Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial

Trials

Study Protocol

Shuting Sun¹  Yao Qu²  Jinhua Che²  Wen Zhang²  Xinxin Wu²  Bangjiang Fang³  Huacheng Li⁴  Tingrong Huang⁴  You Zheng⁴  Tian Fan⁵  Xiaoming Xu⁶  Shuang Zhou⁷  Chao Jiang⁸  Qin Xie⁹ 

[1] Clinical Medical College of TCM, Hubei University of Chinese Medicine, NO.1 Tanhualin, Wuchang District, 430065, Wuhan, Hubei, China;Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, 725 Wanping South Road, Xuhui District, 200032, Shanghai, NO, China;Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, 725 Wanping South Road, Xuhui District, 200032, Shanghai, NO, China;Clinical Medical College of TCM, Hubei University of Chinese Medicine, NO.1 Tanhualin, Wuchang District, 430065, Wuhan, Hubei, China;Huangshi Hospital of TCM (Infectious Disease Hospital), NO.6 Plaza Road, Huangshi Port District, 435000, Huangshi, Hubei, China;Medical Department of Hubei Minzu University, 445000, Enshi, Hubei, China;Medical Informatics Department, Wuhan Center Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430014, Wuhan, China;Shanghai University of Traditional Chinese Medicine, 1200 Cai Lun Road, Zhangjiang Hi-Tech Park, Pudong New Area, 201203, Shanghai, China;The third Department of Neurology, The Second Affiliated Hospital of Xi’an Medical University, NO.167, Textile City East Street, Baqiao District, 710032, Xi’an, Shanxi, China;Wuhan Mental Health Center, 430012, Wuhan, China;

关键词: COVID-19;    Baidu Jieduan granule;    Efficacy and safety;    Randomized controlled trial;   

DOI  :  10.1186/s13063-021-05418-y

 received in 2020-07-04, accepted in 2021-07-03,  发布年份 2021

来源: Springer

【 摘 要 】

BackgroundCurrently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus far, there is a desperate need to develop effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, with the aim of achieving clinical efficacy and decreasing the use of antibiotics and glucocorticoids. The aim of this study was to evaluate the efficacy and safety of Baidu Jieduan granules in treating COVID-19.Methods/designThis multicentre, open-label, randomized controlled trial will be conducted in 300 patients with COVID-19. The patients will be randomly (1:1) divided into a treatment group and a control group. All patients will receive standard therapy at the same time. Patients in the experimental group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes will be assessed at baseline and at 3, 5, 7 and 14 days after treatment initiation. The primary outcome will be the rate of symptom (fever, fatigue and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.DiscussionThe study will provide high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granules in the treatment of moderate COVID-19, and enrich the theory and practice of TCM in treating COVID-19.Trial registrationChinese Clinical Trial Registry ChiCTR2000029869. Registered on 15 February 2020

【 授权许可】

CC BY   
© The Author(s). 2021

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