NCT02594670Unknown不适用
Acupuncture Based on Different Acupoints Combination for Insomnia: a Randomized Controlled Trial
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine3 个研究点 分布在 1 个国家目标入组 333 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 333
- 试验地点
- 3
- 主要终点
- Pittsburgh sleep quality index (PSQI)
研究概览
简要总结
Selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. Different combinations of acupoints will generate different clinical efficacy. So,the purpose of this study is to determine the different clinical efficacy among three types of combinations of acupoints in the treatment of primary insomnia.
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
- Double (Participant, Outcomes Assessor)
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
- •Diagnosed as insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,2013, American psychiatric association
- •PSQI score >7
- •AIS score ≥6
- •Age between 18 and 65 years old
- •Not involved in other clinical trial in the lasted 6 months before screening
- •Have the ability to write the informed consent.
排除标准
- •Breathing-related sleep disorders
- •Circadian rhythm sleep-wake disorders
- •Medication-induced sleep disorder
- •Substance induced sleep disorders,such as alcohol, coffee, strong tea
- •Secondary insomnia caused by systemic diseases or caused by external environment disturbance
- •Pregnant or lactating women
- •Combined with serious cardiovascular, lung, liver, kidney, hematopoietic system, and mental diseases
- •Advanced malignant tumor or other serious debilitating diseases
- •Location of acupoints combined with infection and bleeding
- •Declined to acupuncture
- •Couldn't provide the written informed consent.
结局指标
主要结局
Pittsburgh sleep quality index (PSQI)
时间窗: 4 weeks
次要结局
- Short Form 36-item Health Survey(SF-36)(4 weeks and 8 weeks)
- Athens Insomnia Scale (AIS)(4 weeks and 8 weeks)
- Self-anxiety scale (SAS)(4 weeks and 8 weeks)
- Self-depression scale (SDS)(4 weeks and 8 weeks)
研究者
研究点 (3)
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