% w / w, about 37.5% w / w. about 37.6% w / w, about 37.7% w / w. about 37.8% w / w, about 37.9% w / w, about 38.0% w / w, about 38.1% w / w, about 38.2% w / w. about 38.3% w / w, about 38.4% w / w, about 38.5% w / w, about 38.6% w / w, about 38.7% w / w, about 38.8% w / w, about 38.9% w / w, about 39.0% w / w, about 39. 1 % w / w, about 39.2 % w / w, about 39.3% w / w, about 39.4% w / w, about 39.5% w / w, about 39.6% w / w, about 39.7% w / w, about 39.8% w / w, about 39.9 % w / w. about 40.0% w / w, about 41.0% w / w, about 41.1% w / w, about 41.2% w / w, about 41.3% w / w, about 41.4% w / w, about 41.5% w / w, about 41.6% w / w, about 41.7% w / w. about 41.8% w / w, about 41.9% w / w, about 42.0% w / w, about 42. 1% w / w, about 42.2% w / w, about 42.3% w / w, about 42.4% w / w. about 42.5% w / w, about 42.6% w / w, about 42.7% w / w, about 42.8% w / w, about 42.9% w / w, about 43.0% w / w, about 43.1% w / w, about 43.2% w / w, about 43.4% w / w, about 43.5% w / w, about 43.6% w / w, about 43.7% w / w, about 43.8% w / w, about 43.9% w / w, about 44.0% w / w, about 44.1% w / w, about 44.2% w / w, about 44.3% w / w, about 44.4% w / w, about 44.5% w / w, about 44.6% w / w, about 44.7% w / w, about 44.8% w / w, about 44.9% w / w, about 45.0% w / w, or about 50.0% w / w.

[0055] In certain embodiments, the pumpkin seed may be in any suitable form in the first composition. For example, the first composition may include pumpkin seed in a whole seed or seed meal form. In some embodiments, the first composition may include pumpkin seed in powder or granule form.

[0056] In certain embodiments, the pumpkin seed is concentrated or enriched to increase content of one or more nutrients, such as lignan (e.g. secoisolariciresinol), zinc, omega-3 fatty acids, magnesium,phytoestrogens and / or tryptophan. In certain embodiments, the one or more of the nutrients are concentrated to at least 2-fold, such as 2-fold, 3-fold, 4-fold, 5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10- fold compared to unconcentrated pumpkin seed. In certain embodiments, the pumpkin seed is concentrated with 2-fold or 5 -fold of the one or more nutrients.

[0057] The first composition of the present disclosure may further include other supplements, such as one or more selected from vitex (Vitex agnus-caslus). black cohosh (Actaea racemosa, formerly known as Cimicifuga racemosa), passionflower (Passiflora incamata), hops (Humulus lupulus), ladymantle (Alchemilla vulgaris), evening primrose (Oenothera biennis), or extract of aforementioned plants.

[0058] Vitex (Vitex agnus-castus), also known as chasteberry, is a plant native to the Mediterranean region and parts of Asia, and has been reported to have the efficacy of chasteberry in managing PMS symptoms. The first composition may include the vitex or its extract in any suitable form, such as powder. In certain embodiments, the first composition may include vitex or its extract in an amount of about 1% w / w to about 5% w / w, such as about 1.2% w / w to about 3.5% w / w, about 1.2% w / w to about 3% w / w, about 1.2% w / w to about 2.7% w / w, about 1.4% w / w to about 3% w / w, or about 1.4% w / w to about 2.7% w / w. In certain embodiments, the vitex is present in an amount of about 1.4% w / w, about 2.7% w / w, or about 2.8% w / w.

[0059] Black cohosh (Actaea racemosa, formerly known as Cimicifuga racemosa) has been widely used as a dietary supplement for women's health issues, especially those related to menopause and menstrual discomfort. The first composition may include the black cohosh or its extract in any suitable form, such as powder. In certain embodiments, the first composition may include black cohosh in an amount of about 2% w / w to about 7% w / w, such as about 2% w / w to about 6% w / w, about 2% w / w to about 5.5% w / w, about 2.5% w / w to about 6% w / w, or about 2.7% w / w to about 5.5% w / w. In certain embodiments, the first composition may include black cohosh in an amount of about 2.7% w / w, 4.1% w / w, or 5.5% w / w.

[0060] In certain embodiments, the first composition includes the passionflower or its extract in an amount of about 0.5% w / w to about 2% w / w, such as about 1% w / w to about 2% w / w, about 0.5% w / w to about 2% w / w, or about 1% w / w to about 1.5% w / w. In certain embodiments, the first composition includes the passionflower or its extract in an amount of about 1.4% w / w.

[0061] In certain embodiments, the first composition includes the hops in an amount of about 0.5% w / w to about 2% w / w, such as about 1% w / w to about 2% w / w, about 0.5% w / w to about 2% w / w, about 0.5% w / w to about 1.5 % w / w, or about 1% w / w to aboutl .5% w / w. In certain embodiments, the first composition includes the hops in an amount of about 0.7% w / w or 1.4% w / w.

[0062] Ladymantle or Lady’s mantle (Alchemilla vulgaris), is a perennial herb found across Europe, Greenland, and parts of North America and Asia. Lady's mantle has been valued in traditional medicine for centuries, particularly for its uses in women's health, hence the name. It has been employed to ease menstrual cramps, reduce heavy menstrual bleeding, and aid in childbirth. Beyond its uses in women's health, it has also been applied to treat gastrointestinal issues, wounds, and skin irritations, thanks to its astringent properties.

[0063] In certain embodiments, the ladymantle is present in an amount of about 0.5% w / w to about 3.5% w / w, such as about 0.5% w / w to about 3% w / w. about 1% w / w to about 3.5% w / w, about 1% w / w to about 3 % w / w, or about 1.4% w / w to about 3% w / w. In certain embodiments, the ladymantle is present in an amount of about 1.4% w / w or 2.8% w / w.

[0064] Evening primrose (Oenothera biennis) is a plant native to North and South America but has since spread to Europe and parts of Asia. It's well-known for its yellow flowers, which typically open in the evening, hence its name. The seeds of the evening primrose plant are used to produce evening primrose oil, a substance that has garnered interest for its potential health benefits. Evening primrose oil is rich in gamma-linolenic acid (GLA), a type of omega-6 fatty acid that plays a crucial role in the body's inflammatory and immune responses.

[0065] In certain embodiments, the evening primrose is present in an amount of about 10% w / w to about 40% w / w, such as about 15% w / w to about 40% w / w, about 10% w / w to about 35% w / w, or about 15% w / w to about 35% w / w. In certain embodiments, the evening primrose is present in an amount of about 17.2% w / w or 34.5% w / w.

[0066] In certain embodiments, the first composition of the present disclosure may include about 55.2% w / w flaxseed, and about 44.8% w / w pumpkin seed.

[0067] In certain embodiments, the first composition of the present disclosure may include about 55.2% w / w flaxseed, and about 44.8% w / w pumpkin seed, wherein the one or more nutrients of flaxseed and the one or more nutrients of pumpkin seed are concentrated to 2 folds or 5 folds.

[0068] In certain embodiments, the first composition of the present disclosure may include about 50% w / w flaxseed, and about 50% w / w pumpkin seed, wherein the one or more nutrients of flaxseed and the one or more nutrients of pumpkin seed are concentrated to 2 folds or 5 folds.

[0069] In certain embodiments, the first composition of the present disclosure may include about 55.2% w / w flaxseed, about 43.4% w / w pumpkin seed and about 1.4% w / w vitex.

[0070] In certain embodiments, the first composition of the present disclosure may include about 55.2% w / w flaxseed, about 42. 1% w / w pumpkin seed and about 2.7% w / w vitex.

[0071] In certain embodiments, the first composition of the present disclosure may include about 55.2% w / w flaxseed, about 43.4% w / w pumpkin seed, and about 1.4% w / w vitex, wherein the one or more nutrients of flaxseed and the one or more nutrients of pumpkin seed are concentrated to 2 folds.

[0072] In certain embodiments, the first composition of the present disclosure may include about 55.2% w / w flaxseed, about 39.3% w / w pumpkin seed and about 5.5% w / w black cohosh.

[0073] In certain embodiments, the first composition of the present disclosure may include about 55.2% w / w flaxseed, about 37.9% w / w pumpkin seed, about 4.1% w / w black cohosh, about 1.4% w / w passionflower and about 1.4% w / w hops.

[0074] In certain embodiments, the first composition of the present disclosure may include about 54.8% w / w flaxseed, about 39 % w / w pumpkin seed, about 2.7% w / w black cohosh, about 1.4% w / w passionflower, about 0.7% w / w hops and about 1.4% w / w ladymantle.

[0075] In certain embodiments, the first composition of the present disclosure may include about 41.4% w / w flaxseed, about 41.4 % w / w pumpkin seed, and about 17.2% w / w evening primrose.Seed Composition of Sesame Seed and Sunflower Seed

[0076] The present disclosure provides a second composition including sesame seed and sunflower seed.

