US20170252391A1 - Single herb extract for the treatment of pcos (poly cystic ovarian syndrome) - Google Patents

Single herb extract for the treatment of pcos (poly cystic ovarian syndrome) Download PDF

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Publication number
US20170252391A1
US20170252391A1 US15/524,757 US201515524757A US2017252391A1 US 20170252391 A1 US20170252391 A1 US 20170252391A1 US 201515524757 A US201515524757 A US 201515524757A US 2017252391 A1 US2017252391 A1 US 2017252391A1
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pcos
extract
treatment
fenugreek
seeds
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Ashok Sharma
Kiran Tewari
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Kumar Goel Pawan
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Kumar Goel Pawan
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Assigned to KUMAR GOEL, PAWAN reassignment KUMAR GOEL, PAWAN ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SHARMA, Ashok, TEWARI, Kiran
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • Invention pertains to a single herb extractfor the effective treatment of PCOS (Poly Cystic Ovarian Syndrome) when given in oral dosage form as capsules of 500 mg, twice a day for period of time ranging from 30-90 days.
  • the extract is obtained from the seeds of a single herb viz. fenugreek, using a specific method of extraction.
  • PCOS Polycystic ovary syndrome
  • PCOS Polycystic ovary syndrome
  • the symptoms and severity of the disease vary greatly among women.
  • women with PCOS the physiological hyperinsulinaemia of adolescence may constitute a triggering factor that brings about the development of hyperandrogenism and anovulation.
  • Polycystic ovary syndrome has a basic etiology linked to an oxidative syndrome with insulin resistance.
  • the insulin resistance and consequent hyperinsulinaemia that are often associated with this syndrome play an important role not only in the pathogenesis of the syndrome itself, but also in the clinical symptomatology.
  • the chronic anovulation typical of PCOS results in an increased number of atretic follicles (which become cysts) and increased interstitial tissue in the stroma of the ovaries.
  • the problem is self-perpetuating in part because the atretic follicle becomes an androgenic follicle by a “default” mechanism: because of low aromatase activity in atretic follicles, androstenedione is preferentially metabolized to testosterone and hence to dihydrotestosterone within the ovary (Poison et al (1988): Polycystic ovaries—a common finding in normal women, The Lancet Volume 331, Issue 8590, 16 Apr. 1988, Pages 870-872D01: 10.1016/S0140-6736(88)91612-1).
  • compositions which are prescribed for PCOS include:
  • US Patent Application No. 20070298049 discloses a therapeutic agent for treating polycystic ovary syndrome (PCOS).
  • the agent comprises an extract of mushrooms as an active ingredientwhich exhibits few, if any, side effects. It is effective at inducing ovulation and is safely available for not only females who desire to bear children, but also for unmarried or young fernales.
  • the present invention is different from this prior art because it discloses an extract of furostanolicsaponins from fenugreek seeds to be given orally for the effective treatment of PCOS and does not contain any mushrooms or its extract at all.
  • US Patent Application No. 8062680 discloses a method for treating Polycystic Ovary Syndrome in a patient wherein the method comprising administering to the patient, together with pharmaceutically acceptable excipients, a composition comprising effective amounts of: natural herbs vizRhodiolarosea root extract, Panaxquinquefollus root extract, Pfaffapaniculada, etc. In contrast in the present invention, no such herbs are used at all. It is not a mixture of herbs but extract obtained from seeds of a single herb i.e. fenugreek.
  • WO Patent Application No. 2008119131 discloses a composition for PCOS treatment comprising several herbs viz. Shu Di Radix rehmanniae, Shan Yao Radix disocorea, Shan Yu Rou Fructuscorniofficinalis etc. In contrast. in the present invention, no such herbs are used at all. It is not a mixture of these herbs but a well-defined extract obtained from seeds of a single herb i.e. fenugreek.
  • CN Patent Application No. 102847081 (2011) discloses a complex mixture of herbsfor PCOS treatment.
  • the present invention is not a complex mixture of the herbs but a well-defined extract obtained from seeds of a single herb i.e. fenugreek. Fenugreek is not disclosed at all in the prior art patent.
  • WO Patent Application No 2013136257 (2012) discloses an herbal composition comprising a therapeutically effective amount of the extract of a plant belonging to Calophyllum species as an active ingredient and optionally, a pharmaceutically acceptable carrier.
  • the composition is formulated for oral administration in the form of a tablet, capsule or granules used in the treatment of a metabolic disorder like insulin resistance, hyperglycemia, type 2 diabetes, polycystic ovary syndrome or related.
  • a metabolic disorder like insulin resistance, hyperglycemia, type 2 diabetes, polycystic ovary syndrome or related.
  • an extract of furostanolicsaponins from fenugreek seeds is used which when given orally is effective in the treatment of PCOS.
  • Calophyllum species herbs are not used at all in the present invention.
  • Bashtian M. H. et al (2013) discloses effects of fenugreek seed extracts as adjuvant therapy with metformin, for the treatment of woman with PCOS. It was a prospective randomized, double-blind, placebo-controlled trial. Women were randomly allocated to receive hydroalcoholic extract of fenugreek seeds in capsules (500 mg dosage form) alongwith metformin (500 mg dosage form) and were assessed for improvement. The results showed significant decrease in PAO (polycystic appearing ovaries) in group. ( Evaluation of Fenugreek ( Trigonellafoenum - graceum L. ), Effects Seeds Extract on Insulin Resistance in Women with Polycystic Ovarian Syndrorne, Iran J Pharm Res. 2013 Spring; 12(2): 475-481).
