Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)

Last updated: May 8, 2013
Sponsor: Heilongjiang University of Chinese Medicine
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Obesity

Diabetes Prevention

Reproductive Health

Treatment

N/A

Clinical Study ID

NCT01138930
berberine2010
  • Ages 18-35
  • Female

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. Age of women between 18 and 35 years.

  2. Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism.

  3. Body mass index (BMI) equal to or greater than 23 kg/m2.

  4. 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

  1. Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months.

  2. Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome

  3. Patients with known sever organ dysfunction or mental illness.

Study Design

Total Participants: 120
Study Start date:
June 01, 2010
Estimated Completion Date:
June 30, 2013

Connect with a study center

  • Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .

    Harbin, Heilongjiang 150040
    China

    Active - Recruiting

  • First Affliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

  • Forth Affiliated Hospital of Harbin Medcal University

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

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