Exploring the efficacy and safety of Antitoxin and Antipyretic Decoction in treating acute respiratory viral infections with Wind-Heat Obstruction of the Exterior and Heat Invading the Lung Defense a study protocol for a randomized controlled trial.

BACKGROUND

Acute respiratory viral infections are the most common diseases affecting the respiratory system. Currently, there is still a lack of specific antiviral drugs targeting various viruses. Traditional Chinese herbal medicine, with its diverse components and multiple therapeutic targets, has emerged as a promising treatment option. "Antitoxin and Antipyretic Decoction" (AAD) is a traditional herbal formula that has been reported to effectively reduce fever and alleviate associated symptoms in clinical practice. However, there is insufficient clinical research evaluating AAD for the treatment of acute respiratory viral infections. Therefore, this study is designed to assess the efficacy of AAD in treating acute respiratory viral infections.

METHODS

This is a single-center, randomized, double-blind, controlled trial. A total of 120 eligible patients will be randomly assigned in a 1:1 ratio to receive either AAD granules or placebo granules. The trial will last for 5 days, with follow-ups on days 3, 6, and 12. The primary outcome is the proportion of participants with complete fever resolution at Day 6. Secondary outcomes include time to complete fever resolution, time to initial fever reduction, use rate and average dose of emergency antipyretic medication, individual symptom scores (fever, fatigue, cough, muscle aches, taste and smell disturbances, diarrhea, nasal congestion, runny nose, headache, and fatigue) as both absolute values and change values, Traditional Chinese Medicine syndrome scores, and viral clearance time. Any adverse events occurring during the trial will be recorded by the researchers. A small-sample prospective pilot study was conducted from August 2024 to October 2024 to test the feasibility of the trial procedures; the main study described in this protocol has not yet commenced.

DISCUSSION: This study aims to provide evidence on the efficacy and safety of AAD in the treatment of acute respiratory viral infections.