[0077] Sesame seeds contain fatty acids, vitamin B6, magnesium and calcium, lignans and phytoestrogen. Sesame seeds are rich in essential fatty acids, particularly omega-6 fatty acids, which can help support the body's production of prostaglandins. Prostaglandins are hormone-like substances that play a role in regulating the menstrual cycle including tire shedding of the uterine lining during menstruation.

[0078] Vitamin B6 (pyridoxine) is reported to play a role in the synthesis of neurotransmitters and can help in managing symptoms of PMS. Vitamin B6 can also support the proper metabolism of estrogen and progesterone, helping to maintain a healthy balance during the luteal phase.

[0079] In certain embodiments, the sesame seeds are derived from Sesamum indicum plant.

[0080] In certain embodiments, the sesame seed is present in an amount of about 30% w / w to about 70% w / w, for example, about 30% w / w to about 65% w / w, about 30% w / w to about 60% w / w, about 30% w / w to about 55% w / w, about 30% w / w to about 50% w / w, about 30% w / w to about 45% w / w, about 30% w / w to about 40% w / w, about 30% w / w to about 35% w / w, about 35% w / w to about 70% w / w, about 35% w / w to about 65% w / w, about 35% to about 60% w / w, about 35% w / w to about 55% w / w, about 35% w / w to about 50% w / w, about 35% w / w to about 45% w / w, about 35% w / w to about 40% w / w,about 40% w / w to about 70% w / w, about 40% w / w to about 65% w / w, about 40% w / w to about 60% w / w, about 40% w / w to about 55% w / w, about 40% w / w to about 50% w / w, about 40% w / w to about 45% w / w, about 45% to about 70% w / w, about 45% w / w to about 65% w / w, about 45% w / w to about 60% w / w, about 45% w / w to about 55% w / w, about 45% w / w to about 50% w / w, about 50% w / w to about 70% w / w, about 50% w / w to about 65% w / w, about 50% w / w to about 60% w / w. about 50% w / w to about 55% w / w, about 55% w / w to about 70% w / w, about 55% w / w to about 65% w / w, about 55% w / w to about 60% w / w, about 60% w / w to about 70% w / w about 60% w / w to about 65% w / w, about 65% w / w to about 70% w / w.

[0081] In certain embodiments, the sesame seed is present in an amount of about 40.0% w / w, about 40.2% w / w, about 40.4% w / w, about 40.6% w / w, about 40.8% w / w, about 41.0% w / w, about 41.2% w / w, about 41.4% w / w, about 41.6% w / w, about 41.8% w / w, about 42.0% w / w, about 42.2% w / w, about 42.4% w / w, about 42.6% w / w, about 42.8% w / w, about 43.0% w / w, about 44.0% w / w, about 45.0% w / w, about 46.0% w / w, about 47.0% w / w, about 48.0% w / w, about 49.0 % w / w, about 50.0 % w / w, about 51.0% w / w, about 52.0% w / w, about 53.0% w / w, about 54.0% w / w, about 54.2% w / w, about 54.4% w / w, about 54.6 % w / w, about 54.8% w / w, about 55.0% w / w, about 55.2% w / w, about 55.8% w / w, or about 56.0% w / w.

[0082] In certain embodiments, the sesame seed is sesame seed meal. In certain embodiments, the sesame seed is sesame seed powder.

[0083] In certain embodiments, the sesame seed is concentrated or enriched to increase one or more nutrients, such as fatty acids, vitamin B6, magnesium and calcium, lignans and / or phytoestrogen. In certain embodiments, the one or more of the nutrients are concentrated to at least 2-fold, such as 2-fold, 3- fold. 4-fold, 5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold. In certain embodiments, the sesame seed is concentrated with 2-fold or 5 -fold of the one or more nutrients.

[0084] Sunflower seeds are rich in various nutrients that are beneficial for hormonal balance and overall reproductive health, including lignans, vitamin E, selenium, essential fatty acids, and magnesium.

[0085] Vitamin E is a powerfol antioxidant that plays a crucial role in hormonal balance. It can help regulate the production of estrogen and progesterone; the key honnones involved in the luteal phase. Adequate levels of Vitamin E can support the proper functioning of the luteal phase, potentially reducing PMS symptoms and supporting overall menstrual health. Selenium is another antioxidant that supports the immune system and thyroid health, both of which can influence menstrual health. Thyroid hormones interact closely with reproductive hormones, so maintaining thyroid health is essential for a regular menstrual cycle. Sunflower seeds are a good source of linoleic acid, an omega-6 fatty acid, which can influence prostaglandin production. Prostaglandins are lipid compounds that have hormone-like effects and play a role in regulating the menstrual cycle. Magnesium plays a vital role in muscle relaxation andnerve function. Adequate magnesium levels can contribute to a smoother luteal phase by reducing cramping and improving mood, potentially easing symptoms of PMS.

[0086] In certain embodiments, the sunflower seeds are derived from Helianthus annuus plant.

[0087] In certain embodiments, the sunflower seed is present in an amount of about 30% w / w to about70% w / w, for example, about 30% w / w to about 65% w / w, about 30% w / w to about 60% w / w, about 30% w / w to about 55% w / w, about 30% w / w to about 50% w / w, about 30% w / w to about 45% w / w, about 30% w / w to about 40% w / w, about 30% w / w to about 35% w / w, about 35% w / w to about 70% w / w, about 35% w / w to about 65% w / w, about 35% to about 60% w / w, about 35% w / w to about 55% w / w, about 35% w / w to about 50% w / w, about 35% w / w to about 45% w / w, about 35% w / w to about 40% w / w, about 40% w / w to about 70% w / w, about 40% w / w to about 65% w / w, about 40% w / w to about 60% w / w, about 40% w / w to about 55% w / w, about 40% w / w to about 50% w / w, about 40% w / w to about 45% w / w, about 45% to about 70% w / w, about 45% w / w to about 65% w / w, about 45% w / w to about 60% w / w, about 45% w / w to about 55% w / w, about 45% w / w to about 50% w / w, about 50% w / w to about 70% w / w, about 50% w / w to about 65% w / w, about 50% w / w to about 60% w / w, about 50% w / w to about 55% w / w, about 55% w / w to about 70% w / w, about 55% w / w to about 65% w / w, about 55% w / w to about 60% w / w, about 60% w / w to about 70% w / w about 60% w / w to about 65% w / w, about 65% w / w to about 70% w / w.

[0088] In certain embodiments, the sunflower seeds is present in an amount of about 37.0% w / w. about 37.1% w / w, about 37.2% w / w, about 37.3% w / w, about 37.4% w / w, about 37.5% w / w, about 37.6% w / w, about 37.7% w / w, about 37.8% w / w, about 37.9% w / w, about 38.0% w / w, about 38.1% w / w, about 38.2% w / w, about 38.3% w / w, about 38.4% w / w, about 38.5% w / w, about 38.6% w / w, about 38.7% w / w, about 38.8% w / w, about 38.9% w / w, about 39.0% w / w, about 39. 1 % w / w, about 39.2 % w / w, about 39.3% w / w, about 39.4% w / w, about 39.5% w / w, about 39.6% w / w, about 39.7% w / w, about 39.8% w / w, about 39.9 % w / w, about 40.0% w / w, about 41.0% w / w. about 41.1% w / w, about 41.2% w / w. about 41.3% w / w, about 41.4% w / w, about 41.5% w / w, about 41.6% w / w, about 41.7% w / w, about 41.8% w / w, about 41.9% w / w, about 42.0% w / w, about 42. 1% w / w, about 42.2% w / w, about 42.3% w / w, about 42.4% w / w, about 42.5% w / w, about 42.6% w / w, about 42.7% w / w, about 42.8% w / w, about 42.9% w / w, about 43.0% w / w, about 43.1% w / w, about 43.2% w / w, about 43.4% w / w, about 43.5% w / w, about 43.6% w / w, about 43.7% w / w, about 43.8% w / w, about 43.9% w / w, about 44.0% w / w, about 44. 1% w / w, about 44.2% w / w. about 44.3% w / w, about 44.4% w / w. about 44.5% w / w, about 44.6% w / w. about 44.7% w / w, about 44.8% w / w, about 44.9% w / w, about 45.0% w / w, or about 50.0% w / w.

[0089] In certain embodiments, the sunflower seed may be in any suitable form in the second composition. For example, the first composition may include sunflower seed in a whole seed or seed meal form. In some embodiments, the first composition may include sunflower in powder or granule form.

[0090] In certain embodiments, the sunflower seed is concentrated or enriched to increase one or more nutrients, such as lignans, vitamin E, selenium, essential fatty acids, and / or magnesium. In certain embodiments, the one or more of the nutrients are concentrated to at least 2-fold, such as 2-fold, 3-fold, 4- fold, 5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold. In certain embodiments, the sunflower seed is concentrated with 2-fold or 5 -fold of the one or more nutrients.

[0091] Tire second composition of the present disclosure may include further supplements, such as psyllium, vitex, black cohosh, passionflower, hops, ladymantle, and / or evening primrose.

