Overview

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

Status:
Unknown status

Trial end date:
2013-06-01

Target enrollment:
0

Participant gender:
Female

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Heilongjiang University of Chinese Medicine

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 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.