JMIR research protocols · 2026
Efficacy and Safety of Kanggan Mixture for Influenza: Protocol for a Multicenter Open-Label Randomized Controlled Trial.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Gao Yilan, Ge Yue, Wang Qian, Sun Zibo, Dong Shuo, Tang Yanfen, Zhang Guicai, Zhou Xianmei, He Hailang
Аннотация
BACKGROUND: Influenza, a highly contagious acute respiratory illness, causes annual seasonal epidemics worldwide, imposing a substantial public health burden. Although neuraminidase inhibitors, such as oseltamivir, can shorten symptom duration, their use is limited by antiviral resistance and adverse reactions. Kanggan mixture (KGM), an in-hospital traditional Chinese medicine preparation at Jiangsu Province Hospital of Chinese Medicine, has been widely used in clinical practice for influenza treatment, showing favorable effects on fever reduction and symptom improvement; however, high-quality comparative evidence on the efficacy and safety of KGM remains limited. This study is designed to address this gap by evaluating whether KGM is noninferior to oseltamivir for the treatment of influenza.
OBJECTIVE: This study aims to determine whether KGM is noninferior to oseltamivir in improving the clinical outcomes in patients with influenza and to assess the safety profile of KGM.
METHODS: This study is a multicenter, open-label, randomized controlled trial to be conducted in 3 tertiary grade A hospitals in China. Eligible participants with influenza will be randomly assigned in a 1:1 ratio to receive either KGM or oseltamivir for 5 days. A total of 184 participants will be enrolled, with 92 (50%) participants in each group. The primary outcome is time to clinical alleviation. Secondary outcomes include time to defervescence, time to onset of antipyretic effect, individual influenza symptom scores, and total influenza symptom scores. Adverse events will be monitored throughout the trial to evaluate the safety of KGM.
RESULTS: This study was funded in July 2024. Recruitment began in September 2025 and is expected to be completed in June 2026. The study results are expected to be published by December 2026.
CONCLUSIONS: This protocol describes a multicenter randomized controlled trial designed to generate comparative evidence on the efficacy and safety of KGM for influenza treatment. The findings of this study are expected to provide initial clinical evidence supporting the use of KGM in the treatment of influenza, clarify its therapeutic value as a potential alternative to oseltamivir, and offer a novel alternative strategy for influenza management while contributing to the evidence base for integrating traditional Chinese medicine into influenza care.
TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry ITMCTR2025000743; https://itmctr.ccebtcm.org.cn/mgt/project/view/-5368318132552339899.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/89891.
OBJECTIVE: This study aims to determine whether KGM is noninferior to oseltamivir in improving the clinical outcomes in patients with influenza and to assess the safety profile of KGM.
METHODS: This study is a multicenter, open-label, randomized controlled trial to be conducted in 3 tertiary grade A hospitals in China. Eligible participants with influenza will be randomly assigned in a 1:1 ratio to receive either KGM or oseltamivir for 5 days. A total of 184 participants will be enrolled, with 92 (50%) participants in each group. The primary outcome is time to clinical alleviation. Secondary outcomes include time to defervescence, time to onset of antipyretic effect, individual influenza symptom scores, and total influenza symptom scores. Adverse events will be monitored throughout the trial to evaluate the safety of KGM.
RESULTS: This study was funded in July 2024. Recruitment began in September 2025 and is expected to be completed in June 2026. The study results are expected to be published by December 2026.
CONCLUSIONS: This protocol describes a multicenter randomized controlled trial designed to generate comparative evidence on the efficacy and safety of KGM for influenza treatment. The findings of this study are expected to provide initial clinical evidence supporting the use of KGM in the treatment of influenza, clarify its therapeutic value as a potential alternative to oseltamivir, and offer a novel alternative strategy for influenza management while contributing to the evidence base for integrating traditional Chinese medicine into influenza care.
TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry ITMCTR2025000743; https://itmctr.ccebtcm.org.cn/mgt/project/view/-5368318132552339899.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/89891.