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Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label
Bangjiang Fang1,2, Wen Zhang1, Xinxin Wu1
1Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.
Insights
This study evaluates Shenhuang granule for severe COVID-19 patients. It
Area of Science:
- Integrative and Complementary Medicine
- Infectious Diseases
- Critical Care Medicine
Background:
- Severe coronavirus disease 2019 (COVID-19) poses a significant global health threat.
- No definitive antiviral treatments are currently established for COVID-19.
- Traditional Chinese Medicine (TCM) offers potential therapeutic options for infectious diseases, aiming to reduce antibiotic and glucocorticoid use.
Purpose of the Study:
- To assess the efficacy and safety of Shenhuang granule in treating severe COVID-19.
- To provide evidence-based recommendations for TCM in managing severe COVID-19.
- To contribute to the theoretical and practical understanding of TCM for infectious diseases.
Main Methods:
- A multicenter, open-label randomized controlled trial involving 160 severe COVID-19 participants.
- Participants randomly assigned (1:1) to receive standard therapy plus Shenhuang granule or standard therapy alone for 14 days.
- Clinical indicators and adverse events monitored at baseline and days 3, 5, 7, and 14; primary outcome is 14-day clinical outcome.
Main Results:
- Data collection and analysis are ongoing.
- Results will determine the clinical effectiveness of Shenhuang granule.
- Safety profile and adverse events will be thoroughly documented.
Conclusions:
- This trial represents the first randomized controlled evaluation of Shenhuang granule for severe COVID-19 in China.
- Findings may inform clinical practice and advance TCM's role in infectious disease management.
- The study aims to enrich TCM theory and application in treating critical infectious conditions.
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.
