Furocyst - Poly Cystic Ovary Syndrome Study
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|ClinicalTrials.gov Identifier: NCT02703064|
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : September 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|PCOS||Dietary Supplement: Furocyst||Not Applicable|
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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open level|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||To Study the Efficacy and Safety of Furocyst in Poly Cystic Ovary Syndrome Patients (PCOS)|
|Actual Study Start Date :||March 26, 2015|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Furocyst 500mg capsule, BD
Dietary Supplement: Furocyst
Furocyst caps BD
Other Name: Standardized fenugreek extract
- Reduction in Overian volume & Number of overian Cysts [ Time Frame: 12 weeks ]
- Restoration of normal menstrual cycle [ Time Frame: 12 weeks ]
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): NCT02703064
|Dept of Obs & Gynae, King George's Medical University, Lucknow, UP, India|
|Lucknow, Uttar Pradesh, India, 226003|
|Principal Investigator:||Dr. Pushpalata Sankhwar, M.S.||Dept of Obs & Gynae,King George's Medical University, Lucknow, UP, India|