[0092] Psyllium (Plantago ovata), is a form of fiber derived from the husks of the plant's seeds. It's widely used as a dietary supplement for its excellent source of soluble fiber. Psyllium is particularly recognized for its ability to absorb water, turning into a thick, viscous compound that benefits the digestive system in several ways.

[0093] In certain embodiments, the psyllium is present in an amount of about 4% w / w to about 7% w / w, such as about 4% w / w to about 6.5% w / w, about 4% w / w to about 6% w / w, or about 4% w / w to about 5.5% w / w. In certain embodiments, the psyllium is present in an amount of about 4.1% w / w or about 5.5% w / w.

[0094] In certain embodiments, the vitex is present in an amount of about 1% w / w to about 5% w / w, such as about 1.2% w / w to about 3.5% w / w, about 1.2% w / w to about 3% w / w, about 1.2% w / w to about 2.7% w / w, about 1.4% w / w to about 3% w / w, or about 1.4% w / w to about 2.7% w / w. In certain embodiments, the vitex is present in an amount of about 1.4% w / w, about 2.7% w / w, or about 2.8% w / w.

[0095] In certain embodiments, the black cohosh is present in an amount of about 2% w / w to about 7% w / w, such as about 2% w / w to about 6% w / w. about 2% w / w to about 5.5% w / w, about 2.5% w / w to about 6% w / w, or about 2.7% w / w to about 5.5% w / w. In certain embodiments, the black cohosh is present in an amount of about 2.7% w / w, 4.1% w / w, or 5.5% w / w.

[0096] In certain embodiments, the passionflower is present in an amount of about 0.5% w / w to about 2% w / w, such as about 1% w / w to about 2% w / w, about 0.5% w / w to about 2% w / w, or about 1% w / w to about 1.5% w / w. In certain embodiments, the passionflower is present in an amount of about 1.4% w / w.

[0097] In certain embodiments, the hops is present in an amount of about 0.5% w / w to about 2% w / w, such as about 1% w / w to about 2% w / w, about 0.5% w / w to about 2% w / w, or about 1% w / w to about 1.5% w / w. In certain embodiments, tire hops is present in an amount of about 0.7% w / w or 1.4% w / w.

[0098] In certain embodiments, the ladymantle is present in an amount of about 0.5% w / w to about 3.5% w / w, such as about 0.5% w / w to about 3% w / w, about 1% w / w to about 3.5% w / w, about 1% w / w toabout 3 % w / w, or about 1.4% w / w to about 3% w / w. In certain embodiments, the ladymantle is present in an amount of about 1.4% w / w.

[0099] In certain embodiments, the evening primrose is present in an amount of about 10% w / w to about 25% w / w, such as about 15% w / w to about 25% w / w, about 10% w / w to about 20% w / w, or about 15% w / w to about 20% w / w. In certain embodiments, the evening primrose is present in an amount of about 17.2% w / w.

[0100] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 37.9% w / w sunflower seed, about 5.5% w / w psyllium and about 1.4% w / w vitex.

[0101] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 43.4% w / w sunflower seed, and about 1.4% w / w vitex.

[0102] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 42.1% w / w sunflower seed, and about 2.7% w / w vitex.

[0103] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, and about 44.8% w / w sunflower seed, wherein the one or more nutrients of sesame seed and the one or more nutrients of sunflower seed are concentrated to 2 folds or 5 folds.

[0104] In certain embodiments, the second composition of the present disclosure may include about 50% w / w sesame seed, and about 50% w / w sunflower seed, wherein the one or more nutrients of sesame seed and the one or more nutrients of sunflower seed are concentrated to 2 folds or 5 folds.

[0105] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 37.9% w / w sunflower seed, about 5.5% w / w psyllium and 1.4% w / w vitex.

[0106] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 37.9% w / w sunflower seed, about 4.1% w / w psyllium and 2.8% w / w vitex.

[0107] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 43.4% w / w sunflower seed, and about 1.4% w / w vitex.

[0108] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 42.1% w / w sunflower seed, and about 2.7% w / w vitex.

[0109] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 43.4% w / w sunflower seed, and about 1 .4% w / w vitex, wherein the one or more nutrients of sesame seed and the one or more nutrients of sunflower seed are concentrated to 2 folds.

[0110] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 39.3% w / w sunflower seed and about 5.5% w / w black cohosh.[OHl] In certain embodiments, the second composition of the present disclosure may include about 55.2% w / w sesame seed, about 37.9% w / w sunflower seed, about 4.1% w / w black cohosh, about 1.4% w / w passionflower and about 1.4% w / w hops.

[0112] In certain embodiments, the second composition of the present disclosure may include about 54.8% w / w sesame seed, about 39 % w / w sunflower seed, about 2.7% w / w black cohosh, about 1.4% w / w passionflower, about 0.7% w / w hops and about 1.4% w / w ladymantle.

[0113] In certain embodiments, the second composition of the present disclosure may include about 41.4% w / w sesame seed, about 41.4 % w / w sunflower seed, and about 17.2% w / w evening primrose.

[0114] The present disclosure also provides a kit including the first composition and the second composition.

[0115] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, and about 44.8% w / w pumpkin seed; and the second composition comprises about 55.2% w / w sesame seed, about 37.9% w / w sunflower seed, about 5.5% w / w psyllium and about 1.4% w / w vitex.

[0116] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, and about 44.8% w / w pumpkin seed; and the second composition comprises about 55.2% w / w sesame seed, about 43.4% w / w sunflower seed, and about 1 .4% w / w vitex.

[0117] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, and about 44.8% w / w pumpkin seed; and the second composition comprises about 55.2% w / w sesame seed, about 42.1% w / w sunflower seed, and about 2.8% w / w vitex.

[0118] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, and about 44.8% w / w pumpkin seed, wherein the one or more nutrients of flaxseed and the one or more nutrients of pumpkin seed are concentrated to 2 folds; and the second composition comprises about 55.2% w / w sesame seed, and about 44.8% w / w sunflower seed, wherein the one or more nutrients of sesame seed and the one or more nutrients of sunflower seed are concentrated to 2 folds.

[0119] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, and about 44.8% w / w pumpkin seed, wherein the one or more nutrients of flaxseed and the one or more nutrientsof pumpkin seed are concentrated to 5 folds; and the second composition comprises about 55.2% w / w sesame seed, and about 44.8% w / w sunflower seed, wherein the one or more nutrients of sesame seed and the one or more nutrients of sunflower seed are concentrated to 5 folds.

[0120] In certain embodiments, the first composition comprises about 50% w / w flaxseed, and about 50% w / w pumpkin seed, w herein the one or more nutrients of flaxseed and the one or more nutrients of pumpkin seed are concentrated to 2 folds; and the second composition comprises about 50% w / w sesame seed, and about 50% w / w sunflower seed, wherein the one or more nutrients of sesame seed and the one or more nutrients of sunflower seed are concentrated to 2 folds.

[0121] In certain embodiments, the first composition comprises about 50% w / w flaxseed, and about 50% w / w pumpkin seed, wherein the one or more nutrients of flaxseed and the one or more nutrients of pumpkin seed are concentrated to 5 folds; and the second composition comprises about 50% w / w sesame seed, and about 50% w / w sunflower seed, wherein the one or more nutrients of sesame seed and the one or more nutrients of sunflower seed are concentrated to 5 folds.

[0122] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, about 42. 1% w / w pumpkin seed and about 2.7% w / w vitex; and the second composition comprises about 55.2% w / w sesame seed, about 37.9% w / w sunflower seed, about 4.1% w / w psyllium and 2.8% w / w vitex.

[0123] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, about 43.4% w / w pumpkin seed and about 1.4% w / w vitex: and the second composition comprises about 55.2% w / w sesame seed, about 43.4% w / w sunflower seed, and about 1.4% w / w vitex.

[0124] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, about 42. 1% w / w pumpkin seed and about 2.7% w / w vitex: and the second composition comprises about 55.2% w / w sesame seed, about 42.1 % w / w sunflower seed, and about 2.7% w / w vitex.

[0125] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, about 43.4% w / w pumpkin seed, wherein the one or more nutrients of flaxseed and the one or more nutrients of pumpkin seed are concentrated to 2 folds, and about 1.4% w / w vitex; and the second composition comprises about 55.2% w / w sesame seed, about 43.4% w / w sunflower seed, and about 1.4% w / w vitex, wherein the one or more nutrients of sesame seed and die one or more nutrients of sunflower seed are concentrated to 2 folds.

[0126] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, about 39.3% w / w pumpkin seed and about 5.5% w / w black cohosh; and the second composition comprises about 55.2% w / w sesame seed, about 39.3% w / w sunflower seed and about 5.5% w / w black cohosh.

[0127] In certain embodiments, the first composition comprises about 55.2% w / w flaxseed, about 37.9% w / w pumpkin seed, about 4.1% w / w black cohosh, about 1.4% w / w passionflower and about 1.4% w / w hops; and the second composition comprises about 55.2% w / w sesame seed, about 37.9% w / w sunflower seed, about 4.1% w / w black cohosh, about 1.4% w / w passionflower and about 1.4% w / w hops.

