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Clinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome

Primary Purpose

Poly Cystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fenugreek seeds extract 500 mg
Sponsored by
Chemical Resources
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Poly Cystic Ovary Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Premenopausal women between 18-45 years of age and BMI less than 42
  • Diagnosed with PCOS
  • Adequate hepatic, renal and hematological functions
  • Patients willing to give informed consent in writing

Exclusion Criteria:

  • Males
  • Post menopausal women
  • Women with hysterectomy
  • Patients with congenital adrenal hyperplasia
  • Patients suffering from Cushing's syndrome
  • Patients diagnosed with androgen secreting tumors
  • Patients with thyroid dysfunction (T3, T4 level is higher than that in normal women of reproductive age)
  • Patients with Hypo-gonadotropic and Hypo-gonadism (central origin of ovarian dysfunction)
  • Pregnancy or desire for pregnancy or lactating mothers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Furocyst

    Arm Description

    Furocyst one caps BID

    Outcomes

    Primary Outcome Measures

    Reduction in Ovary volume as assessed by ultrasound
    volume in cubic cms

    Secondary Outcome Measures

    Full Information

    First Posted
    April 20, 2016
    Last Updated
    May 30, 2016
    Sponsor
    Chemical Resources
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02789488
    Brief Title
    Clinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome
    Official Title
    Efficacy and Safety of Furocyst in Patients With Poly Cystic Ovary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chemical Resources

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Poly cystic ovary syndrome (PCOS) is a disease which is prevalent in women of reproductive age facing obesity along with increased risk of type-2 diabetes and high cholesterol levels. The genetically determined cause of the PCOS includes disturbed levels of insulin and androgens. Standardized fenugreek seed extract (Furocyst) contains compounds such as saponins & flavonoids which act on the insulin and indirectly helps to regulate the androgen levels in the body.
    Detailed Description
    Polycystic ovary syndrome is considered as clinical and public health consequence involving increase in number of cysts in women at reproductive age. These cysts are under-developed sacs in which eggs are developed. In PCOS, these sacs are unable to release an egg which means ovulation doesn't take place. The estimated 5-10% prevalence of PCOS is reported in women of reproductive age. A study from Spain also reported that 28.3% prevalence rate of PCOS is among 113 overweight or obese women who were referred to an endocrinology clinic for weight loss. This data was compared with a previously reported prevalence of 6.5% which suggests that the prevalence of PCOS might be markedly increasing with obesity. PCOS impacts significantly on various hormonal cycles. With PCOS, luteinizing hormone (LH) levels become higher than follicle stimulating hormone (FSH) levels. Because of this increase in LH levels, the LH surge does not take place and ovulation doesn't carry out which results in irregular menstrual cycle. The irregular menstrual period produces oligomenorrhea (few menstrual periods) or amenorrhea (no menstrual periods) and infertility due to irregular or lack of ovulation. PCOS also produces high levels of masculinizing hormones with symptoms of acne and hirsutism, hypermenorrhea involving heavy and prolonged menstrual periods and androgenic alopecia (increase hair thinning and diffused hair loss). The other metabolic syndromes associated with PCOS are increased risk of type 2 diabetes, high cholesterol levels and obesity. These complications arise because of the genetically determined cause of the PCOS i.e. hyper- secretion of androgens from the ovary which favours excess luteinizing hormone (LH) secretion and insulin resistance. However, insulin resistance with or without a genetic mutation may be the initiator, followed by hyper-androgenism. Thus, insulin resistance is an important contributing factor to abnormal steroidogenesis in PCOS because hyper-insulinemia stimulates the pathway of insulin like growth factor-I (IGF-I) in theca cells of the ovary by cross-reacting with the receptors of IGF. Stimulation of the ovarian theca cells increases the production of androgens (eg, testosterone, androstenedione) which in turn, blocks the down-regulation of androgens by LH surge and leads to the hyper-androgenic environment in the ovary. Because of a decreased level of FSH relative to LH, the ovarian granulosa cells cannot aromatize the androgens to estrogens, which lead to decreased estrogen levels and results in anovulation. Treatments for PCOS are chosen based on woman's symptoms, age and future pregnancy plans which may include birth control pills to regulate menstruation, insulin-sensitizing medications, ovulation induction to treat infertility, androgen-blocking medications, topical anti-hair-growth medications, etc. Standardized fenugreek (Trigonella foenum graecum) seed extract (Furocyst) plays an important role in the management of PCOS. It improves glucose-tolerance and insulin-sensitivity, thereby promoting weight loss and moderation of androgen levels in the blood. Standardized fenugreek seeds extract contains a group of furostanolic saponins, derived from fenugreek seeds by an innovative process. It contains rich variety of saponins and flavonoids which have been known to lower the blood lipid levels and play valuable role in improving insulin sensitivity. Standardized fenugreek seeds extract is a dual insulin-sensitizer. In the presence of high fiber furostanolic saponins, cells become more sensitive to insulin & an increase in number of insulin receptor sites occurs. These receptor sites are responsive to insulin to stimulate the cells ability to burn glucose. This decrease in insulin resistance helps in the management of PCOS. Considering the beneficial effects of standardized fenugreek seed extract, present study was conducted to evaluate the efficacy of fenugreek seeds extract in patients with poly cystic ovary syndrome by assessing reduction in ovarian volume and decrease in the number of ovarian cysts.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Poly Cystic Ovary Syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Furocyst
    Arm Type
    Other
    Arm Description
    Furocyst one caps BID
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fenugreek seeds extract 500 mg
    Other Intervention Name(s)
    Furocyst
    Intervention Description
    Furocyst one caps BID
    Primary Outcome Measure Information:
    Title
    Reduction in Ovary volume as assessed by ultrasound
    Description
    volume in cubic cms
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Premenopausal women between 18-45 years of age and BMI less than 42 Diagnosed with PCOS Adequate hepatic, renal and hematological functions Patients willing to give informed consent in writing Exclusion Criteria: Males Post menopausal women Women with hysterectomy Patients with congenital adrenal hyperplasia Patients suffering from Cushing's syndrome Patients diagnosed with androgen secreting tumors Patients with thyroid dysfunction (T3, T4 level is higher than that in normal women of reproductive age) Patients with Hypo-gonadotropic and Hypo-gonadism (central origin of ovarian dysfunction) Pregnancy or desire for pregnancy or lactating mothers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr Amrita Sarkari Jaipuriar, MS
    Organizational Affiliation
    Garg Hospital,Goalghar .Gorakhpur,UP,India
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15788499
    Citation
    Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
    Results Reference
    background
    PubMed Identifier
    14740344
    Citation
    Schroder AK, Tauchert S, Ortmann O, Diedrich K, Weiss JM. [Insulin resistance in polycystic ovary syndrome]. Wien Klin Wochenschr. 2003 Dec 15;115(23):812-21. doi: 10.1007/BF03041041. German.
    Results Reference
    background
    PubMed Identifier
    24250624
    Citation
    Hassanzadeh Bashtian M, Emami SA, Mousavifar N, Esmaily HA, Mahmoudi M, Mohammad Poor AH. Evaluation of Fenugreek (Trigonella foenum-graceum L.), Effects Seeds Extract on Insulin Resistance in Women with Polycystic Ovarian Syndrome. Iran J Pharm Res. 2013 Spring;12(2):475-81.
    Results Reference
    background

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    Clinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome

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