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Open Access 01-12-2020 | COVID-19 | Study protocol

Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

Authors: Bangjiang Fang, Wen Zhang, Xinxin Wu, Tingrong Huang, Huacheng Li, You Zheng, Jinhua Che, Shuting Sun, Chao Jiang, Shuang Zhou, Jun Feng

Published in: Trials | Issue 1/2020

Abstract

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.

Trial registration

Chinese Clinical Trial Registry, ChiCTR2000029777. Registered on 13 February 2020.

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Title: Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial
Authors: Bangjiang Fang
Wen Zhang
Xinxin Wu
Tingrong Huang
Huacheng Li
You Zheng
Jinhua Che
Shuting Sun
Chao Jiang
Shuang Zhou
Jun Feng
Publication date: 01-12-2020
Publisher: BioMed Central
Keyword: COVID-19
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04498-6

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Methods/design

Discussion

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