FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION (See section 10, rule 13)
HERBAL FORMULATION FOR RELIEVING FEMALE HORMONAL IMBALANCE
Inmart Commerce Private Limited
An Indian Private Limited Company
of 4 th floor, B-2/405 DSK Madhuban, Andheri Kurla Road, Saki Naka, Andheri East, Mumbai 400 072, INDIA
The following specification particularly describes and ascertains the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[0001] The present invention relates to the field of herbal formulation. Particularly, the invention relates to a herbal formulation and process of preparation thereof, which is effective in relieving female hormonal imbalance. More particularly, the invention relates to the herbal formulation to help in maintaining female health by balancing the hormones resulting in reproductive wellness.
BACKGROUND OF INVENTION
[0002] Fluctuation in hormone levels or mainly known as hormonal imbalance happens when the hormones shift from normal level. Hormonal imbalance in female causes negative impact on weight, mood, sexual desire and fertility. Often it is caused by chronic stress, poor glycaemia control, being overweight, poor nutrition and ageing. Estrogen and Progesterone are two main female hormones.
[0003] Estrogen helps to regulate parts of the brain that prepare body for sexual and reproductive development. Estrogen stimulates maturation of the ovaries, vagina, uterus and development of breast. Estrogen also helps to preserve bone density and starts of a woman's menstrual cycle. Progesterone plays an important role in regulating the condition of the endometrium of the uterus. Progesterone prepares the uterine lining to receive and nourish a fertilized egg. Progesterone helps to maintain

pregnancy and encourages growth of milk gland in the breast. Low progesterone level causes mood swings and irregular cycle.
[0004] There are few medicines available for balancing the female hormones but there are side effects leading to more critical diseases.
[0005] U. S. Patent Publication No. US20070122494A1 discloses a pharmaceutical or medicinal preparation comprising a mixture of herbs including Glycine max, Asparagus racemosa, Boerhavia diffusa, Withania somnifera, Saraca indica, and Coleus forskohlii, or a mixture of the active ingredients that have been extracted from those herbs. The herbal formulations of the present invention are effective for the treatment of hormone dependent conditions and circulatory conditions in the human body, and to stimulate the immune system.
[0006] U.S. Patent publication No. US6242012B1 discloses herbal composition which can be used to alleviate the symptoms associated with hormonal imbalance in women contains supercritical extracts of ginger, rosemary and evening primrose oil, and either regular or supercritical (preferably regular) extracts of black cohosh, dong quai, schizandra berry, chaste tree berry and rosemary. The herbal composition can be administered orally, topically or parenterally. In addition to promoting hormonal balance, the herbal composition also promotes normal bone growth by inhibiting the 5-lipoxygenase enzyme and sustains warmth and normal fluids for healthy sexual

functioning. Furthermore, the herbal composition contains organic anti-aging constituents that inactivate free radicals, thereby providing antioxidant activity.
[0007] U.S. Patent publication No. US20200129573A1 teaches about a new kind of medicinal value or health care function of Eurycoma longifolia extracts, particularly in the treatment or alleviation symptoms and/or conditions associated to hormonal imbalance in females, including menopause and its related symptoms. In one aspect, the present invention discloses the use of a composition comprising a therapeutically effective amount of Eurycoma longifolia extract in the manufacture of a medicament for the alleviation of symptoms and/or conditions associated to hormonal imbalance in females, including menopause and its related symptoms. The alleviation of the symptoms and/or conditions according to the present invention is characterised by inducing a change in the hormonal contents of estrogen, progesterone, follicle stimulating hormone (FSH) and luteinizing hormone (LH). Also disclosed is the use of a pharmaceutical composition comprising the therapeutically effective amount of Eurycoma longifolia extract.
[0008] Several chemical and herbal formulations have been tested for their action in relieving female hormonal balance, but they have either been not providing adequate relief or have undesirable side effects. Many patent applications and granted patent teaches use of the herbal compositions for relieving female hormonal balance.

