ISRCTN16079489已完成未知
Acupuncture for treatment of primary insomnia: a randomized, single-blinded, sham-controlled trial
Beijing Scientific Committee0 个研究点目标入组 88 人开始时间: 2015年4月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 88
研究概览
简要总结
2016 protocol in https://pubmed.ncbi.nlm.nih.gov/26956161/ (added 17/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Meeting the primary insomnia criteria of DSM-IV-TR
- •2. Patients with insomnia persistent for 3 months or longer before the start of the observation period
- •3. Score of 8 or above on the PSQI, 33 or above on the HAS
- •4. Having not yet received any psychoactive medications
- •5. No problem with communication and intelligence
- •6. Either gender aged 18-65 years
- •7. Signed the written informed consent form for the clinical trial
排除标准
- •1. Patients who had epilepsy, diabetes mellitus, cardiovascular disease, kidney failure, hypertension, metabolic diseases, benign prostatic hyperplasia
- •2. Patients who had depression, anxiety ,schizophrenia and other severe mental disorders
- •3. Patients who had other sleep disorders, or discovered any other sleep disorder on PSG at the baseline, like sleep apnea, restless legs syndrome
- •4. Pregnancy, breastfeeding, or woman of childbearing age not on a proper method of birth control
- •5. Patients who had acupuncture for insomnia treatment in the past month
- •6. Patients who had taken alcohol and/or mentally active drug, drug abuse and dependence
- •7. Patients who fear or can’t accept the acupuncture therapy
研究者
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