Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)
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ClinicalTrials.gov Identifier: NCT01138930
Verified May 2013 by Xiaoke Wu, Heilongjiang University of Chinese Medicine. Recruitment status was: Recruiting
: June 8, 2010
Last Update Posted
: May 10, 2013
Heilongjiang University of Chinese Medicine
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine
Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.
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Ages Eligible for Study:
18 Years to 35 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age of women between 18 and 35 years.
Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism.
Body mass index (BMI) equal to or greater than 23 kg/m2.
With no desire of children within 6 month. PCOS is defined by the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with presence of ≥12 antral follicles (≤9mm) and/or ovarian volume >10 ml on transvaginal scanning, and/or clinical/biochemical hyperandrogenism. Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5.
Exclusion criteria are
Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months.
Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome
Patients with known sever organ dysfunction or mental illness.