Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.
Clinical Medical College of TCM, Hubei University of Chinese Medicine, NO.1 Tanhualin, Wuchang District, Wuhan, 430065, Hubei, China.
Trials. 2020 Jun 24;21(1):568. doi: 10.1186/s13063-020-04498-6.
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.
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.
Chinese Clinical Trial Registry, ChiCTR2000029777. Registered on 13 February 2020.
目前，2019 年冠状病毒病（COVID-19）持续快速传播，对公众健康造成严重损害。到目前为止，还没有有效的抗病毒治疗方法。中药（TCM）在中国已广泛应用于多种感染性疾病的治疗，希望能产生临床效果，减少抗生素和糖皮质激素的使用。本研究旨在评估参黄颗粒治疗重症 COVID-19 的疗效和安全性。
方法/设计：这是一项多中心、开放性、随机对照临床试验，共纳入 160 例重症 COVID-19 患者。将患者随机（1:1）分为治疗组或对照组。所有患者同时给予标准治疗。实验组接受参黄颗粒治疗，每天两次，疗程 14 天。在治疗开始后第 3、5、7 和 14 天评估患者的临床指标。主要结局是 14 天临床结局。整个试验过程中监测不良反应。
这将是第一项评估参黄颗粒治疗中国重症 COVID-19 患者的疗效的随机对照临床试验。该试验结果不仅可为临床医生治疗重症 COVID-19 提供循证建议，还将丰富 TCM 治疗传染病的理论和实践。
中国临床试验注册中心，ChiCTR2000029777。注册于 2020 年 2 月 13 日。
