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

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

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial
Creator	Zhang, Wen Jiang, Chao Feng, Jun Che, Jinhua Fang, Bangjiang Huang, Tingrong Li, Huacheng Sun, Shuting Wu, Xinxin Zhou, Shuang Zheng, You
source	Medline; PMC
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.
has issue date	2020-06-24(xsd:dateTime)
bibo:doi	10.1186/s13063-020-04498-6
bibo:pmid	32580752
has license	cc-by
sha1sum (hex)	f4f43c297ced39c4e6ecba260f48543d4da63c57
schema:url	https://doi.org/10.1186/s13063-020-04498-6
resource representing a document's title	Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial
has PubMed Central identifier	PMC7312108
has PubMed identifier	32580752
schema:publication	Trials
resource representing a document's body	covid:f4f43c297ced39c4e6ecba260f48543d4da63c57#body_text
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