NCT01613183Unknown不适用
Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- change from baseline in Total Sleep Time (TST) at 4 weeks
研究概览
简要总结
The objective of this study is to screen the effective core formulation in insomnia treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 65 years,
- •meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) of insomnia,
- •Spiegel scale score is ≥ 18,
- •The informed consent must be obtained from patient
排除标准
- •total sleep time ≤ 2 hours,
- •secondary insomnia,
- •Self-rating Anxiety Scale (SAS) score ≥ 18,
- •Beck Depression Inventory (BDI) score ≥ 6,
- •having hypertension, diabetes, stroke, and coronary heart disease,
- •have drug abuse history,
- •pregnancy or preparing to pregnancy,
- •used immunotherapy or hormone therapy in past 1 years,
- •participating in another clinical trial.
研究组 & 干预措施
Chinese Medicine group
Experimental
Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians
干预措施: Chinese herbal Medicine (Drug)
placebo group
Placebo Comparator
干预措施: the dummy of a Chinese Medicine prescription (Other)
结局指标
主要结局
change from baseline in Total Sleep Time (TST) at 4 weeks
时间窗: baseline and 4 weeks
次要结局
- change from baseline in Chinese Medicine symptoms and signs at 4 weeks(baseline and 4 weeks)
- change from baseline in sleep onset latency at 4 weeks(baseline and 4 weeks)
- change from baseline in wake time after sleep onset at 4 weeks(baseline and 4 weeks)
- change from baseline in sleep efficiency at 4 weeks(baseline and 4 weeks)
- change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks(baseline and 4 weeks)
研究者
Liyun He
Director, Principal Investigator
China Academy of Chinese Medical Sciences
研究点 (1)
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