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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Heilongjiang University of Chinese Medicine.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01138930
First received: June 7, 2010
Last updated: May 8, 2013
Last verified: May 2013

June 7, 2010
May 8, 2013
June 2010
June 2013   (Final data collection date for primary outcome measure)
Whole body insulin action [ Time Frame: 3 months ]
Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp
  • Glucose Disposal Rate [ Time Frame: 3 months ]
    measured by hyperinsulinemic euglycemic clamp
  • Measurement of sex steroids [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01138930 on ClinicalTrials.gov Archive Site
  • Oral glucose tolerance test (OGTT) [ Time Frame: 3 months ]
  • Ovarian androgen biosynthesis [ Time Frame: 3 months ]
  • Hormonal profile [ Time Frame: 3 months ]
  • Fasting lipid metabolic profile [ Time Frame: 3 months ]
  • Renal and liver function tests [ Time Frame: 3 months ]
  • Adverse events [ Time Frame: 3 months ]
  • 6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment. [ Time Frame: Three months ]
  • glucose levels [ Time Frame: 3 months ]
    Fasting glucose levels and OGTT 2h glucose levels
  • Serum Triglycerides [ Time Frame: 3 months ]
  • HDL-c [ Time Frame: 3 months ]
  • ovulation rate [ Time Frame: 6 month ]
Not Provided
Not Provided
 
Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)
Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Obesity
  • Drug: Berberine
    1.5g daily for 3 month
  • Drug: Placebo
    placebo daily
  • Experimental: Berberine
    Intervention: Drug: Berberine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
June 2013
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01138930
berberine2010
Yes
Not Provided
Not Provided
Not Provided
Xiaoke Wu, Heilongjiang University of Chinese Medicine
Heilongjiang University of Chinese Medicine
Not Provided
Study Chair: Lihui Hou, MD. The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Study Chair: Xiaoke Wu, MD.PhD. The First Affliated Hospital,Heilongjiang University of Chinese Medicine
Heilongjiang University of Chinese Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP