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临床试验/ISRCTN16079489
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

发起方
Beijing Scientific Committee

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