Email updates

Keep up to date with the latest news and content from Trials and BioMed Central.

Open Access Study protocol

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

Rui-zhi Feng1, Jian-qin Lv1, Angela K Johnson2, Juan D Montoya3 and Bing Mao1*

Author Affiliations

1 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

2 Department of Emergency Medicine, Carolinas Medical Center, 1000 Blythe Blvd, Charlotte, NC 28203, USA

3 Department of Emergency Medicine, University of North Carolina Hospitals, 170 Manning Drive, Chapel Hill, NC 27514, USA

For all author emails, please log on.

Trials 2013, 14:440  doi:10.1186/1745-6215-14-440

Published: 21 December 2013

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/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.

Keywords:
Common cold; Summer-heat and dampness syndrome; Baoji Tablets; Traditional Chinese medicine; Randomized controlled trial