[0009] Additionally, in spite of the above, the prior art generally does not reveal a herbal formulation which has the desired combination of safety, effectiveness and low cost which is needed for treating a large number of patients who have very different medical conditions and socio-economic backgrounds.
[0010] Accordingly, there is a continuous search in the art for a medicine or herbal formulation that is safe, useful and inexpensive for relieving female hormonal balance. Surprisingly, the present invention has shown that the combination of the specific ingredients provides a synergistic effect in alleviating the symptoms associated with hormonal imbalance in women. The inventors with careful experimentation have prepared a synergistic herbal composition for relieving female hormonal balance.
SUMMARY OF INVENTION
[0011] The present invention discloses a herbal formulation for relieving female hormonal imbalance. The formulation comprises of Shatavari (Asparagus racemosus), Ashoka (Saraca asoka), Turmeric (Curcuma longa), Manjishtha (Rubia cordifolia), Bilva (Aegle marmelos), Jharberi (Ziziphus nummularia), Lodhra (Symplocos racemosa), Nagkesar (Mesua ferrea), Aparajita (Clitoria ternatea), Jeera (Cuminum cyminum), Liquorice (Glycyrrhiza glabra), Suhaga (Borax), Jatamansi

(Nardostachys jatamansi) and Musbbar (Alva). Further, the herbal formulation helps in dysmenorrhoea (pain and cramping during periods), amenorrhea, leucorrhoea, premenstrual symptoms, pelvic pain and weakness, menorrhagia (Excessive bleeding and pain), perimenopausal discomfort, low fertility and Polycystic Ovary Syndrome (PCOS).
[0012] In one aspect of the invention discloses the process of preparation of the herbal formulation. The raw ingredients Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar in original dry herbal form are procured, got together and mixed (in respective ratios) for further process of grinding through pulverization. Further, the mixture is grinded through pulveriser wherein the mixed formulation (i.e the dry herbal raw ingredients mixed together in respective ratios) is then put through the pulveriser for grinding. The griding process leads to a loss of ~10% of the weighted formulation in this step. Furthermore, the grinded mixture is processed by sifting, wherein the matter is passed through the sift for gaining even more fine powder, where there might be a loss of ~1% of the net weight and it removes any granules or larger particles. Moreover, post sifting the entire mixture is even further mixed, to ensure thorough mixing of the ingredients and to gain uniformity. [0013] In another aspect of the invention discloses the process of preparation of capsule of the herbal formulation. Wherein the Ingredients in the form of dry herbal

extracts are procured. The dry extract is made via a standard extraction process using a “Clavenger Apparatus” are process; then a quath (“boiled syrup formulation”) is formed; the quath is dried and converted to dry extract which is a concentrated dry fine powder of the herb. Further, the dry extracts of the ingredients are then mixed as per respective ratios, the mixed formulated ingredients are then undergo sifting to remove larger particles and achieve more fineness, which also removes any contaminants. The mixture is then further mixed to achieve uniformity and then excipients are added in respective ratios (for better adsorption within the body). Moreover, the final mixture is then filled in the capsules through standard encapsulation process using capsules of either gelatin or veg. (rice) based. [0014] In general, in another aspect of the invention, the herbal formulation helps in diseases like dysmenorrhoea (pain and cramping during periods), amenorrhea, leucorrhoea, premenstrual symptoms, pelvic pain and weakness, menorrhagia (Excessive bleeding and pain), perimenopausal discomfort, low fertility and PCOS. [0015] In another aspect of the present invention, the prescribed dosage of 1-2 capsules twice daily must be taken for 3 months for visible effects. [0016] In yet another aspect of the present invention, the herbal formulation can be administered orally in the form of a tablet, capsule, powder or liquid or in the form of nutritional supplement.

