Furocyst - Poly Cystic Ovary Syndrome Study

NCT02703064 | Completed

• 1 other identifier: Protocol No. CR-PCOS/1-15
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Poly cystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, affecting approximately 5%-10% of all females worldwide . PCOS is a hormonal disorder that involves multiple organ systems within the body. Its cardinal features are Hyperandrogenism and polycystic ovary (PCO) morphology. Women with PCOS may complains about irregular menstrual periods or heavy menstrual bleeding, infertility, excessive growth of coarse facial and body hair, obesity, oiliness of the skin, seborrhea, and cystic acne.

Conditions

PCOS

Keywords

Furocyst; PCOS

Outcome Measures

Primary Outcomes (1)

• Reduction in Overian volume & Number of overian Cysts

  12 weeks

Secondary Outcomes (1)

• Restoration of normal menstrual cycle

  12 weeks

Study Arms (1)

Furocyst

EXPERIMENTAL

Furocyst 500mg capsule, BD

Dietary Supplement: Furocyst

Interventions

Furocyst DIETARY_SUPPLEMENT

Furocyst caps BD

Also known as: Standardized fenugreek extract

Furocyst

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women between 18-45 years of age and BMI less than 42
• Diagnosed with PCOS by Rottadom Criteria
• Adequate hepatic, renal, Cardiac and hematological functions.
• Patients willing to Participate and give informed consent in writing as well as in audio-visual form for the study.
• Stable weight for last two months (Change of weight\<3kg)

You may not qualify if:

• Male
• Post menopausal women
• Women with hysterectomy
• Hyperprolactinemia
• Patients with congenital adrenal hyperplasia
• Patients suffering from Cushing's syndrome
• Acute or chronic Medical illness including Hepatic, Cardiac or renal insufficiency, COPD,Gastrointestinal Disorders
• Uncontrolled Hypertensive or known Diabetics on drugs
• Use of oral contraceptives or HRT for last three months
• Smoking or drug addicts or with psychiatric illness
• 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)
• Pregnant or lactating mothers

Sponsors & Collaborators

• Chemical Resources: lead

Study Sites (1)

Dept of Obs & Gynae, King George's Medical University, Lucknow, UP, India

Lucknow, Uttar Pradesh, 226003, India

Location

Related Publications (1)

• Polson DW, Adams J, Wadsworth J, Franks S. Polycystic ovaries--a common finding in normal women. Lancet. 1988 Apr 16;1(8590):870-2. doi: 10.1016/s0140-6736(88)91612-1.

  PMID: 2895373 BACKGROUND

Study Officials

• Dr. Pushpalata Sankhwar, M.S.

  Dept of Obs & Gynae,King George's Medical University, Lucknow, UP, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open level

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: March 9, 2016
• Study Start: March 26, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 15, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)