title: The efficacy and safety of Baoji Tablets for treating common cold with summer-heat and dampness syndrome: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Despite the high incidence and the economic impact of the common cold, there are still no effective therapeutic options available. Although traditional Chinese medicine (TCM) is widely used in China to treat the common cold, there is still a lack of high-quality clinical trials. This article sets forth the protocol for a high-quality trial of a new TCM drug, Baoji Tablets, which is designed to treat the common cold with summer-heat and dampness syndrome (CCSDS). The trial is evaluating both the efficacy and safety of Baoji Tablets.
  
  
  METHODS
  This study is designed as a multicenter, phase II, parallel-group, double-blind, double-dummy, randomized and placebo-controlled trial. A total of 288 patients will be recruited from four centers. The new tablets group are administered Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. The old pills group are administered dummy Baoji Tablets 0.9 g and Baoji Pills 3.7 g. The placebo control group are administered dummy Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. All drugs are taken three times daily for 3 days. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary and secondary symptoms, changes in primary and secondary symptom scores and cumulative symptom score at day 4, as well as an evaluation of treatment efficacy.
  
  
  CONCLUSIONS
  This is the first multicenter, double-blind, double-dummy, randomized and placebo-controlled trial designated to treat CCSDS in an adult population from China. It will establish the basis for a scientific and objective assessment of the efficacy and safety of Baoji Tablets for treating CCSDS, and provide evidence for a phase III clinical trial.
  
  
  BACKGROUND
  This study is registered with the Chinese Clinical Trial Registry. The registration number is ChiCTR-TRC-13003197.
authors.forename: Rui-zhi
authors.initials: RZ
authors.lastname: Feng
authors.forename: Jian-qin
authors.initials: JQ
authors.lastname: Lv
authors.forename: Angela K
authors.initials: AK
authors.lastname: Johnson
authors.forename: Juan D
authors.initials: JD
authors.lastname: Montoya
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. 123456mike@163.com.
authors.forename: Bing
authors.initials: B
authors.lastname: Mao
mesh_terms: D002985:Clinical Protocols; D003139:Common Cold / Q000188:drug therapy*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008516:Medicine, Chinese Traditional; D017063:Outcome Assessment, Health Care; D018401:Sample Size; D013607:Tablets
chemical_list: D004365:Drugs, Chinese Herbal; D013607:Tablets; C532976:baoji