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.

2021-07-22
Trials 22(1)
- Wen Zhang
- Qin Xie
- Xiaoming Xu
- Shuting Sun
- Tian Fan
- Xinxin Wu
- Yao Qu
- Jinhua Che
- Tingrong Huang
- Huacheng Li
- You Zheng
- Chao Jiang
- Bangjiang Fang
- Shuang Zhou

PubMed: 34294144
DOI: 10.1186/s13063-021-05418-y

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 300
Population: 300 patients with COVID-19
Methods: Multicentre, open-label, randomized controlled trial; 300 patients randomly (1:1) divided into treatment and control groups; all receive standard therapy; experimental group receives Baidu Jieduan granule twice daily for 14 days
Blinding: Open-label
Duration: 14 days
Funding: Unclear

Large Human Trial

Background

Currently, 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/design

This 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.

Discussion

The 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 registration

Chinese Clinical Trial Registry ChiCTR2000029869 . Registered on 15 February 2020.