NCT02093650Unknown3 期
Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial
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
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
Patsama Vichinsartvichai
MD.
Navamindradhiraj University
研究点 (1)
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