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Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS

18 Years
35 Years
Open (Enrolling)
Polycystic Ovary Syndrome, Obesity

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Trial Information

Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS

Inclusion Criteria

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Whole body insulin action

Outcome Description:

Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Lihui Hou, MD.

Investigator Role:

Study Chair

Investigator Affiliation:

The First Affliated Hospital,Heilongjiang University of Chinese Medicine .


China: Ministry of Health

Study ID:




Start Date:

June 2010

Completion Date:

June 2013

Related Keywords:

  • Polycystic Ovary Syndrome
  • Obesity
  • Polycystic Ovary Syndrome
  • Obesity
  • Obesity
  • Polycystic Ovary Syndrome