Phytomedicine : international journal of phytotherapy and phytopharmacology · 2025
Fuzheng Jiedu granules for high-risk adults with COVID-19: A randomized, double-blind, placebo-controlled, multi-centre trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Shui Jingwei, Xu Xiaohua, Liu Yuntao, Hua Qiaoli, Cai Yihang, Zheng Danwen, Huang Fuqiang, Gao Lili, Li Jiqiang, Wen Zehuai, Li Geng, Zhang Erli, Xu Yawen, Chen Handong, Yan Chunjiang, Yang Rongyuan, Guo Jianwen, Zhang Zhongde
Аннотация
BACKGROUND: Fuzheng Jiedu granules (FZJD) is widely used for COVID-19 in China, with early studies indicating reduced mortality in severe cases. However, with emerging variants and shifted treatment focus on preventing severity and relieving symptoms, high-level clinical evidence, especially for high-risk patients, remains lacking.
METHODS: A randomized controlled trial (ChiCTR2200058181 ) was performed to assess FZJD's efficacy and safety in high-risk adults with non-severe COVID-19. The primary outcome was the proportion of progression to severe COVID-19 after enrollment, with secondary outcomes focusing on the time to resolution of main symptoms.
RESULTS: From November 2021 to July 2022, 231 eligible patients were randomized to receive either 15 g of FZJD (n = 119) or placebo (n = 112) thrice daily for 14 days. Patients receiving FZJD (1/101, 1.0 % [95 % CI, 0.0 %, 5.4 %]) had a numerically lower progression proportion to severe COVID-19 than those receiving placebo (2/95, 2.1 % [95 % CI, 0.3 %, 7.4 %]), although with a non-significant difference of -1.1 % (95 % CI, -7.4 %, 6.2 %; p = 0.545) after adjusted by center. FZJD use was associated with significantly shorter time to sustained disappearance of cough (median days, 10.0 vs. 12.0, HR, 1.46 [1.03, 2.07], p = 0.022), fever (median days, 6.0 vs. 7.0, HR, 1.69 [1.03, 2.76], p = 0.031), and chest distress (median days, 7.0 vs. 11.0, HR, 3.28 [1.23, 8.73], p = 0.031). Patients experience comparable adverse events in the two groups (2.7 % in FZJD vs. 1.9 % in placebo).
CONCLUSION: Among high-risk COVID-19 patients, FZJD showed obvious symptom improvements and numerically lower disease progression than placebo, without additional adverse events.
METHODS: A randomized controlled trial (ChiCTR2200058181 ) was performed to assess FZJD's efficacy and safety in high-risk adults with non-severe COVID-19. The primary outcome was the proportion of progression to severe COVID-19 after enrollment, with secondary outcomes focusing on the time to resolution of main symptoms.
RESULTS: From November 2021 to July 2022, 231 eligible patients were randomized to receive either 15 g of FZJD (n = 119) or placebo (n = 112) thrice daily for 14 days. Patients receiving FZJD (1/101, 1.0 % [95 % CI, 0.0 %, 5.4 %]) had a numerically lower progression proportion to severe COVID-19 than those receiving placebo (2/95, 2.1 % [95 % CI, 0.3 %, 7.4 %]), although with a non-significant difference of -1.1 % (95 % CI, -7.4 %, 6.2 %; p = 0.545) after adjusted by center. FZJD use was associated with significantly shorter time to sustained disappearance of cough (median days, 10.0 vs. 12.0, HR, 1.46 [1.03, 2.07], p = 0.022), fever (median days, 6.0 vs. 7.0, HR, 1.69 [1.03, 2.76], p = 0.031), and chest distress (median days, 7.0 vs. 11.0, HR, 3.28 [1.23, 8.73], p = 0.031). Patients experience comparable adverse events in the two groups (2.7 % in FZJD vs. 1.9 % in placebo).
CONCLUSION: Among high-risk COVID-19 patients, FZJD showed obvious symptom improvements and numerically lower disease progression than placebo, without additional adverse events.