Yifei Moxibustion Treatment for Acute Exacerbations of Asthma: Study Protocol for a Randomized Controlled Trial

Abstract Introduction: Asthma is one of the most prevalent global chronic respiratory diseases that significantly impairs patients' quality of life worldwide. While Yifei moxibustion has demonstrated therapeutic potential in managing chronic airway disease through extensive clinical application, its efficacy in asthma treatment remains insufficiently validated due to the absence of rigorously controlled, high-quality randomized clinical trials. This study aims to systematically evaluate the clinical efficacy and safety of Yifei moxibustion in asthma management while concurrently investigating its potential therapeutic mechanism.Methods: This multicenter randomized controlled trial will enroll 384 participants with poorly controlled asthma, randomly allocating them to the Yifei moxibustion group and the usual care control group at a 1:1 ratio. The Yifei moxibustion group will receive moxibustion treatment on the Governor Channel. The moxibustion treatment consists of 90-minute per session every 10 days, starting 10 days before the first dog-days. Each treatment course includes 5 times, with two consecutive courses administered, while the control group received usual care without moxibustion. The primary outcome measure is the annual number of acute exacerbations. Secondary outcomes comprise Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), and Asthma Quality of Life Questionnaire (AQLQ) scores, assessed at baseline and every 13 weeks post-treatment. Pulmonary function and fractional exhaled nitric oxide (FeNO) measurements will be conducted at baseline, 52 weeks, and 104 weeks. Laboratory blood biochemical analysis will be conducted at baseline and at the end of treatment to explore the potential mechanism of Yifei moxibustion in regulating asthma.Conclusion: This trial will provide evidence on the efficacy and safety of Yifei moxibustion in reducing asthma acute exacerbations and further shed light on the potential regulatory mechanism, thereby establishing a theoretical foundation for its clinical application in asthma management.Trial registration: Clinical Trials.gov NCT 06777472. Registered on 10 January 2025.