[0128] In certain embodiments, the first composition comprises about 54.8% w / w flaxseed, about 39 % w / w pumpkin seed, about 2.7% w / w black cohosh, about 1.4% w / w passionflower, about 0.7% w / w hops and about 1.4% w / w ladymantle; and the second composition comprises about 54.8% w / w sesame seed, about 39 % w / w sunflower seed, about 2.7% w / w black cohosh, about 1.4% w / w passionflower, about 0.7% w / w hops and about 1.4% w / w ladymantle.

[0129] In certain embodiments, the first composition comprises about 41.4% w / w flaxseed, about 41.4 % w / w pumpkin seed, and the second composition comprises about 17.2% w / w evening primrose; about 41.4% w / w sesame seed, about 41.4 % w / w sunflower seed, and about 17.2% w / w evening primrose.

[0130] The first composition and / or the second composition of the present disclosure can be in a suitable dosage form, such as capsule or tablet. In certain embodiments, the first composition and / or the second composition of the present disclosure is in a dosage form of capsule.

[0131] In certain embodiments, the first composition and / or the second composition of the present disclosure is coated with materials such as hydroxypropyl methylcellulose (HPMC), pullulan. carrageenan, gellan gum, and enteric coatings.

[0132] In certain embodiments, the first composition and / or the second composition of the present disclosure may be coated with capsules, such as “00” veggie capsules.Third Composition

[0133] In certain embodiments, another composition of the present disclosure (“third composition” herein) may include about 55.2% w / w flaxseed, about 5.5% w / w black cohosh, about 1.4% w / w passionflower, about 0.7% w / w hops, about 2.7% w / w ladymantle and about 34.5% w / w evening primrose.Dosage

[0134] In certain embodiments, the first composition and / or the second composition of the present disclosure entails a unit dosage from about 500mg to 3000mg, such as from about 500mg to 2950mg, from about 500mg to 2900mg, from about 500mg to 2500mg. from about 500mg to 2000mg, from about 500mg to 1500mg, from about 500mg to 1400mg, from about 500mg to 1300mg, from about 500mg to 1200mg, from about 500mg to 1 lOOmg, from about 500mg to lOOOmg, from about 600mg to lOOOmg, from about 700mg to lOOOmg, from about 700mg to 900mg, from about 700mg to 800mg, from about700mg to 750mg. In certain embodiments, the first composition and / or the second composition of the present disclosure entails a unit dosage of 720 mg, 725 mg, 730 mg, 1440 mg, 1450 mg or 1460 mg.

[0135] In certain embodiments, the first composition and the second composition are in a unit dosage fomi, such as capsules or tablets. By having a unit dosage form, such as capsules or tablets, one can simply consume a fixed dose of seeds each time, and the dose can be easily controlled. Further, contamination of composition is prevented.Dosage Form Including Flaxseed and Pumpkin Seed

[0136] In some embodiments, a first dosage form includes about 200 mg to about 1000 mg of flaxseed and about 200 mg to about 800 mg of pumpkin seed. For example, the dosage form may include about 300 mg to about 500 mg of flaxseed and about 250 mg to about 400 mg of pumpkin seed.

[0137] Tire first dosage form may include the flaxseed in an amount of about 250 mg to about 1000 mg, about 250 mg to about 900 mg, about 250 mg to about 800 mg, about 250 mg to about 700 mg, about 250 mg to about 600 mg, about 250 mg to about 500 mg, about 250 mg to about 450 mg, about 250 mg to about 400 mg. about 250 mg to about 350 mg. about 250 mg to about 300 mg. about 300 mg to about 1000 mg, about 300 mg to about 900 mg, about 300 mg to about 800 mg, about 300 mg to about 700 mg, about 300 mg to about 600 mg, about 300 mg to about 500 mg, about 300 mg to about 300 mg, about 300 mg to about 400 mg, about 300 mg to about 350 mg, about 350 mg to about 1000 mg, about 350 mg to about 900 mg, about 350 mg to about 800 mg. about 350 mg to about 700 mg. about 350 mg to about 600 mg, about 350 mg to about 500 mg, about 350 mg to about 450 mg, about 350 mg to about 400 mg, about 400 mg to about 1000 mg. about 400 mg to about 900 mg. about 400 mg to about 800 mg, about 400 mg to about 700 mg, about 400 mg to about 600 mg, about 400 mg to about 500 mg, about 400 mg to about 450 mg, about 500 mg to about 1000 mg, about 500 mg to about 900 mg, about 500 mg to about 800 mg, about 500 mg to about 700 mg, about 500 mg to about 600 mg, about 600 mg to about 1000 mg, about 600 mg to about 900 mg, about 600 mg to about 800 mg, about 600 mg to about 700 mg. In some embodiments, the dosage form may include the flaxseed in an amount of about 250 mg, about 300 mg, about 350 mg. about 400 mg, about 450 mg. about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 900 mg, or about 1000 mg.

[0138] The first dosage form may include the pumpkin seed in an amount of about 250 mg to about 1000 mg, about 250 mg to about 900 mg, about 250 mg to about 800 mg, about 250 mg to about 700 mg, about 250 mg to about 600 mg, about 250 mg to about 500 mg, about 250 mg to about 450 mg, about 250 mg to about 400 mg. about 250 mg to about 350 mg. about 250 mg to about 300 mg. about 300 mg to about 1000 mg, about 300 mg to about 900 mg, about 300 mg to about 800 mg, about 300 mg to about 700 mg. about 300 mg to about 600 mg, about 300 mg to about 500 mg, about 300 mg to about 300 mg, about 300 mg to about 400 mg, about 300 mg to about 350 mg, about 350 mg to about 1000 mg, about 350 mg toabout 900 mg, about 350 mg to about 800 mg, about 350 mg to about 700 mg, about 350 mg to about 600 mg, about 350 mg to about 500 mg, about 350 mg to about 450 mg, about 350 mg to about 400 mg, about 400 mg to about 1000 mg, about 400 mg to about 900 mg, about 400 mg to about 800 mg, about 400 mg to about 700 mg, about 400 mg to about 600 mg, about 400 mg to about 500 mg, about 400 mg to about 450 mg, about 500 mg to about 1000 mg, about 500 mg to about 900 mg, about 500 mg to about 800 mg, about 500 mg to about 700 mg, about 500 mg to about 600 mg, about 600 mg to about 1000 mg, about 600 mg to about 900 mg, about 600 mg to about 800 mg, or about 600 mg to about 700 mg. In some embodiments, the dosage form may include the pumpkin seed in an amount of about 250 mg, about 275 mg, about 285 mg, about 300 mg, about 305 mg, about 315 mg, about 325 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 900 mg, or about 1000 mg.

[0139] In some embodiments, the first dosage form further includes one or more selected from the group consisting of vitex, black cohosh, passionflower, hops, ladymantle, and evening primrose.

[0140] For example, the first dosage form may include comprises about 5 mg to about 100 mg. about 5 mg to about 30 mg, or about 10 mg to about 20 mg of the vitex. In some embodiments, the first dosage form includes about 10 mg or about 20 mg of the vitex.

[0141] The first dosage form may include about 10 mg to about 100 mg, about 10 mg to about 50 mg, about 20 mg to about 40 mg, or about 30 mg to about 40 mg of the black cohosh. In some embodiments, the first dosage fomi includes about 10 mg, about 20 mg, about 30 mg, or about 40 mg of the black cohosh.

[0142] Tire first dosage form may include about 5 mg to about 50 mg, about 5 mg to about 20 mg, or about 5 mg to about 15 mg of the passionflower. In some embodiments, the first dosage form includes about 5 mg, about 10 mg, or about 15 mg of the passionflower.

[0143] The first dosage form may include about 5 mg to about 50 mg, about 5 mg to about 20 mg, or about 5 mg to about 10 mg of the hops. In some embodiments, the first dosage form includes about 5 mg, about 10 mg, or about 20 mg of the hops.

[0144] The first dosage form may include about 5 mg to about 50 mg, about 5 mg to about 20 mg, or about 10 mg to about 20 mg of the ladymantle. In some embodiments, the first dosage form includes about 5 mg, 10 mg, 15 mg, or 20 mg of the ladymantle.

[0145] The first dosage form may include about 10 mg to about 300 mg, about 100 mg to about 250 mg, about 125 mg to about 250 mg, or about 100 mg to about 200 mg of the evening primrose. In someembodiments, the first dosage form includes about 100 mg, about 125 mg, about 150 mg, about 200 mg, or about 250 mg of the evening primrose.Dosage Form Including Sesame Seed and Sunflower Seed

[0146] In some embodiments, a second dosage form includes about 200 mg to about 1000 mg of sesame seed and about 200 mg to about 800 mg of sunflower seed. For example, the dosage form may include about 250 mg to about 500 mg of the sesame seed and about 250 mg to about 500 mg of the sunflower seed.

