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

Area of Science:

• Integrative Medicine
• Infectious Diseases
• Clinical Pharmacology

Background:

• Influenza causes significant global health burdens annually.
• Current treatments like oseltamivir face challenges due to resistance and side effects.
• Kanggan mixture (KGM), a traditional Chinese medicine, shows promise but lacks high-quality comparative data.

Purpose of the Study:

• To determine if KGM is non-inferior to oseltamivir for influenza treatment.
• To evaluate the clinical outcomes and safety profile of KGM compared to oseltamivir.
• To provide evidence for KGM's therapeutic value as an alternative influenza therapy.

Main Methods:

• A multicenter, open-label, randomized controlled trial involving 184 influenza patients.
• Participants randomly assigned to receive either KGM or oseltamivir for 5 days.
• Primary outcome: time to clinical alleviation; Secondary outcomes: time to defervescence, symptom scores, and adverse events.

Main Results:

• Study funded July 2024; recruitment September 2025 - June 2026.
• Results publication expected by December 2026.
• No results available yet as the study is ongoing.

Conclusions:

• This trial will generate crucial comparative data on KGM efficacy and safety for influenza.
• Findings may support KGM as a viable alternative to oseltamivir.
• The study aims to advance the integration of traditional Chinese medicine in influenza management.