Evidence map›Paper›PMID 42228931›Full record

ArticleJMIR research protocols2026

Efficacy and Safety of Kanggan Mixture for Influenza: Protocol for a Multicenter Open-Label Randomized Controlled Trial.

Yilan Gao, Yue Ge, Qian Wang, Zibo Sun, Shuo Dong, Yanfen Tang, Guicai Zhang, Xianmei Zhou, Hailang He

Abstract readClinical Trial Protocol
In one paragraph

Article in JMIR research protocols, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

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0 citing papers in PubMed.

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Yilan GaoAffiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China.ORCID 0009-0004-7903-0161
Yue GeAffiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China.ORCID 0009-0007-8312-2570
Qian WangAffiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China.ORCID 0009-0004-9382-9148
Zibo SunAffiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China.ORCID 0009-0001-1223-001X
Shuo DongAffiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China.ORCID 0009-0006-8097-7293
Yanfen TangNantong Hospital of Traditional Chinese Medicine, Nantong, Jiangsu Province, China.ORCID 0009-0006-3468-190X
Guicai ZhangYancheng Hospital of Traditional Chinese Medicine, Yancheng, Jiangsu Province, China.ORCID 0009-0003-6689-158X
Xianmei ZhouAffiliated Hospital of Nanjing University of Chinese Medicine, Department of Respiratory Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu Province, China.ORCID 0000-0003-0036-7876
Hailang HeAffiliated Hospital of Nanjing University of Chinese Medicine, Department of Respiratory Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu Province, China.ORCID 0000-0002-7798-500X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfluenza, 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.

objectiveThis 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.

methodsThis 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.

resultsThis 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.

conclusionsThis 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 registrationInternational Traditional Medicine Clinical Trial Registry ITMCTR2025000743; https://itmctr.ccebtcm.org.cn/mgt/project/view/-5368318132552339899. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/89891.

Indexed as

Drugs, Chinese HerbalInfluenza, HumanAdolescentAdultAntiviral AgentsChinaFemaleHumansMaleMulticenter Studies as TopicOseltamivirRandomized Controlled Trials as TopicTreatment OutcomeAntiviral AgentsDrugs, Chinese HerbalOseltamivirinfluenzakanggan mixtureprotocolrandomized controlled trialtraditional Chinese medicine

Identifiers

PMID42228931
PMCPMC13273194

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.