Method for treating symptoms of hormone imbalance

Abstract

In a new supplemental combination and method of treatment, the herbs Vitex agnus-castus (chasteberry), green tea, and arginine treat premenstrual syndrome, premenstrual tension, as an alternative to conventional women's hormone replacement therapy, and to offset the problems related to sub-optimal hormone balance or decline resulting from age, genetics, stress, or environmental influences. Furthermore, the combination may be enhanced with a phytoestrogen and/or a progesterone-receptor enhancing agent.

Claims

1. A pharmaceutical composition consisting of an ingestible dietary supplement for treating symptoms of hormone imbalance, hormonal decline, premenstrual tension, or premenstrual syndrome in females, the ingestible dietary supplement consisting of in combination components in effective amounts of Vitex agnus-castus (chasteberry), antioxidants, L-arginine, a phytoestrogen, a progesterone-receptor enhancer Phaleria macrocarpa, folic acid, vitamin B6, vitamin B12, iron, zinc, and magnesium; wherein the antioxidants are selected from the group consisting of green tea, vitamin E, selenium, and combinations thereof, the ingestible dietary supplement of the pharmaceutical composition taken as an alternative to conventional hormone replacement therapy to offset problems of sub-optimal hormone balance or decline resulting from age, genetics, stress, or environmental influences, wherein the components are present in the proportion in parts by weight of about 2 to 20% Vitex agnus-castus (chasteberry), about 5 to 50% antioxidants selected from the group consisting of green tea, vitamin E, selenium, and combinations thereof, about 10 to 80% L-arginine, about 0.001 to 1% folic acid, about 0.001 to 1% vitamin B6 and vitamin B12, about 0.1 to 10% iron, about 0.1 to 10% zinc, and about 5 to 50% magnesium.

2. The pharmaceutical composition of claim 1, wherein the phytoestrogen is selected from the group consisting of soy, black cohosh, and wild yam extract.

3. A method for treating symptoms of premenstrual syndrome or premenstrual tension, the method comprising ingesting the pharmaceutical composition of claim 1.

4. A method for treating symptoms of premenstrual syndrome or premenstrual tension, the method comprising ingesting the pharmaceutical composition of claim 2.

Description

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(1) The invention provides combinations of beneficial bioeffecting compounds for maintaining and restoring hormone balance in post-menopausal women, and reducing premenstrual syndrome and premenstrual tension in women. The invention provides a scientifically validated herbal/nutritional blend for women to improve and treat symptoms of premenstrual syndrome and premenstrual tension by helping to regulate the menstrual cycle and correct hormone imbalance (corpus luteum insufficiency). The combination of amino acids, herbs, vitamins and minerals improves overall health and helps with many of the deficiencies that accompany symptoms of premenstrual syndrome and premenstrual tension.

(2) The herb, Vitex agnus-castus (chasteberry), enhances hormone balance by increasing progesterone release and, therefore, ovulation frequency. The antioxidants, green tea, vitamin E, and selenium, improve overall reproductive health. L-arginine, an amino acid, stimulates the reproductive, endocrine, and other hormone-producing organs by improving circulation. Folic acid, vitamins B6 and B12, iron, zinc and magnesium help promote womens' overall health necessary for optimal hormone balance.

(3) The invention provides combinations of beneficial bioeffecting compounds for symptoms of premenstrual syndrome and premenstrual tension in women. Vitamins C and E, coenzyme Q10 and selenium are all potent antioxidants that help create a healthier physiology that promotes a more optimal hormone balance. Ferulic acid, an antioxidant found in Dong quai, zinc and B vitamins (B6, B12 and folate) are nutrients also beneficial in this way.

(4) A method for treating symptoms of premenstrual syndrome or premenstrual tension is disclosed. The method comprises ingesting an ingestible dietary supplement having ingredients of vitex agnus and arginine, and taking the ingestible dietary supplement as an alternative to conventional hormone replacement therapy and offsetting problems of sub-optimal hormone balance or decline resulting from age, genetics, stress, or environmental influences.

