Status:
UNKNOWN
Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
Heilongjiang University of Chinese Medicine
Conditions:
Polycystic Ovary Syndrome
Obesity
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
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 polycysti...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01138930
Start Date
June 1 2010
End Date
June 1 2013
Last Update
May 10 2013
Active Locations (4)
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1
Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
2
First Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
3
Forth Affiliated Hospital of Harbin Medcal University
Harbin, Heilongjiang, China, 150001
4
Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Harbin, Heilongjiang, China, 150040