  • Dried and fresh fenugreek seeds (25 Kg) were obtained from a commercial source. Seeds were washed in distilled water and were ground to a fine powder in a mixer under chilled conditions. Obtained powder was extracted by percolated white ethanol (70% w/w). The ethanol extract was lyophilized. The lyophilized extract was 2600 g. Twenty-five percent of tricalcium phosphate was added to dried extract. The powder mixture was crushed in a blinder and passed through a 20-mesh sieve. A capsule-filling machine was used thr preparation of powder containing capsules. The mean weight of each capsule was 525 mg (500 mg dried extract). Placebo capsules were filled (525 mg) with lactose powder colored with 1% tartrazine
  • the present invention is not a simple, hydroalcoholic extract obtained from fenugreek seeds but a purified extract of five furostanolicsaponins present in synergistic ratios and obtained from fenugreek seeds by a proprietary process developed by the inventor and for which the inventor has applied for grant of patent in India vide patent application number 1439/DEL/2008 Dated Jun. 17, 2008 entitled “A NOVEL PROCESS FOR EXTRACTION OF FUROSTANOLIC SAPONINS FROM FENUGREEK SEEDS” followed by international patent application number—PCT/lN2008/000559, subsequently filed and granted US patent number U.S. Pat. No. 8,217,165 B2 and divisional patent number U.S. Pat. No. 8,754,205 B2 , filed in EUROPE as application number EP 08 808 174. 0
  • Bashtian M. H. et al. does not anticipate the extract of present invention, which is a specifically defined synergistic extract of five furostanolicsaponins from fenugreek seeds, as per Table 1 above.
  • the significant differences between extract disclosed by Bashtian et al. and that of present invention are as per table below:
  • Another object of the present invention is to disclose a herbal extract for the treatment of PCOS comprising fivefurostanolicsaponinspresent in synergistic ratios and obtained from fenugreek seeds.
  • Yet another object of the invention is to disclose an oral composition obtained from extract of fenugreek seeds which leads to reduction in ovary volume, reduction in cyst size, complete dissolution of cyst and increased chances of pregnancy in infertile females.
  • a last object of the present invention is to disclose a method of treatment of PCOS comprising administering the said extract at a dosage of 1 gram per day in form of capsules of 500 mg twice a day, for a period of time ranging from 30-90 days, depending upon individual response and clinical assessment.
  • the invention discloses a single herb extract for the effective treatment of PCOS (Poly Cystic Ovarian Syndrome) when given in oral dosage form as capsules of 500 mg, twice a day for period of time ranging from 30-90 days.
  • the extract is obtained from the seeds of fenugreek using a specific method of extraction and comprises five furostanolicsaponins present in synergistic ratios as in Table 1 (Page 7) and having analytical profile as in FIG. 1 .
  • FIG. 1 Analytical fingerprint (LCMS profile) of extract of five furostanolicsaponins from fenugreek seeds
  • the present invention discloses a furostanolicsaponinsextract comprising a synergistic mixture of five compounds, obtained from fenugreek seeds and suitable for the treatment of PCOS when given orally.
  • the composition of the extract is given in Table 1 above and the analytical profile is disclosed in FIG. 1 .
  • Dosage forms of the above formulation were prepared in form of 500 mg capsules of the powder. Same were evaluated for clinical efficacy in the treatment of PCOS, after due approval of the ethical committee. Dosage given was 2 capsules per day, morning and evening after meals. Duration of administration of the extract varied between 30 days to 90 days (3 months). Number of subjects participating in the study was 50 and age group was 18-45years.Results of the treatment are given below:
  • the extract is made into dosage forms of capsules of 500 mg each. When administered orally twice a day for periods varying between 30-90 days, the extract provided effective results in the treatment of PCOS.
  • Novelty discloses a novel herbal extract derived from a single herb and its method of use for the treatment of PCOS which has not been disclosed in the prior art.
  • the extract comprises a synergistic mixture of five furostanolicsaponins extracted from seeds of a single herb viz. fenugreek (Table 1 at Page 7 and FIG. 1 ).
  • the extract when given orally at a dose of 1 gram per day (500 mg capsules, twice a day) for a period of time ranging from 30-90 daysis effective in the treatment of PCOS.
  • inventive step lies in the technical advancement of knowledge for treatment of PCOS using extract obtained from a single herband disclosure of its method of use (dosage per day for a fixed period of time i.e. 1 gram per day in form of 500 mg capsules, taken twice a day for period ranging from 30-90 days, as per clinical advise and assessment based on patient response).
  • the novel extract is isolated from seedsof a single herb viz. fenugreek and comprises a synergistic mixture of five furostanolicsaponins(Table 1 at Page 7 and FIG. 1 ) which are effective in the treatment of PCOS when given in appropriate dosage.
  • the said extract is suitable for the treatment of PCOS and can be manufactured on industrial scale.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Natural Medicines & Medicinal Plants (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Reproductive Health (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Mycology (AREA)
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  • Nutrition Science (AREA)
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  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
US15/524,757 2014-12-16 2015-02-11 Single herb extract for the treatment of pcos (poly cystic ovarian syndrome) Abandoned US20170252391A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN3718/DEL/2014 2014-12-16
IN3718DE2014 2014-12-16
PCT/IN2015/000079 WO2016098120A2 (en) 2014-12-16 2015-02-11 Single herb extract for the treatment of pcos (poly cystic ovarian syndrome)

