Chinese herbal medicine Shufeng Jiedu capsule for mild to moderate COVID-19: a multicenter, randomized, double-blind, placebo-controlled phase II trial.

Autor:	Lu CL; Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China., Yang LQ; The Third People's Hospital of Shenzhen, The Second Affiliated Hospital to Southern University of Science and Technology, Shenzhen, China., Jin XY; Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China., Friedemann T; HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center, Hamburg, Germany., Li YF; Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China., Liu XH; Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China., Chen XY; Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China., Zou XY; Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China., Zhang BR; Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China., Wang FX; The Third People's Hospital of Shenzhen, The Second Affiliated Hospital to Southern University of Science and Technology, Shenzhen, China., Lin YL; The Third People's Hospital of Shenzhen, The Second Affiliated Hospital to Southern University of Science and Technology, Shenzhen, China., Tang YM; The Third People's Hospital of Shenzhen, The Second Affiliated Hospital to Southern University of Science and Technology, Shenzhen, China., Cao ML; The Third People's Hospital of Shenzhen, The Second Affiliated Hospital to Southern University of Science and Technology, Shenzhen, China., Jiang YL; The People's Hospital of Bozhou, Bozhou, China., Gao YF; The People's Hospital of Bozhou, Bozhou, China., Liu K; The People's Hospital of Bozhou, Bozhou, China., Tao ZG; Zhongshan Hospital Affiliated of Fudan University, Shanghai, China., Robinson N; Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.; Institute of Health and Social Care, London South Bank University, London, United Kingdom., Schröder S; HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center, Hamburg, Germany., Liu JP; Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China., Lu HZ; The Third People's Hospital of Shenzhen, The Second Affiliated Hospital to Southern University of Science and Technology, Shenzhen, China.
Jazyk:	angličtina
Zdroj:	Frontiers in pharmacology [Front Pharmacol] 2024 May 27; Vol. 15, pp. 1383831. Date of Electronic Publication: 2024 May 27 (Print Publication: 2024).
DOI:	10.3389/fphar.2024.1383831
Abstrakt:	Background: The COVID-19 pandemic has had a profound global impact, although the majority of recently infected cases have presented with mild to moderate symptoms. Previous clinical studies have demonstrated that Shufeng Jiedu (SFJD) capsule, a Chinese herbal patent medicine, effectively alleviates symptoms associated with the common cold, H1N1 influenza, and COVID-19. This study aimed to assess the efficacy and safety of SFJD capsules in managing symptoms of mild to moderate COVID-19 infection. Methods: A randomized, double-blind, placebo-controlled trial was conducted from May to December 2022 at two hospitals in China. Mild and moderate COVID-19-infected patients presenting respiratory symptoms within 3 days from onset were randomly assigned to either the SFJD or placebo groups in a 1:1 ratio. Individuals received SFJD capsules or a placebo three times daily for five consecutive days. Participants were followed up for more than 14 days after their RT-PCR nucleoid acid test for SARS-CoV-2 turned negative. The primary outcome measure was time to alleviate COVID-19 symptoms from baseline until the end of follow-up. Results: A total of 478 participants were screened; ultimately, 407 completed the trial after randomization (SFJD, n = 203; placebo, n = 204). No statistically significant difference in baseline parameters was observed between the two groups. The median time to alleviate all symptoms was 7 days in the SFJD group compared to 8 days in the placebo group ( p = 0.037). Notably, the SFJD group significantly attenuated fever/chills ( p = 0.04) and headache ( p = 0.016) compared to the placebo group. Furthermore, the median time taken to reach normal body temperature within 24 h was reduced by 7 hours in the SFJD group compared to the placebo group ( p = 0.033). No deaths or instances of serious or critical conditions occurred during this trial period; moreover, no serious adverse events were reported. Conclusion: The trial was conducted in a unique controlled hospital setting, and the 5-day treatment with SFJD capsules resulted in a 1-day reduction in overall symptoms, particularly headache and fever/chills, among COVID-19-infected participants with mild or moderate symptoms. Compared to placebo, SFJD capsules were found to be safe with fewer side effects. SFJD capsules could potentially serve as an effective treatment for alleviating mild to moderate symptoms of COVID-19. Clinical Trial Registration : https://www.isrctn.com/, identifier ISRCTN14236594. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2024 Lu, Yang, Jin, Friedemann, Li, Liu, Chen, Zou, Zhang, Wang, Lin, Tang, Cao, Jiang, Gao, Liu, Tao, Robinson, Schröder, Liu and Lu.)
Databáze:	MEDLINE
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