Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)
NCT ID: NCT01138930
Last Updated: 2013-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2010-06-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Berberine
Berberine
1.5g daily for 3 month
Placebo
Placebo
placebo daily
Interventions
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Berberine
1.5g daily for 3 month
Placebo
placebo daily
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
35 Years
FEMALE
No
Sponsors
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Heilongjiang University of Chinese Medicine
OTHER
Responsible Party
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Xiaoke Wu
Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital
Principal Investigators
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Lihui Hou, MD.
Role: STUDY_CHAIR
The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Xiaoke Wu, MD.PhD.
Role: STUDY_CHAIR
The First Affliated Hospital,Heilongjiang University of Chinese Medicine
Locations
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Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
First Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Forth Affiliated Hospital of Harbin Medcal University
Harbin, Heilongjiang, China
Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Harbin, Heilongjiang, China
Countries
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Central Contacts
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Facility Contacts
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Hongxia Ma, MD
Role: primary
Zhuoran Wang, MD
Role: primary
Shiyu Han, MD
Role: primary
References
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Zhang Y, Sun J, Zhang YJ, Chai QY, Zhang K, Ma HL, Wu XK, Liu JP. The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial. Trials. 2016 Oct 21;17(1):512. doi: 10.1186/s13063-016-1633-5.
Li Y, Ma H, Zhang Y, Kuang H, Ng EH, Hou L, Wu X. Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial. Trials. 2013 Jul 18;14:226. doi: 10.1186/1745-6215-14-226.
Other Identifiers
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berberine2010
Identifier Type: -
Identifier Source: org_study_id
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