NCT01487694Unknown3 期
Cimicifuga Racemosa Rhizome and Root Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women: a Randomized 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
- 54
- 试验地点
- 1
- 主要终点
- Mean differences of Kupperman index
研究概览
简要总结
Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with menopausal symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.
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
- •Thai women, aged ≥ 40 years
- •Peri- or postmenopause
- •Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20
排除标准
- •Using any drugs or hormonal treatment within 1 month before enrollment
- •BMI ≥ 30 kg/m2
- •Allergic to drugs or any ingredient
- •Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL
- •Psychiatric disease
- •Alcohol consumption or any elicit drug use
- •Vegetarian (may consume more phytoestrogen)
研究组 & 干预措施
Cimicifuga racemosa
Experimental
patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg)
干预措施: cimicifuga racemosa (Drug)
Placebo
Placebo Comparator
Placebo containing no active ingredient which match the drug in bottle, shape, color and smell
干预措施: placebo (Drug)
结局指标
主要结局
Mean differences of Kupperman index
时间窗: 12 weeks
次要结局
- Frequencies of menopausal symptoms(12 weeks)
- Compliance(12 weeks)
- adverse events(12 weeks)
- Mean differences of liver function test(12 weeks)
- quality of life(12 weeks)
- Overall satisfaction(12 weeks)
研究者
研究点 (1)
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