Abstract
BackgroundCurrently, 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/designThis 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.DiscussionThis 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 registrationChinese Clinical Trial Registry, ChiCTR2000029777. Registered on 13 February 2020.
Highlights
In December 2019, an outbreak of unexplained pneumonia has been diagnosed in Wuhan, Hubei Province, in China, with an epidemiological link to seafood and wet animal wholesale market where there was sale of live animals [1, 2]
This will be the first randomized controlled trial, which evaluate the effect of Shenhuang granule in patients with severe COVID-19 in China
On the foundation of the above theories, we developed the Shenhuang granule, a formula which is composed of six medicinal herbs, including Panax ginseng (Renshen), Rheum palmatum L. stem (Dahuang), Sargentodoxa cuneate (Hongteng), Taraxacum mongolicum (Pugongying), Aconiti Lateralis Radix Praeparata (Fuzi), and Whitmania pigra Whitman (Shuizhi)
Summary
In December 2019, an outbreak of unexplained pneumonia has been diagnosed in Wuhan, Hubei Province, in China, with an epidemiological link to seafood and wet animal wholesale market where there was sale of live animals [1, 2]. The Chinese scientists isolated an unknown coronavirus from the patient’s respiratory epithelial cells of patients and performed genome sequencing of the virus [3]. This new virus is named “severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2),” and it causes “coronavirus disease 2019 (COVID-19).”. COVID-19 is considered to be the origin of zoonotic diseases, human-to human transmission has been occurred [4] It initially erupted in Wuhan and later spread to all parts of the world, resulting in 2,954,222 confirmed cases, including 202,597 deaths globally as 28 April 2020, which caused a global health emergency [5]. The aim of this study is to evaluate the efficacy and safety of Shenhuang granule in treatment of severe COVID-19
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