Abstract | INTRODUCTION: METHODS AND ANALYSIS: This is a multicentre, placebo-controlled, double-blinded, randomised controlled clinical trial. A total of 258 participants are randomly allocated to two groups: the intervention group or the placebo group. The intervention group receives CSG and the placebo group receives a placebo granule. The patients receive either CSG or placebo two times daily for 8 weeks. The primary outcome is the Pittsburgh sleep quality index (PSQI). Secondary outcomes include the Insomnia Severity Index (ISI), Total Sleep Time (TST) and the Short-Form Health Survey (SF-36). The assessment is performed at baseline (before randomisation), 4, 8 and 12 weeks after randomisation. ETHICS AND DISSEMINATION: The protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (reference: 2014BL-003-01). The trial will be helpful in identifying the efficacy and safety of CSG in patients with primary insomnia. TRIAL REGISTRATION NUMBER: ISRCTN22001145; Pre-results.
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Authors | Qing-Quan Liu, Jie Zhang, Rong-Juan Guo, Ying-Zhen Xie, Qing-Nan Fu, Tian He, Xue-Qi Zhu, Jie Du, Jing Yang, Jia-Lin Wang, Min-Min Wei, Qian-Qian Li, Guang-Xia Shi, Cun-Zhi Liu |
Journal | BMJ open
(BMJ Open)
Vol. 6
Issue 2
Pg. e008459
(Feb 02 2016)
ISSN: 2044-6055 [Electronic] England |
PMID | 26839010
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ |
Chemical References |
- Drugs, Chinese Herbal
- saiko-keishi-to
- suanzaoren
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Topics |
- Adolescent
- Adult
- Aged
- Double-Blind Method
- Drugs, Chinese Herbal
(adverse effects, therapeutic use)
- Female
- Humans
- Male
- Medicine, Chinese Traditional
(methods)
- Middle Aged
- Research Design
- Sleep Initiation and Maintenance Disorders
(drug therapy)
- Treatment Outcome
- Young Adult
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