DETAILED DESCRIPTION OF INVENTION
[0017] The following description is full and informative description of the best method presently contemplated for carrying out the present invention which is known to the inventors at the time of filing the patent application. Of course, many modifications and adaptations will be apparent to those skilled in the relevant arts in view of the following description in view of the accompanying drawings and the appended claims. While the system and method described herein are provided with a certain degree of specificity, the present technique may be implemented with either greater or lesser specificity, depending on the needs of the user. Further, some of the features of the present technique may be used to advantage without the corresponding use of other features described in the following paragraphs. As such, the present description should be considered as merely illustrative of the principles of the present technique and not in limitation thereof, since the present technique is defined solely by the claims.
[0018] The present invention relates to the field of herbal formulation. Particularly, the invention relates to a herbal formulation and process of preparation thereof, which is effective in relieving female hormonal imbalance. More particularly, the invention relates to the herbal formulation to help in maintaining female health by balancing the hormones resulting in reproductive wellness.

[0019] In one embodiment of the invention discloses a herbal formulation for regulating respiratory wellness. The formulation comprises of Shatavari (Asparagus racemosus), Ashoka (Saraca asoka), Turmeric (Curcuma longa), Manjishtha (Rubia cordifolia), Bilva (Aegle marmelos), Jharberi (Ziziphus nummularia), Lodhra (Symplocos racemosa), Nagkesar (Mesua ferrea), Aparajita (Clitoria ternatea), Jeera (Cuminum cyminum), Liquorice (Glycyrrhiza glabra), Suhaga (Borax), Jatamansi (Nardostachys jatamansi) and Musbbar (Alva). Further, the herbal formulation helps promote immunity of the respiratory system and help in curing diseases like dysmenorrhoea (pain and cramping during periods), amenorrhea, leucorrhoea, premenstrual symptoms, pelvic pain and weakness, menorrhagia (Excessive bleeding and pain), perimenopausal discomfort, low fertility and PCOS.
[0020] In another embodiment of the invention root of shatavari, stem bark of ashoka, rhizome of turmeric, dry stem of manjishtha, fruit of bilva, root of jharberi, stem bark of lodhra, stamen of nagkesar, flower of aparajita, seed of jeera, stem of liquorice and rhizome of jatamansi are used to prepare the herbal formulation.
[0021] In still another embodiment of the invention the ingredients have many medicinal properties individually. Shatavari (Asparagus racemosus) is useful in treating dyspepsia, constipation, stomach spasms, stomach ulcers, fluid retention, pain, anxiety, cancer, diarrhea, bronchitis, tuberculosis, dementia, diabetes,

aphrodisiac, uterine bleeding. Further, Ashoka (Saraca asoka) is useful in relieving thirst, burning sensation, worm infestation, emaciation, poisoning, bleeding disorders, cardiac disorders, tiredness, abdominal tumor, bloating, ascites. Act as a coolant, absorbent, natural detoxifier. Furthermore, Turmeric (Curcuma longa) is useful in curing disorders like relieves pain and inflammation, such as osteoarthritis, hay fever, depression, high cholesterol, itching, heartburn, thinking and memory skills, inflammatory bowel disease, stress. Manjishtha (Rubia cordifolia) helps in preventing and dissolving kidney stones, as well as and for treating general menstrual disorders, and urinary tract disorders, blood disorders, bruises, jaundice, paralysis, spleen disorders and sciatica.
[0022] In still another embodiment of the invention, Bilva (Aegle marmelos) is used for treating asthma, constipation, depression, diabetes, diarrhea, memory, snakebite, stomach ache, blood purification. However, Jharberi (Ziziphus nummularia) is used as anthelmitic, antitumor, antibacterial, antifertility, abortifacient, anti diarrheal, anti inflammatory, anti congestion, used to treat diabetes, fatigue, hysteria, anxiety, insomnia, seizures, fever, obesity, cancer, inflammation, asthma and other lung and eye disorders. Further, Lodhra (Symplocos racemosa) is used for treating Menorrhagia, leucorrhoea, body detoxification, eye diseases, for glowing skin, leprosy, inflammation. Furthermore, Nagkesar (Mesua ferrea) is used for astringent, stomachic, cooling, carminative, expectorant, purgative, blood dysentery, piles,

