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

Trials

Bing Mao³  Juan D Montoya²  Angela K Johnson¹  Jian-qin Lv³  Rui-zhi Feng³ 

[1] Department of Emergency Medicine, Carolinas Medical Center, 1000 Blythe Blvd, Charlotte, NC 28203, USA;Department of Emergency Medicine, University of North Carolina Hospitals, 170 Manning Drive, Chapel Hill, NC 27514, USA;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

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

Others  :  807772
DOI  :  10.1186/1745-6215-14-440

 received in 2013-09-01, accepted in 2013-12-05,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Feng et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]Herlov-Nielsen H, Permin H: Common cold–risk factors, transmission and treatment. Ugeskr Laeger 2001, 163:5643-5646.
• [2]Arroll B: Common cold. Am Fam Physician 2011, 84:1390-1391.
• [3]Worrall G: Common cold. Can Fam Physician 2011, 57:1289-1290.
• [4]Turner RB: The common cold. In Goldman's Cecil Medicine. 24th edition. Edited by Goldman L, Schafer AI. Philadelphia: Saunders Elsevier; 2011:2089-2090.
• [5]Treanor JJ: Adenovirus Diseases. In Goldman's Cecil Medicine. 24th edition. Edited by Goldman L, Schafer AI. Philadelphia: Saunders Elsevier; 2011:2100-2101.
• [6]Romero JR: Enteroviruses. In Goldman's Cecil Medicine. 24th edition. Edited by Goldman L, Schafer AI. Philadelphia: Saunders Elsevier; 2011:2140-2143.
• [7]Woodwell DA, Cherry DK: National Ambulatory Medical Care Survey: 2002 summary. Adv Data 2004, 346:1-44.
• [8]McCaig LF, Burt CW: National hospital ambulatory medical care survey: emergency department summary. Adv Data 2004, 2002:1-34.
• [9]Fendrick AM, Monto AS, Nightengale B, Sarnes M: The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med 2003, 163:487-494.
• [10]Simasek M, Blandino DA: Treatment of the common cold. Am Fam Physician 2007, 75:515-520.
• [11]Commission SP: Pharmacopoeia of the People's Republic of China. 9th edition. Beijing: China Medical Science Press; 2010.
• [12]Vijayananthan A, Nawawi O: The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J 2008, 4:e5.
• [13]Jackson GG, Dowling HF, Muldoon RL: Acute respiratory diseases of viral etiology. VII. Present concepts of the common cold. Am J Public Health Nations Health 1962, 52:940-945.
• [14]Zhen XY: Guidelines for Clinical Research of New Chinese Medicine. Beijing: China Medical Science Press; 2002.
• [15]Audera C, Patulny RV, Sander BH, Douglas RM: Mega-dose vitamin C in treatment of the common cold: a randomised controlled trial. Med J Aust 2001, 175:359-362.
• [16]Wang L, Zhang RM, Liu GY, Wei BL, Wang Y, Cai HY, Li FS, Xu YL, Zheng SP, Wang G: Chinese herbs in treatment of influenza: a randomized, double-blind, placebo-controlled trial. Respir Med 2010, 104:1362-1369.
• [17]Wong W, Lam CL, Fong DY: Treatment effectiveness of two Chinese herbal medicine formulae in upper respiratory tract infections – a randomized double-blind placebo-controlled trial. Fam Pract 2012, 29:643-652.
• [18]Chang J, Zhang Y, Mao B, Wang L, Li TQ, Zhang RM: A double-blind, randomized controlled trial of Chaige Qingre Granule in treating acute upper respiratory tract infection of wind heat syndrome. Zhong Xi Yi Jie He Xue Bao 2007, 5:141-146.
• [19]Chang J, Dong SJ, She B, Zhang RM, Meng MB, Xu YL, Wan LL, Shi KH, Pan JH, Mao B: Treatment of common cold patients with the shi-cha capsule: a multicenter, double-blind, randomized, placebo-controlled, dose-escalation trial. Evid Based Complement Alternat Med 2012, 2012:254571.
• [20]Zhong YQ, Fu JJ, Liu XM, Diao X, Mao B, Fan T, Yang HM, Liu GJ, Zhang WB: The reporting quality, scientific rigor, and ethics of randomized placebo-controlled trials of traditional Chinese medicine compound formulations and the differences between Chinese and non-Chinese trials. Curr Ther Res Clin E 2010, 71:30-49.
• [21]Wu T, Zhang J, Qiu Y, Xie L, Liu GJ: Chinese medicinal herbs for the common cold. Cochrane Database Systematic Reviews 2007., 1CD004782
• [22]Moher D, Schulz KF, Altman D: The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY) 2005, 1:40-45.