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PCT/IN2015/000079 A-371-Of-International WO2016098120A2 (en) 2014-12-16 2015-02-11 Single herb extract for the treatment of pcos (poly cystic ovarian syndrome)

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US17/007,180 Continuation US11844821B2 (en) 2014-12-16 2020-08-31 Fenugreek extract for the treatment of poly cystic ovarian syndrome (PCOS)

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US17/007,180 Active 2035-11-03 US11844821B2 (en) 2014-12-16 2020-08-31 Fenugreek extract for the treatment of poly cystic ovarian syndrome (PCOS)

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US (2) US20170252391A1 (zh)
EP (1) EP3233100B1 (zh)
JP (1) JP6465974B2 (zh)
CN (1) CN109152729B (zh)
PL (1) PL3233100T3 (zh)
WO (1) WO2016098120A2 (zh)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009153800A1 (en) * 2008-06-17 2009-12-23 Pawan Kumar Goel A novel process for extraction of furostanolic saponins from fenugreek seeds
WO2010140165A1 (en) * 2009-06-01 2010-12-09 Kumar Pawan Goel A novel antidiabetic furostanolic saponin rich (fsr) fraction from fenugreek seeds

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0329667D0 (en) * 2003-12-22 2004-01-28 King S College London Core 2 GlcNAc-T inhibitor
SG10201704221XA (en) * 2012-12-05 2017-06-29 Ge Nutrients Inc Use of fenugreek extract to enhance female libido
CN104083749A (zh) * 2014-07-31 2014-10-08 李福荣 一种治疗多囊卵巢综合征的中药

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009153800A1 (en) * 2008-06-17 2009-12-23 Pawan Kumar Goel A novel process for extraction of furostanolic saponins from fenugreek seeds
WO2010140165A1 (en) * 2009-06-01 2010-12-09 Kumar Pawan Goel A novel antidiabetic furostanolic saponin rich (fsr) fraction from fenugreek seeds

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JP2018528155A (ja) 2018-09-27
CN109152729A (zh) 2019-01-04
PL3233100T3 (pl) 2021-11-08
US20210093686A1 (en) 2021-04-01
CN109152729B (zh) 2021-10-29
EP3233100A4 (en) 2019-08-14
WO2016098120A3 (en) 2018-07-12
WO2016098120A2 (en) 2016-06-23
JP6465974B2 (ja) 2019-02-06
EP3233100B1 (en) 2021-06-30
US11844821B2 (en) 2023-12-19
EP3233100A2 (en) 2017-10-25

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