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Furocyst - Poly Cystic Ovary Syndrome Study

Primary Purpose

PCOS

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Furocyst
Sponsored by
Chemical Resources
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for PCOS focused on measuring Furocyst, PCOS

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Furocyst

Arm Description

Furocyst 500mg capsule, BD

Outcomes

Primary Outcome Measures

Reduction in Overian volume & Number of overian Cysts

Secondary Outcome Measures

Restoration of normal menstrual cycle

Full Information

First Posted
September 29, 2015
Last Updated
September 14, 2017
Sponsor
Chemical Resources
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1. Study Identification

Unique Protocol Identification Number
NCT02703064
Brief Title
Furocyst - Poly Cystic Ovary Syndrome Study
Official Title
To Study the Efficacy and Safety of Furocyst in Poly Cystic Ovary Syndrome Patients (PCOS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 26, 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (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 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.
Detailed Description
The symptoms of PCOS are anovulation, resulting in irregular menstruation (amenorrhea and oligomenorrhea) ovulation-related infertility, and polycystic ovaries, often associated with obesity, Type 2 diabetes, and high cholesterol levels. The level of serum insulin and insulin resistance are higher in women with PCOS (Hyperinsulinemia).Insulin resistance, defined as the decreased insulin mediated glucose utilization it is more common in women with PCOS up to 50 % in both obese and non obese women . It has also been recognized that some women with this syndrome will have PCO without clinical evidence of androgen excess, but will display evidence of ovarian dysfunction . It is believed to be that, the Hyperinsulinemia of PCOS stimulates the androgens production and increase the activity by decreasing the sex hormone binding globulin (SHBG) thus increasing the free active testosterone level and by the activating the cytochrome P 450 C 17 alpha enzymatic system that controls androgens production. The diagnosis of PCOS is based on Hyperandrogenism and chronic anovulation in the absence of specific pituitary or adrenal disease , and have disrupted ovulatory function with chronic oligomenorrhea (cycle length > 35 day) or amenorrhea (cycle length > 12 week) and typical appearance of polycystic ovaries by ultrasound according to the criteria of the Rotterdam consensus meeting 2003 for diagnosis of PCOS. The different diagnostic tests needed to adequately assess for the possibility of PCOS e.g. Pregnancy test, TSH level (for Hyperthyroidism), Prolactin test (for Hyperprolactinemia), Total testosterone (for ovarian tumor) and some tests forevaluating the insulin resistance syndrome in women: Waist circumference (>88 cm), Triglycerides (>150 mg/dL), HDL Cholesterol (<50 mg/dL), Blood pressure (>130/85) and Fasting glucose (>110 mg/dL). Fasting glucose- to- insulin ratio and 2 hour oral glucose tolerance test (2h- OGTT 140 - 199 mg/dL) may be better predictor of insulin resistance . The management of the PCOS is symptoms specific e.g. Oral contraceptives, periodic progesterone withdrawal for the control of irregular menstruation. Oral contraceptives, Metformin and anti-androgens (Spironolactone) for the Hirsutism. Clomiphene citrate, Metformin and thiazolidinediones for infertility. A recent study shown that, the combination of Metformin plus Clomiphene citrate should be considered as the First line treatment for infertile women with PCOS . Metformin and lifestyle modification for the insulin resistance and diabetes mellitus. All these management options are only for "acute" not for "chronic". The long-term management approach for the PCOS is needed which will be based on management of most affecting factor insulin resistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS
Keywords
Furocyst, PCOS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open level
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Furocyst
Arm Type
Experimental
Arm Description
Furocyst 500mg capsule, BD
Intervention Type
Dietary Supplement
Intervention Name(s)
Furocyst
Other Intervention Name(s)
Standardized fenugreek extract
Intervention Description
Furocyst caps BD
Primary Outcome Measure Information:
Title
Reduction in Overian volume & Number of overian Cysts
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Restoration of normal menstrual cycle
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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Pushpalata Sankhwar, M.S.
Organizational Affiliation
Dept of Obs & Gynae,King George's Medical University, Lucknow, UP, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Obs & Gynae, King George's Medical University, Lucknow, UP, India
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2895373
Citation
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.
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Furocyst - Poly Cystic Ovary Syndrome Study

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