Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial.
Trials
; 21(1): 568, 2020 Jun 24.
Article
in English
| MEDLINE | ID: covidwho-612407
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 (11) 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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
Drugs, Chinese Herbal
/
Randomized Controlled Trials as Topic
/
Coronavirus Infections
/
Betacoronavirus
/
Medicine, Chinese Traditional
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Traditional medicine
Limits:
Adolescent
/
Adult
/
Aged
/
Humans
/
Middle aged
/
Young adult
Language:
English
Journal:
Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2020
Document Type:
Article
Affiliation country:
S13063-020-04498-6
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