leucorrhea, sudorific, antidysenteric, antirheumatic. Used in nausea, leprosy, fever, impotency, polydepsia. Moreover, Aparajita (Clitoria ternatea) is used for memory enhancing, antistress, anxiolytic, antidepressant, anticonvulsant, tranquilizing, and sedative properties. Jeera (Cuminum cyminum) is used for increase urine flow to relieve bloating, diarrhea, colic, bowel spasms, gas to start menstruation, aphrodisiac.
[0023] In still another embodiment of the invention, Liquorice (Glycyrrhiza glabra) is used to cure Itchy and inflamed skin, dyspepsia, recovery after surgery, canker sores, dental plaque, dry mouth, hepatitis, high cholesterol, stomach ulcers. Further, Suhaga (Borax) is used for arthritis, tonsillitis, PCOS, vaginal infections, open wounds, dandruff, acne, cardiovascular health. Furthermore, Jatamansi (Nardostachys jatamansi) is a neuroprotective, anti-stress, anti-depressant, anxiolytic, anti-cataleptic, anti-seizure (Anticonvulsant), antispasmodic, anti-inflammatory, antihypertensive, deodorant, antibacterial, antifungal (Jatamansi oil), carminative, stomachic, heart Tonic, mild diuretic (by exerting stimulant action on kidneys), anti-histaminic, mild laxative. Moreover, Musabbar (Alva) helps in muscle cramps, hypertension, regulates neurotransmitter levels, helps in haemoglobin formation, Maintains blood glucose levels.
[0024] In another embodiment of the invention the herbal formulation prepared through the disclosed process having Shatavari, Ashoka, Turmeric, Manjishtha,

Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar in dry herbal form provides effective balance in female hormone and relieve female hormonal imbalance. The combination is effective in dysmenorrhoea (pain and cramping during periods), amenorrhea, leucorrhoea, premenstrual symptoms, pelvic pain and weakness, menorrhagia (Excessive bleeding and pain), perimenopausal discomfort, low fertility and PCOS. The effectiveness of the formulation depends on the ratio of the ingredients in the mixture, as the disclosed ingredients are having therapeutical effect, while the combination of all ingredients, is having superior efficacy compared to individual ingredients. Furthermore, there are plenty of other herbs having medicinal effect in relation to ayurvedic treatment of issue relating to female hormonal imbalance, while the herbal formulation of Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar is having superior therapeutic effect in relieving female hormonal imbalance.
[0025] Further, the composition of the invention is a synergistic composition in that it is not a mere admixture of various herbs. The composition of the invention represents a delicate balance of herbs blended in a specific concentration so as to achieve specific results such as being suitable for relieving female hormonal imbalance. When all the herbs of the composition are combined, they exhibit surprising and unexpected properties.

[0026] In another embodiment of the invention the process of preparation of the herbal formulation is disclosed. The raw ingredients Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar in original dry herbal form are procured, got together and mixed (in respective ratios) for further process of grinding through pulverization Further, the mixture is grinded through pulveriser wherein the mixed formulation (i.e the dry herbal raw ingredients mixed together in respective ratios) is then put through the pulveriser for grinding. The griding process leads to a loss of ~10% of the weighted formulation in this step. Further, the grinded mixture is processed by sifting, wherein the matter is passed through the sift for gaining even more fine powder, where there might be a loss of ~1% of the net weight and it removes any granules or larger particles. Moreover, post sifting the entire mixture is even further mixed, to ensure thorough mixing of the ingredients and to gain uniformity.
[0027] In another embodiment of the invention the process of preparation of capsule of the herbal formulation is disclosed. Wherein the Ingredients in the form of dry herbal extracts are procured. The dry extract is made via a standard extraction process using a “Clavenger Apparatus” are process; then a quath (“boiled syrup formulation”) is formed; the quath is dried and converted to dry extract which is a concentrated dry fine powder of the herb. Further, the dry extracts of the ingredients are then mixed as

