The Effectiveness of Yong Chong Cao Capsule in Patients With Mild to Severe COPD: A Multi‐Center, Randomized, Double‐Blinded, Active‐Controlled Trial

ABSTRACT Background and objective Bailing Capsules (BLC) and Yong Chong Cao Capsules (YChCC) share similar medicinal components, but Yong Chong Cao benefit from more advanced cultivation and large‐scale production. This study systematically compared their therapeutic effects in patients with mild‐to‐severe Chronic Obstructive Pulmonary Disease (COPD). Patients and method This study was designed as a multicenter, single‐blinded, randomized, active‐controlled trial. 240 COPD patients were randomized 1:1 to receive YChCC or BLC for 24 weeks, followed by a 24‑week follow‑up. The primary endpoints were number of acute exacerbations. Secondary outcomes included, time to first exacerbation, and exacerbation duration, forced expiratory volume in 1 s (FEV 1 ), FEV 1 %, forced vital capacity (FVC), FVC%, FEV 1 /FVC%, modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), and Chronic Obstructive Pulmonary Disease Clinical Questionnaire (CCQ). Results A total of 208 patients completed the trial (full analysis set, FAS), and 178 comprised the per‑protocol set (PPS). Compared with BLC, YChCC significantly reduced the number of acute exacerbations (FAS: p = 0.002; PPS: p = 0.003) and prolonged time to first exacerbation. No significant between‑group differences were observed in lung function parameters or mMRC, CAT, and CCQ scores. Conclusion YChCC represent a promising adjuvant therapy for patients with stable COPD, ranging from mild to severe. They significantly prolong the time to the first acute exacerbation and reduce the frequency of acute exacerbations, thereby offering potential benefits in managing COPD. Trial registration This trial has been registered at ClinicalTrials.gov under the registration number NCT03745261. Trial registration number (if clinical trial) NCT0374526