title: Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Irritable bowel syndrome (IBS) is a common gastrointestinal functional disorder with no effective therapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies in China. We designed this study to evaluate the efficacy and safety of Shun-Qi-Tong-Xie Granule (SQTX Granule), a TCM treatment, in patients with IBS with diarrhea (IBS-D).
  
  
  METHODS
  A randomised, double-blinded, placebo-controlled, multi-centre, superiority clinical trial to evaluate the efficacy and safety of SQTX Granule is proposed. Eligible patients (Rome III) with IBD-S will be randomly assigned into SQTX Granule group and the placebo group. Patients will receive a 28-day treatment and a 2-month follow-up. The primary outcome measures include the scores of IBS-quality of life (IBS-QOL) rating scale and IBS-symptom severity scale (IBS-SSS) rating scale. The secondary outcome measures include the improvement of symptom scores, and the duration of abdominal pain and diarrhea.
  
  
  CONCLUSIONS
  According to TCM theory, SQTX Granule has a regulating effect on abdominal pain, diarrhea and the syndrome of liver-spleen disharmony, which is similar to the symptoms of IBS-D. This study will provide objective evidence to evaluate the efficiency and safety of SQTX Granule in IBS-D treatment.
  
  
  BACKGROUND
  ChiCTR-TRC-14004241. Date of registration: 9 February 2014.
authors.forename: Xiao-xiang
authors.initials: XX
authors.lastname: Wang
authors.forename: Rui-jie
authors.initials: RJ
authors.lastname: Luo
authors.forename: Bin
authors.initials: B
authors.lastname: She
authors.forename: Yan
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Integrated Traditional and Western Medicine, West China Hospital of Sichuan University, 37 Guoxue Lane, Chengdu 610041, Sichuan Province, People's Republic of China. jiajia818@163.com.
authors.forename: Jia
authors.initials: J
authors.lastname: Guo
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy / Q000209:etiology; D000284:Administration, Oral; D002985:Clinical Protocols; D003967:Diarrhea / Q000188:drug therapy / Q000209:etiology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D008516:Medicine, Chinese Traditional; D008517:Phytotherapy; D010946:Plants, Medicinal; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; C000596350:shun-qi-tong-xie