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Clinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT02789488
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Chemical Resources

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.

Condition or disease Intervention/treatment Phase
Poly Cystic Ovary Syndrome Dietary Supplement: Fenugreek seeds extract 500 mg Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Furocyst in Patients With Poly Cystic Ovary Syndrome
Study Start Date : September 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts

Arm Intervention/treatment
Furocyst
Furocyst one caps BID
Dietary Supplement: Fenugreek seeds extract 500 mg
Furocyst one caps BID
Other Name: Furocyst




Primary Outcome Measures :
  1. Reduction in Ovary volume as assessed by ultrasound [ Time Frame: 12 weeks ]
    volume in cubic cms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789488


Sponsors and Collaborators
Chemical Resources
Investigators
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Principal Investigator: Dr Amrita Sarkari Jaipuriar, MS Garg Hospital,Goalghar .Gorakhpur,UP,India

Publications:
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Responsible Party: Chemical Resources
ClinicalTrials.gov Identifier: NCT02789488     History of Changes
Other Study ID Numbers: CR001/PCOS-5-13
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: September 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Syndrome
Ovarian Cysts
Disease
Pathologic Processes
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases