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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/design  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.    Discussion  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.    Trial registration  This study is registered with the Chinese Clinical Trial Registry. The registration number is  ChiCTR-TRC-13003197 .

trials

The efficacy and safety of Baoji Tablets for treating common cold with summer-heat and dampness syndrome: study protocol for a randomized controlled trial