[0147] The second dosage form may include the sesame seed in an amount of about 250 mg to about 1000 mg, about 250 mg to about 900 mg, about 250 mg to about 800 mg, about 250 mg to about 700 mg, about 250 mg to about 600 mg, about 250 mg to about 500 mg, about 250 mg to about 450 mg, about 250 mg to about 400 mg, about 250 mg to about 350 mg, about 250 mg to about 300 mg, about 300 mg to about 1000 mg, about 300 mg to about 900 mg, about 300 mg to about 800 mg, about 300 mg to about 700 mg, about 300 mg to about 600 mg, about 300 mg to about 500 mg. about 300 mg to about 300 mg. about 300 mg to about 400 mg, about 300 mg to about 350 mg, about 350 mg to about 1000 mg, about 350 mg to about 900 mg, about 350 mg to about 800 mg, about 350 mg to about 700 mg, about 350 mg to about 600 mg, about 350 mg to about 500 mg, about 350 mg to about 450 mg, about 350 mg to about 400 mg, about 400 mg to about 1000 mg, about 400 mg to about 900 mg, about 400 mg to about 800 mg, about 400 mg to about 700 mg, about 400 mg to about 600 mg, about 400 mg to about 500 mg, about 400 mg to about 450 mg, about 500 mg to about 1000 mg, about 500 mg to about 900 mg. about 500 mg to about 800 mg. about 500 mg to about 700 mg. about 500 mg to about 600 mg. about 600 mg to about 1000 mg, about 600 mg to about 900 mg, about 600 mg to about 800 mg, about 600 mg to about 700 mg. In some embodiments, the dosage form may include tire sesame seed in an amount of about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg. about 800 mg, about 900 mg, or about 1000 mg.

[0148] The second dosage form may include the sunflower seed in an amount of about 250 mg to about 1000 mg, about 250 mg to about 900 mg, about 250 mg to about 800 mg, about 250 mg to about 700 mg, about 250 mg to about 600 mg, about 250 mg to about 500 mg, about 250 mg to about 450 mg, about 250 mg to about 400 mg, about 250 mg to about 350 mg, about 250 mg to about 300 mg, about 300 mg to about 1000 mg, about 300 mg to about 900 mg, about 300 mg to about 800 mg, about 300 mg to about 700 mg, about 300 mg to about 600 mg, about 300 mg to about 500 mg, about 300 mg to about 300 mg. about 300 mg to about 400 mg, about 300 mg to about 350 mg, about 350 mg to about 1000 mg, about 350 mg to about 900 mg, about 350 mg to about 800 mg, about 350 mg to about 700 mg, about 350 mg to about 600 mg, about 350 mg to about 500 mg, about 350 mg to about 450 mg, about 350 mg to about 400 mg, about 400 mg to about 1000 mg, about 400 mg to about 900 mg, about 400 mg to about 800 mg,about 400 mg to about 700 mg, about 400 mg to about 600 mg, about 400 mg to about 500 mg, about 400 mg to about 450 mg, about 500 mg to about 1000 mg, about 500 mg to about 900 mg, about 500 mg to about 800 mg, about 500 mg to about 700 mg, about 500 mg to about 600 mg, about 600 mg to about 1000 mg, about 600 mg to about 900 mg, about 600 mg to about 800 mg, or about 600 mg to about 700 mg. In some embodiments, the dosage form may include the sunflower seed in an amount of about 250 mg, about 275 mg, about 285 mg, about 300 mg, about 305 mg. about 315 mg, about 325 mg. about 350 mg, about 400 mg, about 450 mg, about 500 mg, about 550 mg, about 600 mg, about 650 mg, about 700 mg, about 750 mg, about 800 mg, about 900 mg, or about 1000 mg.

[0149] In some embodiments, the second dosage form further includes one or more selected from the group consisting of psyllium, vitex, black cohosh, passionflower, hops, ladymantle, and evening primrose.

[0150] For example, the second dosage form may include comprises about 5 mg to about 100 mg, about 20 mg to about 50 mg, or about 30 mg to about 40 mg of the psyllium. In some embodiments, the second dosage form includes about 30 mg or about 40 mg of the psyllium.

[0151] For example, the second dosage form may include comprises about 5 mg to about 100 mg, about 5 mg to about 30 mg, or about 10 mg to about 20 mg of the vitex. In some embodiments, the second dosage form includes about 10 mg or about 20 mg of the vitex.

[0152] The second dosage form may include about 10 mg to about 100 mg, about 10 mg to about 50 mg, about 20 mg to about 40 mg, or about 30 mg to about 40 mg of the black cohosh. In some embodiments, the second dosage form includes about 10 mg, about 20 mg, about 30 mg, or about 40 mg of the black cohosh.

[0153] Tire second dosage form may include about 5 mg to about 50 mg, about 5 mg to about 20 mg, or about 5 mg to about 15 mg of the passionflower. In some embodiments, the second dosage fomr includes about 5 mg, about 10 mg, or about 15 mg of the passionflower.

[0154] Tire second dosage fomr may include about 5 mg to about 50 mg, about 5 mg to about 20 mg, or about 5 mg to about 10 mg of the hops. In some embodiments, the second dosage fomr includes about 5 mg, about 10 mg, or about 20 mg of the hops.

[0155] The second dosage form may include about 5 mg to about 50 mg, about 5 mg to about 20 mg. or about 10 mg to about 20 mg of the ladymantle. In some embodiments, the second dosage form includes about 5 mg, 10 mg, 15 mg, or 20 mg of the ladymantle.

[0156] The second dosage form may include about 10 mg to about 300 mg, about 100 mg to about 250 mg, about 125 mg to about 250 mg, or about 100 mg to about 200 mg of the evening primrose. In someembodiments, the second dosage form includes about 100 mg, about 125 mg, about 150 mg, about 200 mg, or about 250 mg of the evening primrose.Third Dosage Form

[0157] In some embodiments, a third dosage form includes about 200 mg to about 1000 mg of flaxseed, about 50 mg to 500 mg of evening primrose. The third dosage form may include about 300 mg to about 500 mg of the flaxseed and about 200 mg to 300 mg of the evening primrose. In some embodiments, the third dosage form may include about 400 mg, 300 mg, or 500 mg of the flaxseed and about 125 mg, 200 mg, or 250 mg of the evening primrose.

[0158] The third dosage form may further include about 20 mg to 80 mg of black cohosh, about 5 mg to 20 mg of passionflower, about 2 mg to about 10 mg of hops, and / or about 10 mg to about 50 mg of ladymantle.

[0159] The third dosage form may be used instead of the first dosage form, or in addition to the first and the dosage form.Kits

[0160] Tire present disclosure provides a kit for modulating menstrual cycle. The kit may include the first composition and the second composition described herein, or the first dosage form and the second dosage form described herein.

[0161] For example, the kit may include a first dosage form and a second dosage form, where the first dosage form includes about 300 mg to about 500 mg of flaxseed, and about 250 mg to about 400 mg of pumpkin seed; and the second dosage form includes about 250 mg to about 500 mg of sesame seed, and about 250 mg to about 500 mg of sunflower seed. The dosage forms may be capsules or tablets and may be contained in bottles. For example, tire first dosage forms are contained in a first bottle and the second dosage forms are contained in a second bottle and bottles may be labeled accordingly. The first dosage form and the second dosage forms are further describe herein.

[0162] In one embodiment, a kit further includes instructions for use. a label and / or instructions for use of the compounds in the treatment of the indications, including the diseases or conditions, described herein.Menstrual Cycle Modulation

[0163] The menstrual cycle is divided into two main phases: the follicular phase and the luteal phase: The follicular phase begins on the first day of menstruation and lasts until ovulation. The luteal phase begins after ovulation and lasts until the start of menstruation.

[0164] Duration of the follicular phase varies significantly among individuals and even from cycle to cycle for the same person, influenced by several factors, including hormonal balance, overall health, stress levels, and lifestyle factors. Generally, it starts on the first day of menstruation and ends with ovulation. This phase is notably the most variable part of the menstrual cycle in terms of its length. Typically, the follicular phase lasts for about 10 to 16 days. However, this can vary widely. In a standard 28-day menstrual cycle, ovulation occurs around day 14, which means that the follicular phase would last approximately two weeks (e.g. days 1-14). In longer cycles, the follicular phase may extend beyond 16 days, while in shorter cycles, it could be shorter than 10 days.

[0165] Tire follicular phase is characterized by significant hormonal activities that prepare the body for a possible pregnancy, including release of gonadotropin-releasing hormone (GnRH), follicle-stimulating hormone (FSH) and estrogen.

[0166] The luteal phase is the portion of the menstrual cycle that occurs after ovulation and before the start of menstruation. Unlike the follicular phase, which can vary greatly in length from person to person and cycle to cycle, the luteal phase is more consistent in its duration.

[0167] Typically, tire luteal phase lasts about 14 days (e.g. days 15-28), ranging from 12 to 16 days for most individuals. This phase's consistency in length is crucial for understanding the timing of the menstrual cycle and for fertility planning. The luteal phase's duration is less variable than the follicular phase, making it a more reliable measure for calculating the length of the menstrual cycle.

[0168] During the luteal phase, the corpus luteum (formed from the ovarian follicle that released the egg during ovulation) produces progesterone. Progesterone is essential for maintaining the thickened lining of the uterus (endometrium), preparing it for a potential pregnancy. If fertilization does not occur, the corpus luteum degenerates, leading to a drop in progesterone levels, which triggers the shedding of the uterine lining, resulting in menstruation and the start of a new menstrual cycle.

