Effects of Chinese herbal medicine on Patients with AECOPD Risk Window: study protocol for a Randomized Controlled Trial

Abstract Background Chronic Obstructive Pulmonary Disease (COPD) is a major chronic disease with high incidence, mortality, and prevalence. Acute exacerbations mostly occur in a centralized period after an acute exacerbation, during which are extremely easy to occur again. We call this “high-risk period” as the “AECOPD risk window” (AECOPD-RW). At present, Western medicine lacks specific guidance on the medication of AECOPD-RW. Chinese herbal medicine has good efficacy and advantages in the treatment of COPD. Based on the clear distribution of syndrome in the previous period, this study aims to evaluate the clinical efficacy and safety of Chinese herbal medicine on AECOPD-RW. Methods This proposed study is a multi-center, double-blind, randomized controlled trial (RCT) to compare the efficacy of two therapies for patients with AECOPD-RW. 336 subjects will be randomly assigned in a 1:1 ratio to experimental group or control group for 8 weeks treatment and 18 weeks follow-up. Based on health education and conventional treatment, the experimental group will receive Chinese herbal medicine granule according to Chinese medicine syndrome types, while the control group will receive Chinese herbal medicine placebo granule according to Chinese medicine syndrome types. The primary outcomes are acute exacerbation rate in the AECOPD-RW, COPD Assessment Test (CAT) in the AECOPD-RW, and secondary outcomes include time to the first acute exacerbation, degree of acute exacerbation in the AECOPD-RW, acute exacerbation rate in the follow-up period, degree of acute exacerbation in the follow-up period, lung function, mMRC, quality of life and index of security. Outcome measurements will be evaluated at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period. The results will provide evidence for the clinical efficacy and safety of traditional Chinese medicine in the treatment of AECOPD RW, and provide a reliable scheme for the treatment of AECOPD-RW. Discussion This is the first multicenter, randomized, double-blind, placebo-controlled parallel trial designed to investigate the efficacy of Chinese herbal medicine in the treatment of AECOPD-RW. The result of this RCT may help effectively reduce the possibility of AECOPD recurrence, change the course of disease deterioration, and provide evidence-based evidence for Chinese herbal medicine prevention and treatment of AECOPD-RW. Trial registration This trial was registered in ClinicalTrials.gov, NCT04851093. Registered on 14 April 2021.