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Trial record 16 of 21 for:    fenugreek

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
Sponsor:
Information provided by (Responsible Party):
Chemical Resources

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.

Condition or disease Intervention/treatment Phase
PCOS Dietary Supplement: Furocyst Not Applicable

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.

  1. Oral contraceptives, periodic progesterone withdrawal for the control of irregular menstruation.
  2. Oral contraceptives, Metformin and anti-androgens (Spironolactone) for the

    Hirsutism.

  3. 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 .
  4. 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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts

Arm Intervention/treatment
Experimental: Furocyst
Furocyst 500mg capsule, BD
Dietary Supplement: Furocyst
Furocyst caps BD
Other Name: Standardized fenugreek extract




Primary Outcome Measures :
  1. Reduction in Overian volume & Number of overian Cysts [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Restoration of normal menstrual cycle [ Time Frame: 12 weeks ]


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:   Yes
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

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): NCT02703064


Locations
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India
Dept of Obs & Gynae, King George's Medical University, Lucknow, UP, India
Lucknow, Uttar Pradesh, India, 226003
Sponsors and Collaborators
Chemical Resources
Investigators
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Principal Investigator: Dr. Pushpalata Sankhwar, M.S. Dept of Obs & Gynae,King George's Medical University, Lucknow, UP, India

Publications:
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Responsible Party: Chemical Resources
ClinicalTrials.gov Identifier: NCT02703064     History of Changes
Other Study ID Numbers: Protocol No. CR-PCOS/1-15
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chemical Resources:
Furocyst
PCOS

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