[0169] Several types of seeds are provided in the present disclosure for modulating or improving the hormone balance during the follicular phase and / or the luteal phase. Improved hormonal balance can lead to a more regular menstrual cycle and alleviate symptoms associated with hormonal fluctuations during the follicular phase and / or luteal phase.

[0170] The balance of hormones undergoes significant fluctuations throughout the menstrual cycle. During the follicular phase, this includes the interplay between estrogen, progesterone, follicle- stimulating hormone (FSH). luteinizing hormone (LH), and inhibin. In the follicular phase, FSH levels initially rise, peaking early before gradually declining. Estrogen levels start low and steadily increase, which in turn suppresses FSH production. As estrogen levels peak towards the end of this phase, they trigger a sharp increase in LH. Progesterone levels remain relatively low throughout most of the follicular phase, with a slight increase towards the end to help regulate the menstrual cycle and prepare the uterusfor potential implantation. Additionally, inhibin, produced by the mature dominant follicle, signals the pituitary gland to reduce FSH production, ensuring that only one egg matures per cycle.

[0171] In certain embodiments, administration of the first composition or the first dosage form provided herein increases the estrogen level during the follicular phase.

[0172] During the luteal phase, the balance of hormone shifts to the equilibrium among progesterone, estrogen, LH, FSH, and inhibin. Progesterone, produced by the corpus luteum, is the dominant hormone. Estrogen levels initially decrease post-ovulation, then rise again due to the corpus luteum's influence, aiding in further development of the uterine lining alongside progesterone. LH and FSH levels are lower in the luteal phase than in the follicular phase, with high levels of estrogen and progesterone providing negative feedback to the pituitary gland, thus suppressing LH and FSH secretion and preventing the start of a new menstrual cycle. Inhibin, also produced by the corpus luteum, helps regulate FSH (and to a lesser extent, LH) levels, supporting the hormone balance critical for the luteal phase and the onset of pregnancy.

[0173] In certain embodiments, administration of the second composition or the second dosage form provided herein increases the progesterone level during the luteal phase.

[0174] The balance of these hormones is essential for reproductive health and the regulation of the menstrual cycle. Disruptions in the levels of these hormones can lead to menstrual irregularities, fertility issues, and other health problems. Lifestyle factors, stress, and underlying health conditions can influence hormone balance.

[0175] In one aspect, provided herein is a method of improving hormone balance during the follicular phase by administering the first composition or the kit provided herein.

[0176] In one aspect, provided herein is a method of improving hormone balance during tire luteal phase by administering the second composition or the kit provided herein.

[0177] In one aspect, provided herein is a method of improving hormone balance during the menstrual cycle by administering the first and second composition, or the kit provided herein.

[0178] In one aspect, provided herein is a method of alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD), including administering the first and second composition, or the kit provided herein.

[0179] In one aspect, provided herein is use of the first and second composition, the first and second dosage forms, or the kit provided herein in the manufacture of alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).

[0180] In one aspect, provided herein is the first and second composition, the first and second dosage fomrs, or the kit provided herein for use in the alleviation or treatment of premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).

[0181] In certain embodiments, the first composition or the first dosage form is administered during the follicle phase, or for the follicle phase administration. In certain embodiments, the second composition or the second dosage form is administered during the luteal phase, or for the luteal phase administration.

[0182] In certain embodiments, the first and the second compositions or dosage forms provided herein are administered orally.

[0183] In certain embodiments, the first and the second compositions or dosage forms are administered once a day, or twice a day.

[0184] In certain embodiments, one, two, or three dosage forms are administered per day.

[0185] In certain embodiments, the first and the second compositions provided herein are administered at a daily dosage of at least about 500mg, 550mg, 600mg, 650mg, 700mg, 720 mg, 725 mg, 730 mg, 750mg, 800mg, 850mg, 900mg, 950mg. lOOOmg, HOOmg, 1200mg, 1300mg. 1400mg, 1440 mg, 1450 mg, 1460 mg, 1500mg, 1600mg 1700mg, 1800mg 1900mg. 2000mg, 2100mg, 2400mg, 2500mg. 2800mg, or 3000mg.

[0186] In certain embodiments, the first and the second compositions provided herein are administered in a daily dosage of at least 700mg, 725mg, 730mg, 1400 mg, 1450 mg or 1460 mg.

[0187] In certain embodiments wherein the patient's condition does not improve, upon the discretion of a healthcare professional the administration of the composition provided herein are administered chronically, that is, for an extended period of time, including throughout the duration of the patient’s life in order to ameliorate or otherwise control or limit the symptoms of the patient’s disease or condition. In certain embodiments, the duration of the modulation or treatment may last at least 1 month, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 12 months, at least 18 months, or at least 24 months.

[0188] In certain embodiments wherein a patient's status does improve, the dose of drug being administered is temporarily reduced or temporarily suspended for a certain length of time (z.e., a “drug holiday”). In specific embodiments, the length of the drug holiday is between 1 month and 2 years, including by way of example only, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 10 months, 12 months, 15 months, 20 months, or 24 months. The dose reduction during a drug holiday is, byway of example only, by 10%- 100%, including by way of example only 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%. 65%. 70%, 75%, 80%, 85%, 90%, 95%, and 100%.

[0189] Once improvement of the patient's conditions has occurred, a maintenance dose is administered if necessary. Subsequently, in specific embodiments, the dosage or the frequency of administration, or both, is reduced, as a function of the symptoms, to a level at which the improved disease, disorder or condition is retained. In certain embodiments, however, the patient requires intermittent treatment on a long-term basis upon any recurrence of symptoms.

[0190] It is understood that the dosage regimen to treat, prevent, or ameliorate the disease(s) for which relief is sought, is modified in accordance with a variety of factors (e.g. the disease or disorder from about which the subject suffers; the age, weight, sex, diet, and medical condition of the subject). Thus, in some instances, the dosage regimen actually employed varies and. in some embodiments, deviates from about the dosage regimens set forth herein.

[0191] In some embodiments, the daily dosage or the amount of active in the dosage form are lower or higher than the ranges indicated herein, based on a number of variables in regard to an individual treatment regime. In various embodiments, the daily and unit dosages are altered depending on a number of variables including, but not limited to, the activity of the compound used, tire disease or condition to be treated, the mode of administration, the requirements of the individual subject, the severity of the disease or condition being treated, and the judgment of the practitioner.

[0192] The compound of the present disclosure is administered to a subject at various dosing amounts per dose or per day. Daily dosage of the first composition or the second composition may be between about 500mg to 3000mg, such as from about 500mg to 295 Omg, from about 500mg to 2900mg, from about 500mg to 2500mg, from about 500mg to 2000mg, from about 500mg to 1500mg, from about 500mg to 1400mg, from about 500mg to 1300mg, from about 500mg to 1200mg, from about 500mg to 1 lOOmg, from about 500mg to lOOOmg, from about 600mg to lOOOmg, from about 700mg to lOOOmg, from about 700mg to 900mg, from about 700mg to 800mg, from about 700mg to 750mg.

[0193] In certain embodiments, the dosing amount is equivalent or at least about 500mg, 550mg, 600mg, 650mg, 700mg, 720 mg, 725 mg, 730 mg, 750mg, 800mg, 850mg, 900mg, 950mg, lOOOmg, 1 lOOmg, 1200mg, 1300mg, 1400mg, 1440 mg, 1450 mg, 1460 mg, 1500mg, 1600mg 1700mg, 1800mg 1900mg, 2000mg, 2100mg, 2400mg, 2500mg, 2800mg, or 3000mg.

[0194] In any of the aforementioned aspects are fiirther embodiments comprising single administrations of the effective amount of the composition provided herein, including fiirther embodiments in which (i) the compositions are administered once a day; (ii) the compositions provided herein is administered to the patient twice in the one day, or (iii) the compositions provided herein are administered to the patient multiple times over the span of one day.

[0195] In any of the aforementioned aspects are further embodiments comprising multiple administrations of the effective amount of the composition provided herein, including fiirther embodiments in which (i) the compositions provided herein is administered continuously or intermittently as in a single dose; (ii) the time between multiple administrations is every 6 hours; (iii) the compositions provided herein is administered to the patient every 8 hours; (iv) the compositions provided herein is administered to the patient every 12 hours; (v) the compositions provided herein is administered to the patient every’ 24 hours. In fiirther or alternative embodiments, the method comprises a drug holiday,wherein the administration of the compositions provided herein are temporarily suspended or the dose of the compositions provided herein being administered is temporarily reduced; at the end of the drug holiday, dosing of the compositions provided herein are resumed. In one embodiment, the length of the drug holiday varies from about 1 month to 2 years.

[0196] In certain instances, it is appropriate to administer compositions provided herein described herein, in combination with one or more other therapeutic agents.

[0197] In one embodiment, the benefit experienced by a patient is increased by administering one of the compositions provided herein described herein with another agent (which also includes a therapeutic regimen) that also has therapeutic benefit.

