title: The efficacy and safety of Jian-Wei-Qu-Tong Pills for the treatment of chronic non-atrophic gastritis (spleen and stomach qi deficiency with damp-heat stasis syndrome): study protocol for a phase II, randomized controlled trial.
abstract: BACKGROUND
  Chronic gastritis (CG), a poorly understood entity, is a very common disease of the digestive tract and is difficult to cure. Chronic non-atrophic gastritis (CNG) is the most common type of CG. Even if treated with current standard chemotherapy, some patients will not be freed from this confusing disease. Many studies have shown traditional Chinese medicine (TCM) is more effective compared to chemotherapy in the treatment of chronic gastritis and no serious side effects have been identified. However, the studies that have been carried out were not scientifically rigorous trials. Our aim is to design a high-quality trial for a new TCM drug, the Jian-Wei-Qu-Tong Pills (JWQTP), to investigate the efficacy and safety of this new drug in treating chronic non-atrophic gastritis patients with spleen and stomach qi deficiency with damp-heat stasis syndrome (SSQDDSS).
  
  
  METHODS
  This is a phase II, multicenter, parallel-group, double-blind, randomized and placebo-controlled trial. A total of 240 participants will be assigned to a high-dose group, a low-dose group or a placebo control group with a 1:1:1 ratio at five sites. Then, one dose (six 1-g pills), with a variable ratio between real drug and dummy drug according to the intervention protocol, will be taken three times a day before each meal for 8 weeks. The primary outcome is the eradication rate of epigastric pain. The secondary outcome includes the changes of endoscopic examination, histopathological examination, traditional Chinese medicine symptom scores and patient-reported outcome instrument scores for chronic gastrointestinal diseases and the eradication rate of Helicobacter pylori (HP).
  
  
  CONCLUSIONS
  Many CNG patients suffer from frequent, recurrent bouts of dyspeptic symptoms. This is the first clinical trial to evaluate the safety and efficacy of JWQTP in treating CNG with SSQDDSS in a multicenter, parallel-group, double-blind, randomized and placebo-controlled manner. This trial may not only provide evidence for a phase III clinical trial, but also a vision of an alternative option for CNG treatment.
  
  
  BACKGROUND
  The registration number, ChiCTR-TRC-14004088, was assigned by the Chinese Clinical Trial Registry on 7 January 2014.
authors.forename: Xiao-xin
authors.initials: XX
authors.lastname: Zhang
authors.forename: Wei-wei
authors.initials: WW
authors.lastname: Chen
authors.forename: Bin
authors.initials: B
authors.lastname: She
authors.forename: Rui-jie
authors.initials: RJ
authors.lastname: Luo
authors.forename: Na
authors.initials: N
authors.lastname: Shi
authors.forename: Ping
authors.initials: P
authors.lastname: Xue
authors.forename: Xiao-nan
authors.initials: XN
authors.lastname: Yang
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. xiaqing@medmail.com.cn.
authors.forename: Qing
authors.initials: Q
authors.lastname: Xia
mesh_terms: D000284:Administration, Oral; D002985:Clinical Protocols; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005756:Gastritis / Q000175:diagnosis / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005773:Gastroscopy; D006801:Humans; D008516:Medicine, Chinese Traditional; D008517:Phytotherapy; D010946:Plants, Medicinal; D012107:Research Design; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D005765:Gastrointestinal Agents; D013607:Tablets; C000596349:jian-wei-qu-tong