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临床试验/NCT02093650
NCT02093650Unknown3 期

Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial

Navamindradhiraj University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年3月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
60
试验地点
1
主要终点
The changes in Kupperman Index
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms

详细描述

Compare the treatment efficacy of black cohosh extract 80 mg/day an placebo for moderate to severe menopausal symptoms with Kupperman menopausal index and MENQOL

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
40 Years 至 —（Adult, Older Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •Age at least 40 years
  • •Peri or post menopause
  • •Moderate to severe menopausal symptoms (Kupperman index at least 20)

排除标准

  • •Use hormonal treatment or other treatments within 4 weeks
  • •Use atorvastatin azathioprine or cyclosporin within 4 weeks
  • •BMI at least 30 kg m2
  • •Allergic to drug or components
  • •Liver disease or abnormal liver function test
  • •Psychiatric disease
  • •Alcoholic or drug abuse
  • •Vegetarian

研究组 & 干预措施

Black cohosh extract

Active Comparator

black cohosh extract 80 mg daily

干预措施: black cohosh extract (Drug)

Placebo

Placebo Comparator

Matching placebo

干预措施: Placebo (Drug)

结局指标

主要结局

The changes in Kupperman Index

时间窗: baseline, week 4, week 8 and week 12

Kupperman index questionnaire at baseline, 4, 8 and 12 weeks

次要结局

  • The changes in daily hot flushes frequency(baseline, week 4, week 8 and week 12)
  • Global satisfaction(week 12)
  • adverse events(week 4, week 8 and week 12)
  • A change in liver function test(baseline and week 12)
  • A change in MENQOL(baseline and week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patsama Vichinsartvichai

MD.

Navamindradhiraj University

研究点 (1)

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