Abstract
BackgroundDespite 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/designThis 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.DiscussionThis 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 registrationThis study is registered with the Chinese Clinical Trial Registry. The registration number is ChiCTR-TRC-13003197.
Highlights
Despite the high incidence and the economic impact of the common cold, there are still no effective therapeutic options available
The common cold is the conventional term used to describe a mild, self-limited, viral, upper respiratory tract infection and it is the most prevalent disease experienced by humans [1]
The common cold with summer-heat and dampness syndrome (CCSDS) is most commonly seen in midsummer and it is primarily characterized by aversion to cold, fever, diarrhea, nausea and vomiting
Summary
There are still no effective therapeutic options available to treat the common cold. A number of high-quality clinical trials are needed before any Chinese herbal preparation can be recommended for the common cold [21]. For this reason, the study protocol was designed according to the Consolidated Standards of Reporting Trials statement [22]. Previous studies have only focused on wind-cold syndrome and wind-heat syndrome This will be the first multicenter, double-blind, double-dummy, randomized and placebocontrolled trial designed to treat CCSDS in an adult population from China. All authors critically reviewed the content and approved the final version
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