title: Efficacy and safety of the Chaihuguizhiganjiang-suanzaoren granule on primary insomnia: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Insomnia is a highly prevalent, often debilitating and economically burdensome sleep disorder with limited effective therapies. Few data are available to understand which of the therapeutic alternatives is the most effective for patients with insomnia, especially for Traditional Chinese Medicine (TCM). Chinese herbal medicine, as a typical TCM, is one of the most popular complementary and alternative therapies for insomnia. We aim to evaluate the efficacy and safety of the Chaihuguizhiganjiang-suanzaoren granule (CSG), a Chinese herbal medicine treatment, in patients with primary insomnia.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ISRCTN22001145; Pre-results.
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Qing-Quan
authors.initials: QQ
authors.lastname: Liu
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Dongfang Hospital affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
authors.forename: Rong-Juan
authors.initials: RJ
authors.lastname: Guo
authors.affiliation: Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
authors.forename: Ying-Zhen
authors.initials: YZ
authors.lastname: Xie
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Qing-Nan
authors.initials: QN
authors.lastname: Fu
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Tian
authors.initials: T
authors.lastname: He
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Xue-Qi
authors.initials: XQ
authors.lastname: Zhu
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Du
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Yang
authors.affiliation: Dongfang Hospital affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
authors.forename: Jia-Lin
authors.initials: JL
authors.lastname: Wang
authors.affiliation: Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
authors.forename: Min-Min
authors.initials: MM
authors.lastname: Wei
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Qian-Qian
authors.initials: QQ
authors.lastname: Li
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Guang-Xia
authors.initials: GX
authors.lastname: Shi
authors.affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
authors.forename: Cun-Zhi
authors.initials: CZ
authors.lastname: Liu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional / Q000379:methods*; D008875:Middle Aged; D012107:Research Design; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; C018142:saiko-keishi-to; C530157:suanzaoren
keywords: ORAL MEDICINE
references.citation: Arch Intern Med. 2006 Sep 18;166(16):1775-82
references.pmid: 16983058
references.citation: Sleep. 2008 Dec;31(12):1655-62
references.pmid: 19090321
references.citation: Sleep Med Rev. 2015 Dec;24:1-12
references.pmid: 25644982
references.citation: Sleep Med Rev. 2015 Oct;23:54-67
references.pmid: 25645130
references.citation: Sleep. 2004 Dec 15;27(8):1567-96
references.pmid: 15683149
references.citation: Med Care. 1993 Mar;31(3):247-63
references.pmid: 8450681
references.citation: J Clin Epidemiol. 2006 Nov;59(11):1134-49
references.pmid: 17027423
references.citation: Sleep Med Rev. 2012 Dec;16(6):497-507
references.pmid: 22440393
references.citation: Evid Based Complement Alternat Med. 2013;2013:987862
references.pmid: 24204397
references.citation: Behav Sleep Med. 2003;1(4):227-47
references.pmid: 15600216
references.citation: Sleep Med Rev. 2015 Feb;19:17-28
references.pmid: 25104471
references.citation: Evid Based Complement Alternat Med. 2012;2012:409568
references.pmid: 22719784
references.citation: Arch Gen Psychiatry. 1965 Jan;12:63-70
references.pmid: 14221692
references.citation: Menopause. 2012 Aug;19(8):848-55
references.pmid: 22433978
references.citation: Psychosomatics. 1971 Nov-Dec;12(6):371-9
references.pmid: 5172928
references.citation: J Pharmacol Pharmacother. 2010 Jul;1(2):100-7
references.pmid: 21350618
references.citation: BMC Complement Altern Med. 2013;13:18
references.pmid: 23336848
references.citation: Sleep. 2011 May;34(5):601-8
references.pmid: 21532953
references.citation: BMJ. 2013;346:e7586
references.pmid: 23303884