title: Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Although the common cold is generally mild and self-limiting, it is a leading cause of consultations with doctors and missed days from school and work. In light of its favorable effects of relieving symptoms and minimal side-effects, Traditional Chinese Medicine (TCM) has been widely used to treat the common cold. However, there is a lack of robust evidence to support the clinical utility of such a treatment. This study is designed to evaluate the efficacy and safety of Gantong Granules compared with placebo in patients with the common cold with wind-heat syndrome (CCWHS).
  
  
  METHODS
  This is a multicenter, phase IIb, double-blind, placebo-controlled and randomized clinical trial. A total of 240 patients will be recruited, from 5 centers across China and randomly assigned to the high-dose group, medium-dose group, low-dose group or placebo control group in a 1:1:1:1 ratio. All subjects will receive the treatment for 3 to 5 days, followed by a 7-day follow-up period. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score.
  
  
  CONCLUSIONS
  This trial will provide high-quality evidence on the efficacy and safety of Gantong Granules in treating CCWHS, and help to optimize the dose selection for a phase III clinical trial.
  
  
  BACKGROUND
  The registration number is ChiCTR-TRC-14004255 , which was assigned by the Chinese Clinical Trial Registry on 12 February 2014.
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. jane_min51@hotmail.com.
authors.forename: Jie
authors.initials: J
authors.lastname: Min
authors.affiliation: Anesthesia Department, West China Hospital of Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, People's Republic of China. 39006900@qq.com.
authors.forename: Xiao-qiang
authors.initials: XQ
authors.lastname: Li
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. she-bin@163.com.
authors.forename: Bin
authors.initials: B
authors.lastname: She
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. 470800112@qq.com.
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. maobing@medmail.com.cn.
authors.forename: Bing
authors.initials: B
authors.lastname: Mao
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001833:Body Temperature Regulation / Q000187:drug effects; D002681:China; D002985:Clinical Protocols; D003139:Common Cold / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000821:virology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005334:Fever / Q000188:drug therapy / Q000503:physiopathology / Q000821:virology; D006801:Humans; D012074:Remission Induction; D012107:Research Design; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004365:Drugs, Chinese Herbal; C000604617:gantong