per respective ratios, the mixed formulated ingredients are then undergo sifting to remove larger particles and achieve more fineness, which also removes any contaminants. The mixture is then further mixed to achieve uniformity and then excipients are added in respective ratios (for better adsorption within the body). Moreover, the final mixture is then filled in the capsules through standard encapsulation process using capsules of either gelatin or veg. (rice) based.
[0028] In general, in another embodiment of the invention, the prescribed dosage of 1-2 capsules twice daily must be taken for 3 months for visible effects. [0029] In yet another aspect of the present invention, the herbal formulation can be administered orally in the form of a tablet, capsule, powder or liquid or in the form of nutritional supplement.
[0030] In another aspect of the present invention, in the case of chronic or severe conditions, the dosage may be increased for a few days to obtain best results.
[0031] In yet another aspect of the present invention, the herbal formulation for treatment of regulating blood sugar level is disclosed. The formulation comprises of Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi, Musbbar and pharmaceutically acceptable excipient. The formulation can be administered orally in the form of a tablet, capsule, powder or liquid.

[0032] In an exemplary embodiment of the invention the formulation comprises of Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar are in the ratio of 9:7:7:7:7:7:7:7:7:7:7:6:2:4.
[0033] In still another embodiment of the invention, preparation of the herbal formulation for regulating blood sugar level and digestive system, the preparation comprises steps of : mixing of Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar; grinding the mixed formulation through pulverization; sifting the grinded formulation for gaining more fine powder; and further mixing the grinded formulation to obtain a uniform herbal formulation.
[0034] In still another aspect of the invention, the invention provides advantages in respect of following diseases:
• Hormonal imbalance
• Dysmenorrhoea (pain and cramping during periods)
• Amenorrhea (Absence of periods)
• Leucorrhoea

• Premenstrual symptoms
• Pelvic pain & weakness
• Menorrhagia (Excessive bleeding and pain)
• Perimenopausal discomfort
• Low fertility
• PCOS and
• The formulation can be used to prevent, control or treat any conditions arising out of hormonal imbalance in female by using the herbal formulation prepared with different ratio of ingredients.
[0035] The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.
[0036] While, the following description is presented to enable a person of ordinary skill in the art to make and use the invention and is provided in the context of the

requirement for obtaining a patent. The present description is the best presently-contemplated method for carrying out the present invention. Various modifications to the preferred embodiment will be readily apparent to those skilled in the art and the generic principles of the present invention may be applied to other embodiments, and some features of the present invention may be used without the corresponding use of other features. Accordingly, the present invention is not intended to be limited to the embodiment shown but is to be accorded the widest cope consistent with the principles and features described herein.
[0037] Many modifications of the present invention will be apparent to those skilled in the arts to which the present invention applies. Further, it may be desirable to use some of the features of the present invention without the corresponding use of other features.
[0038] Accordingly, the foregoing description of the present invention should be considered as merely illustrative of the principles of the present invention and not in limitation thereof.

CLAIMS What is Claimed is:
1. A herbal formulation for relieving female hormonal imbalance, the formulation comprises of Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar.
2. The Herbal formulation as claimed in claim 1, wherein the formulation comprises of Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar in the ratio of 9:7:7:7:7:7:7:7:7:7:7:6:2:4.
3. The herbal formulation as claimed in claim 1, wherein the formulation is in the form of power or capsule and optionally comprises pharmaceutical excipients.
4. A method of preparation of herbal formulation for relieving female hormonal imbalance, the preparation comprises steps of :
mixing of Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar;
grinding the mixed formulation through pulverization;
sifting the grinded formulation for gaining more fine powder; and
further mixing the grinded formulation to obtain a uniform herbal formulation.

5. The method as claimed in claim 4, wherein the preparation comprises of Shatavari, Ashoka, Turmeric, Manjishtha, Bilva, Jharberi, Lodhra, Nagkesar, Aparajita, Jeera, Liquorice, Suhaga, Jatamansi and Musbbar in the ratio of 9:7:7:7:7:7:7:7:7:7:7:6:2:4.
6. The method as claimed in claim 4, wherein the formulation is prepared in the form of power or capsule and optionally comprises pharmaceutical excipients.