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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
  Purpose
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.

Condition Intervention
Polycystic Ovary Syndrome
Obesity
Drug: Berberine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS

Resource links provided by NLM:


Further study details as provided by Heilongjiang University of Chinese Medicine:

Primary Outcome Measures:
  • Whole body insulin action [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp


Secondary Outcome Measures:
  • Oral glucose tolerance test (OGTT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ovarian androgen biosynthesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Hormonal profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Fasting lipid metabolic profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Renal and liver function tests [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment. [ Time Frame: Three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Berberine Drug: Berberine
1.5g daily for 3 month
Placebo Comparator: Placebo Drug: Placebo
placebo daily

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138930

Locations
China, Guangdong
Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
China, Heilongjiang
First Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Forth Affiliated Hospital of Harbin Medcal University
Harbin, Heilongjiang, China, 150001
Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Harbin, Heilongjiang, China, 150040
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT01138930     History of Changes
Other Study ID Numbers: berberine2010 
Study First Received: June 7, 2010
Last Updated: May 8, 2013
Health Authority: China: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Heilongjiang University of Chinese Medicine:
Polycystic Ovary Syndrome
Obesity

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 02, 2016