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临床试验/NCT01138930
NCT01138930Unknown不适用

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

Heilongjiang University of Chinese Medicine4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
4
主要终点
Whole body insulin action

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Berberine

Experimental

干预措施: Berberine (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Whole body insulin action

时间窗: 3 months

Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp

次要结局

  • Oral glucose tolerance test (OGTT)(3 months)
  • Ovarian androgen biosynthesis(3 months)
  • Hormonal profile(3 months)
  • Fasting lipid metabolic profile(3 months)
  • Renal and liver function tests(3 months)
  • Adverse events(3 months)
  • 6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment.(Three months)

研究者

发起方
Heilongjiang University of Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaoke Wu

Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital

Heilongjiang University of Chinese Medicine

研究点 (4)

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