Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial.
Baidu Jieduan granule
COVID-19
Efficacy and safety
Randomized controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
22 Jul 2021
22 Jul 2021
Historique:
received:
04
07
2020
accepted:
03
07
2021
entrez:
23
7
2021
pubmed:
24
7
2021
medline:
27
7
2021
Statut:
epublish
Résumé
Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus far, there is a desperate need to develop effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, with the aim of achieving clinical efficacy and decreasing the use of antibiotics and glucocorticoids. The aim of this study was to evaluate the efficacy and safety of Baidu Jieduan granules in treating COVID-19. This multicentre, open-label, randomized controlled trial will be conducted in 300 patients with COVID-19. The patients will be randomly (1:1) divided into a treatment group and a control group. All patients will receive standard therapy at the same time. Patients in the experimental group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes will be assessed at baseline and at 3, 5, 7 and 14 days after treatment initiation. The primary outcome will be the rate of symptom (fever, fatigue and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial. The study will provide high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granules in the treatment of moderate COVID-19, and enrich the theory and practice of TCM in treating COVID-19. Chinese Clinical Trial Registry ChiCTR2000029869 . Registered on 15 February 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus far, there is a desperate need to develop effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, with the aim of achieving clinical efficacy and decreasing the use of antibiotics and glucocorticoids. The aim of this study was to evaluate the efficacy and safety of Baidu Jieduan granules in treating COVID-19.
METHODS/DESIGN
METHODS
This multicentre, open-label, randomized controlled trial will be conducted in 300 patients with COVID-19. The patients will be randomly (1:1) divided into a treatment group and a control group. All patients will receive standard therapy at the same time. Patients in the experimental group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes will be assessed at baseline and at 3, 5, 7 and 14 days after treatment initiation. The primary outcome will be the rate of symptom (fever, fatigue and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.
DISCUSSION
CONCLUSIONS
The study will provide high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granules in the treatment of moderate COVID-19, and enrich the theory and practice of TCM in treating COVID-19.
TRIAL REGISTRATION
BACKGROUND
Chinese Clinical Trial Registry ChiCTR2000029869 . Registered on 15 February 2020.
Identifiants
pubmed: 34294144
doi: 10.1186/s13063-021-05418-y
pii: 10.1186/s13063-021-05418-y
pmc: PMC8295640
doi:
Substances chimiques
Antiviral Agents
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
476Subventions
Organisme : National Key Research and Development Program of China
ID : 2018YFC1705900
Organisme : Emergency Committee of the World Federation of Chinese Medicine Societies and Shanghai Society of Traditional Chinese Medicine, Novel Coronavirus Pneumonia Emergency Tackling Key Project
ID : SJZLJZ.N01
Informations de copyright
© 2021. The Author(s).
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