Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial
Background: Currently, coronavirus disease 2019 (COVID-19) is continuously and rapidly circulating, causing heavy damage on public health. No effective antiviral treatment has been proved thus far. Traditional Chinese medicine (TCM) has been widely applied in the treatment of a variety of infection diseases in China, hoping to produce clinical effects and reduce the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Shenhuang granule in treatment of severe COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted in 160 participants with severe COVID-19. The participants will be randomly (1:1) divided into treatment group or control group. All participants are given standard therapy at the same time. The experiment will receive Shenhuang granule treatment twice a day for 14 days. The clinical indicators of patients will be assessed at baseline and at 3, 5, 7, and 14 days after treatment initiation. The primary outcome is 14-day clinical outcome. Adverse events will be monitored throughout the trial. Discussion: This will be the first randomized controlled trial, which evaluate the effect of Shenhuang granule in patients with severe COVID-19 in China. The results of this trial may not only provide evidence-based recommendations to clinicians to treat severe COVID-19, but also enrich the theory and practice of TCM in treating infectious diseases.
基金：
Emergency Committee of the World Federation of Chinese Medicine Societies; Shanghai Society of Traditional Chinese Medicine, Novel Coronavirus Pneumonia Emergency Tackling Key Project [SJZLJZ.N01]; National Key Research and Development Program of China [2018YFC1705900]
第一作者单位：[1]Shanghai Univ Tradit Chinese Med, LongHua Hosp, Dept Emergency, 725 Wanping South Rd, Shanghai 200032, Peoples R China[2]Hubei Univ Chinese Med, Clin Med Coll TCM, 1 Tanhualin, Wuhan 430065, Hubei, Peoples R China
通讯作者：
推荐引用方式(GB/T 7714)：
Fang Bangjiang,Zhang Wen,Wu Xinxin,et al.Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial[J].TRIALS.2020,21(1):doi:10.1186/s13063-020-04498-6.
APA：
Fang, Bangjiang,Zhang, Wen,Wu, Xinxin,Huang, Tingrong,Li, Huacheng...&Feng, Jun.(2020).Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial.TRIALS,21,(1)
MLA：
Fang, Bangjiang,et al."Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial".TRIALS 21..1(2020)