(5) A method for treating symptoms of premenstrual syndrome or premenstrual tension is disclosed. The method comprises ingesting an ingestible dietary supplement having ingredients of vitex agnus and green tea, and taking the ingestible dietary supplement as an alternative to conventional hormone replacement therapy and offsetting problems of sub-optimal hormone balance or decline resulting from age, genetics, stress, or environmental influences.

(6) The present invention is also drawn to counteract “endocrine disrupters,” especially external agents and environmental contaminants that have an estrogenic effect called “xenoestrogens.”

(7) In another embodiment, a “phytoestrogen” is added to the formulation. This might include, but is not limited to, soy, black cohosh, or wild yam extract. A phytoestrogen competitively binds estrogen receptors in the body to prevent stronger estrogens like xenoestrogens from having a more biologically potent estrogenic effect. In effect, this better improves the progesterone-enhancing ability of the base formula to overcome estrogen dominance that can cause the problematic symptoms listed in this patent application.

(8) In a further embodiment, a “progesterone-receptor” enhancing ingredient is added to the formulation. This improves the progesterone to estrogen balance in women's body to overcome estrogen dominance. Such an ingredient is phaleria macrocarpa, a botanical ingredient reported to increase progesterone receptors.

(9) The invention provides synergistic action of the combinations.

(10) The two dietary supplements in female formulas are useful for women. Preferably, the distinct combinations are taken by females between the ages is between 21 and older, preferably 35+ years of age. The distinct combinations are useful for women who have sought relief from symptoms associated with premenstrual syndrome and premenstrual tension without success. Preferably, patients take 2-4 capsules per day of the distinct formulas for three months.

(11) Table 1 shows the preferred ranges of the combinations considered in percent by weight.

(12) TABLE-US-00001 TABLE 3 Hormone Balance Formula: mg/dose % DV % by wt. mg/3 caps mg/cap L-arginine base 800 47.92% 800.00 266.67 98-99% purity Magnesium (oxide)-60% 400 100 23.96% 666.67 222.22 Green tea- 200 11.98% 220.00 73.33 50% polyphenols Iron (gluconate)-11% 18 100  1.08% 163.64 54.55 Vitamin E-alpha 150 500  8.98% 140.00 46.67 tocopherol-1.185 mg/iu Zinc (gluconate)-13% 15 100  0.90% 115.38 38.46 Vitex agnus-castus 0.5% 80  4.79% 40.00 13.33 special order from Germany Selenium TCP-0.2% 0.07 100  0.00% 35.00 11.67 Vitamin B6-82% 6.0 300  0.36% 7.20 2.40 Vitamin B12 (1%) 0.012 200  0.00% 1.44 0.48 Folic acid 0.4 100  0.02% 0.48 0.16 Rice flour* 284.70 94.90 Mg stearate* 78.00 26.00 Silica* 0.00 0.00 1669.48 100.00%  2552.51 850.84

(13) Acceptable ranges or womens' formulations are shown in Tables 2 and 3.

(14) TABLE-US-00002 TABLE 2 Components Minimum % Maximum % Vitex (chasteberry) 2 10 L-arginine 40 60 Green tea 5 20 Vitamin E 5 20 Selenium 0.01 1 Vitamins B6, B12 0.01 1 Folic acid 0.01 1 Iron 0.1 5 Magnesium 10 40 Zinc 0.001 1

(15) TABLE-US-00003 TABLE 3 Components Minimum % Maximum % Vitex (chasteberry) 1 20 L-arginine 20 70 Green tea 0 30 Vitamin E 0.01 30 Selenium 0 2 Vitamins B6, B12 0 2 Folic acid 0 2 Iron 0 7 Magnesium 0 50 Zinc 0 10

(16) Examples of useful formulation in percent by weight are shown in Table 4.

(17) TABLE-US-00004 TABLE 4 Components Wt % Vitex (chasteberry) 5 L-arginine 50 Green tea 11 Vitamin E 11 Selenium 0.1 Vitamins B6, B12 0.38 Folic acid 0.02 Iron 1 Magnesium 20 Zinc 1

(18) While the invention has been described with reference to specific embodiments, modifications and variations of the invention may be constructed without departing from the scope of the invention.