[0198] In one specific embodiment, a composition provided herein described herein is co -administered with a second therapeutic agent, or an additional therapy, wherein the composition provided herein and the second therapeutic agent or additional therapy modulate different aspects of the disease, disorder or condition being treated, thereby providing a greater overall benefit than administration of either therapeutic agent alone. In certain embodiments, the second therapeutic agent includes, but are not limited to hormonal contraceptives (birth control pills), antidepressants (selective serotonin reuptake inhibitors (SSRIs)), nonsteroidal anti-inflammatory drugs (NSAIDs), diuretics, gonadotropin-releasing hormone (GnRH) agonists, or dietary supplements, such as calcium, magnesium, vitamin B6. and vitamin E. In certain embodiments, the additional therapy includes lifestyle modifications and cognitive behavioral therapy (CBT).

[0199] In any case, regardless of the disease, disorder or condition being treated, the overall benefit experienced by the patient is to be simply additive of the two therapeutic agents or the patient experiences a synergistic benefit.

[0200] In certain embodiments, different therapeutically-effective dosages of the compositions provided herein will be utilized in fonnulating pharmacal composition and / or in treatment regimens when the composition provided herein are administered in combination with one or more additional agent, such as an additional therapeutically effective drug, an adjuvant or the like. Therapeutically-effective dosages of drugs and other agents for use in combination treatment regimens is optionally determined by means similar to those set forth hereinabove for the actives themselves. In some embodiments, a combination treatment regimen encompasses treatment regimens in which administration of a composition provided herein, is initiated prior to, during, or after treatment with a second agent described herein, and continues until any time during treatment with the second agent or after termination of treatment with the second agent. It also includes treatments in which a composition provided herein and the second agent being used in combination are administered simultaneously or at different times and / or at decreasing or increasingintervals during the treatment period. Combination treatment further includes periodic treatments that start and stop at various times to assist with the clinical management of the patient.

[0201] For combination therapies described herein, dosages of the co-administered composition provided herein vary depending on the type of co-drug employed, on the specific drug employed, on the disease or condition being treated and so forth. In additional embodiments, when co-administered with one or more other therapeutic agents, the composition provided herein provided herein is administered either simultaneously with the one or more other therapeutic agents, or sequentially.

[0202] In combination therapies, the multiple therapeutic agents (one of which is the composition provided herein described herein) are administered in any order or even simultaneously. If administration is simultaneous, the multiple therapeutic agents are, by way of example only, provided in a single, unified form, or in multiple forms (e.g., as a single pill or as two separate pills).

[0203] The composition described herein, as well as combination therapies, are administered before, during or after the occurrence of a disease or condition, such as the imbalanced hormone of the menstrual cycle, PMS or PMDD, and the timing of administering the compositions varies. Thus, in one embodiment, the compositions provided herein described herein is used as a prophylactic and are administered continuously to subjects with a propensity to develop conditions or diseases in order to prevent the occurrence of the disease or condition. In another embodiment, the composition provided herein is administered to a subject during or as soon as possible after the onset of the symptoms. In specific embodiments, a composition provided herein described herein is administered as soon as is practicable after the onset of a disease or condition is detected or suspected, and for a length of time necessary for the treatment of the disease. In some embodiments, the length required for treatment varies, and the treatment length is adjusted to suit the specific needs of each subject. For example, in specific embodiments, a composition is administered for at least about 1 month to about 5 years.EXAMPLESExample 1. Seed Cycling Compositions

[0204] The study are designed with two seed capsules for the management of the PMS and PMDD. The first capsule (Zest) is administered during the follicle phase (e.g. day 1-14 in a standard 28-day menstrual cycle), and the second capsule (Zen) is administered during the follicle phase (e.g. day 15-28 in a standard 28-day menstrual cycle), with 2 capsules daily.

[0205] Follicular Phase Seeds: Flaxseeds and Pumpkin Seeds are rich in lignans, which have phytoestrogenic properties that can support balanced estrogen levels during the follicular phase. Pumpkin seeds are high in zinc, which can support progesterone production and can help prepare the body for ovulation.

[0206] Luteal Phase Seeds: Sesame Seeds and Sunflower Seeds are rich in lignans and omega-6 fatty acids, which can help support progesterone production during the luteal phase. Sunflower seeds are high in vitamin E, which can help support relief from PMS symptoms like breast pain and mood swings.

[0207] Tire various compositions are listed as in Table 1, coated with "00" Veggie Capsule.Table 1. Components of the seed cyclingExample 2. Administration of Seed Cycling Compositions to Human Subjects

[0208] Female subjects are recruited for the study. Tire subjects were required to be between the ages of 20 and 50 and to have active menstrual cycle (i.e. before menopause). Subjects are randomly assigned to receive either no therapy or placebo (“control”) or one of Combinations A-P from Example 1.

[0209] Before treatment, the subjects are assessed for their menstrual cycle, and follicular and luteal phases for each of the subjects are configured. Each subject are also monitored for one or more cycles for serum hormone level and any symptoms of PMS or PMDD.

[0210] Except for the control subjects, subjects are administered the first dosage form once daily during the follicular phase and the second dosage form once daily during the luteal phase. For each subject, clinical parameters, including symptoms of PMS or PMDD. and serum hormone level are assessed one day before (as a baseline) the initial dose and throughout menstmal cycle.

[0211] Results are compared between the control subjects and the subjects who were administered with dosage forms of Example 1.* * *

[0212] The present disclosure is not to be limited in scope by the specific embodiments described which are intended as single illustrations of individual aspects of the disclosure, and any compositions or methods which are functionally equivalent are within the scope of this disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made in the methods and compositions of the present disclosure without departing from about the spirit or scope of the disclosure. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.

[0213] All publications and patent applications mentioned in this specification arc herein incorporated byreference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Claims

CLAIMSWhat is claimed is:

1. A dosage form comprising: about 30% w / w to about 70% w / w of flaxseed, and about 30% w / w to about 70% w / w of pumpkin seed.

2. The dosage form of claim 1, further comprising one or more selected from the group consisting of:(a) about 1.0% w / w to about 5% w / w of a vitex,(b) about 2% w / w to about 7% w / w of a black cohosh,(c) about 0.5% w / w to about 2% w / w of a passionflower,(d) about 0.5% w / w to about 2% w / w of a hops.(e) about 0.5% w / w to about 3.5% w / w of a ladymantle, and(f) about 10% w / w to about 40% w / w of an evening primrose.

3. The dosage form of claim 1 or 2, wherein the dosage form comprises about 35% w / w to about 60% w / w of the flaxseed.

4. Tire dosage fonn of any one of claims 1-3, wherein the flaxseed is concentrated at least 2 times with one or more nutrients selected from the group consisting of alpha-linolenic acid (ALA), lignans, dietary fiber, plant protein, vitamins and minerals, and phytochemicals.

5. Tire dosage form of any one of claims 1-5, wherein the dosage form comprises about 32% w / w to about 55% w / w of the pumpkin seed.

6. The dosage form of any one of claims 1-6, wherein the pumpkin seed is concentrated with one or more nutrients selected from the group consisting of lignan, zinc, omega-3 fatty acids, magnesium, phytoestrogens and try tophan.

7. The dosage form of claim 2, wherein the dosage form comprises about 1.2% w / w to about 3.5% w / w of the vitex.

8. The dosage fomi of any one of claims 1-7, wherein the dosage fonn is a capsule or a tablet.

9. Tire dosage form of any one of claims 1-8, wherein the dosage form comprises about 300 mg to about 500 mg of the flaxseed and about 250 mg to about 400 mg of the pumpkin seed.

10. The dosage form of any one of claims 1-8, wherein the dosage form comprises about 300 mg to about 400 mg of the flaxseed and about 250 mg to about 400 mg of the pumpkin seed.

11. The dosage form of any one of claims 1-8, wherein the dosage form comprises about 600 mg to about 1000 mg of the flaxseed and about 500 mg to about 800 mg of the pumpkin seed.

12. Tire dosage form of any one of claims 1-8, wherein the dosage form comprises about 600 mg to about 800 mg of the flaxseed and about 500 mg to about 800 mg of the pumpkin seed.

13. A dosage form comprising: about 30% w / w to about 70% w / w of sesame seed, and about 30% w / w to about 70% w / w of sunflower seed.

14. The dosage form of claim 13, further comprising one or more selected from the group consisting of:(a) about 4% w / w-7% w / w psyllium,(b) about 1% w / w-5% w / w vitex,(c) about 2% w / w-7% w / w black cohosh,(d) about 0.5% w / w-2% w / w passionflower,(e) about 0.5% w / w-2% w / w hops,(f) about 0.5% w / w-3.5% w / w ladymantle, and / or(g) about 10% w / w-25% w / w evening primrose.

15. The dosage form of claim 13 or 14, wherein the dosage form comprises about 35% w / w to about 60% w / w of the sesame seed.

16. Tire dosage form of claim 15, wherein the sesame seed is concentrated with one or more nutrients selected from the group consisting of fatty acids, vitamin B6, magnesium and calcium, lignans and phytoestrogen.

17. Tire dosage form of claim 16, wherein the dosage form comprises about 32% w / w to about 55% w / w of the sunflower seed.

18. The dosage form of any one of claims 13-17, wherein the sunflower seed is concentrated one or more nutrients selected from the group consisting of lignans, vitamin E, selenium, essential fatty acids, and magnesium.

19. The dosage form of any one of claims 22-32, wherein the dosage form comprises about 1.2% w / w to about 3.5% w / w of the vitex.

20. The dosage form of any one of claims 13-19, wherein the dosage form is a capsule or tablet.

21. Tire dosage form of any one of claims 13-20, wherein the dosage form comprises about 250 mg to about 500 mg of the sesame seed and about 250 mg to about 500 mg of the sesame seed.

22. Tire dosage form of any one of claims 13-20, wherein the dosage form comprises about 250 mg to about 400 mg of the sesame seed and about 250 mg to about 400 mg of the sunflower seed.

23. The dosage form of any one of claims 13-20, wherein the dosage form comprises about 500 mg to about 1000 mg of the sesame seed and about 500 mg to about 1000 mg of the sesame seed.

24. Tire dosage form of any one of claims 13-20, wherein the dosage form comprises about 500 mg to about 800 mg of the sesame seed and about 500 mg to about 800 mg of the sunflower seed.

25. A kit comprising the dosage form of claims 1-12 and the dosage form of claims 13-24.

26. A kit comprising a first dosage form and a second dosage form. wherein the first dosage fonn comprises about 300 mg to about 500 mg of flaxseed, and about 250 mg to about 400 mg of pumpkin seed; and wherein the second dosage fomi comprises about 250 mg to about 500 mg of sesame seed, and about 250 mg to about 500 mg of sunflower seed.

27. The kit of claim 26, wherein the first dosage form and the second dosage form are capsules or tablets.

28. The kit of claim 26 or 27, wherein the first dosage fonn comprises about 300 mg to about 400 mg of the flaxseed.

29. Tire kit of any one of claims 26-28, wherein the first dosage form comprises about 250 mg to about 350 mg of the pumpkin seed.

30. Tire kit of any one of claims 26-29, wherein the second dosage form comprises about 250 mg to about 400 mg of the sesame seed.

31. The kit of any one of claims 26-30, wherein the second dosage form comprises about 250 mg to about 400 mg of the sunflower seed.

32. The kit of any one of claims 26-31, wherein the first dosage fonn further comprises one or more selected from the group consisting of vitex. black cohosh, passionflower, hops, ladymantle, and evening primrose.

33. The kit of claim 32, wherein the first dosage fonn comprises about 10 mg to about 20 mg of the vitex.

34. Tire kit of claim 32 or 33, wherein the first dosage form comprises about 20 mg to about 40 mg of the black cohosh.

35. The kit of any one of claims 32-34, wherein the first dosage form comprises about 5 mg to about 15 mg of the passionflower.

36. The kit of any one of claims 32-35, wherein the first dosage fonn comprises about 5 mg to about 10 mg of the hops.

37. Tire kit of any one of claims 32-36, wherein the first dosage form comprises about 10 mg to about 20 mg of the ladymantle.

38. Tire kit of any one of claims 32-37, wherein the first dosage form comprises about 100 mg to 250 mg of the evening primrose.

39. The kit of any one of claims 26-38, wherein the second dosage form comprises about 250 mg to about 400 mg of the sesame seed.

40. The kit of any one of claims 26-39, wherein the second dosage form comprises about 250 mg to about 400 mg of the sunflower seed.

41. Tire kit of any one of claims 26-40, wherein the second dosage form further comprises one or more selected from the group consisting of psyllium, vitex, black cohosh, passionflower, hops, ladymantle, and evening primrose.

42. Tire kit of claim 41, wherein the second dosage form comprises about 30 mg to about 40 mg of the psyllium.

43. The kit of claim 41 or 42, wherein the second dosage form comprises about 10 mg to about 20 mg of the vitex.

44. The kit of any one of claims 41-43, wherein the second dosage form comprises about 20 mg to about 40 mg of the black cohosh.

45. Tire kit of any one of claims 41-44, wherein the second dosage form comprises about 5 mg to about 15 mg of the passionflower.

46. Tire kit of any one of claims 41-45, wherein the second dosage form comprises about 5 mg to about 10 mg of the hops.

47. The kit of any one of claims 41-46, wherein the second dosage form comprises about 10 mg to about 20 mg of the ladymantle.

48. Tire kit of any one of claims 41-47, wherein the second dosage form comprises about 100 mg to 250 mg of the evening primrose.

49. A method of improving hormone balance during follicular phase of menstrual cycle in a subject in need thereof, comprising orally administering the dosage form of any one of claims 1-12 to the subject.

50. A method of improving hormone balance during luteal phase of menstrual cycle in a subject in need thereof, comprising orally administering the dosage form of any one of claims 13-24 to the subject.

51. A method of modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) in a subject in need thereof, comprising orally administering the dosage form of any one of claims 1-12 during follicular phase of menstrual cycle and administering the dosage fomr of any one of claims 13-24 during luteal phase of menstrual cycle.

52. A method of modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD), comprising using the kit of any one of claims 25-48 to the subject.

53. A method of modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD), comprising:administering orally a first dosage form to the subject during follicular phase of menstrual cycle, the first dosage form comprising: about 300 mg to about 500 mg of flaxseed; and about 250 mg to 400 mg of pumpkin seed, and administering orally a second dosage form to the subject during luteal phase of menstrual cycle, the second dosage form comprising: about 250 mg to about 500 mg of sesame seed, and about 250 mg to about 500 mg of sunflower seed.

54. The method of claim 53, wherein the follicular phase is days 1-14 of the menstrual cycle, and the luteal phase is days 15-28 of tire menstrual cycle.

55. The method of claim 53 or 54, wherein the first dosage form and the second dosage fonn are administered once daily.

56. Tire method of any one of claims 53-55, wherein the first dosage fomr and the second dosage fonn are capsules or tablets.

57. Tire method of any one of claims 53-56, wherein the first dosage form comprises about 300 mg to about 400 mg of the flaxseed.

58. The method of any one of claims 53-57, wherein the first dosage form comprises about 250 mg to about 350 mg of the pumpkin seed.

59. The method of any one of claims 53-58, wherein the second dosage fomr comprises about 250 mg to about 400 mg of the sesame seed.

60. Tire method of any one of claims 53-59, wherein the second dosage fonn comprises about 250 mg to about 400 mg of the sunflower seed.

61. The method of any one of claims 53-60, wherein the first dosage form further comprises one or more selected from the group consisting of vitex, black cohosh, passionflower, hops, ladymantle, and evening primrose.

62. The method of claim 61, wherein the first dosage fomr comprises about 10 mg to about 20 mg of the vitex.

63. The method of claim 61 or 62, wherein the first dosage form comprises about 20 mg to about 40 mg of the black cohosh.

64. The method of any one of claims 61-63, wherein the first dosage form comprises about 5 mg to about 15 mg of the passionflower.

65. Tire method of any one of claims 61-64, wherein the first dosage form comprises about 5 mg to about 10 mg of the hops.

66. Tire method of any one of claims 61-65, wherein the first dosage form comprises about 10 mg to about 20 mg of the ladymantle.

67. The method of any one of claims 61-66, wherein the first dosage form comprises about 100 mg to 250 mg of the evening primrose.

68. Tire method of any one of claims 53-67, wherein the second dosage form comprises about 250 mg to about 400 mg of the sesame seed.

69. Tire method of any one of claims 53-68, wherein the second dosage form comprises about 250 mg to about 400 mg of the sunflower seed.

70. The method of any one of claims 53-69, wherein the second dosage form further comprises one or more selected from the group consisting of psyllium, vitex, black cohosh, passionflower, hops, ladymantle, and evening primrose.

71. The method of claim 70, wherein the second dosage form comprises about 30 mg to about 40 mg of the psyllium.

72. The method of claim 70 or 71, wherein the second dosage form comprises about 10 mg to about 20 mg of the vitex.

73. Tire method of any one of claims 70-72, wherein the second dosage form comprises about 20 mg to about 40 mg of the black cohosh.

74. The method of any one of claims 70-73, wherein the second dosage form comprises about 5 mg to about 15 mg of the passionflower.

75. The method of any one of claims 70-74, wherein the second dosage form comprises about 5 mg to about 10 mg of the hops.

76. The method of any one of claims 70-75, wherein the second dosage form comprises about 10 mg to about 20 mg of the ladymantle.

77. Tire method of any one of claims 70-76, wherein the second dosage form comprises about 100 mg to 250 mg of the evening primrose.

78. Use of the dosage form of any one of claims 1-12 for improving hormone balance during follicular phase of menstrual cycle in a subject in need thereof.

79. Use of the dosage form of any one of claims 13-24 for improving honnone balance during luteal phase of menstrual cycle in a subject in need thereof.

80. Use of the kit of any one of claims 25-48 for modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).

81. Tire kit of any one of claims 25-48, for modulating irregular menstrual cycle, or alleviating or treating premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).

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