Clinical Evaluation of Furocyst in Patients With Poly Cystic Ovary Syndrome
Efficacy and Safety of Furocyst in Patients With Poly Cystic Ovary Syndrome
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2013
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 3, 2016
CompletedJune 3, 2016
September 1, 2013
10 months
April 20, 2016
May 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in Ovary volume as assessed by ultrasound
volume in cubic cms
12 weeks
Study Arms (1)
Furocyst
OTHERFurocyst one caps BID
Interventions
Furocyst one caps BID
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
PMID: 15788499BACKGROUNDSchroder 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.
PMID: 14740344BACKGROUNDHassanzadeh 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.
PMID: 24250624BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Amrita Sarkari Jaipuriar, MS
Garg Hospital,Goalghar .Gorakhpur,UP,India
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2016
First Posted
June 3, 2016
Study Start
September 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 3, 2016
Record last verified: 2013-09
Data Sharing
- IPD Sharing
- Will not share