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Войти в исследования Frontiers in pharmacology · 2026
Evaluating Cordyceps militaris capsules on post-bronchodilator FEV1 decline in patients with COPD: a study protocol for double-blind, randomized, placebo-controlled trial.
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Lin Siqi, Liao Tianming, Fan Feiting, Chen Yuanbin, Yan Yue, Dong Hangming, Zhan Shaofeng, Zhang Yuanbing, Xiao Kun, Lin Lin, Wu Lei
Аннотация
BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is characterized by a progressive deterioration of lung function, which occurs at its fastest rate in the early stages (GOLD I-II). Preliminary clinical investigation has suggested that Cordyceps militaris capsules can improve post-bronchodilator forced expiratory volume in 1 s (FEV1) in mild-to-moderate COPD. However, previous studies were limited by the absence of placebo control. Therefore, this trial is designed to evaluate the efficacy and safety of Cordyceps militaris capsules versus placebo in improving post-bronchodilator FEV1 in patients with mild-to-moderate stable COPD.
METHODS: This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial involving 160 eligible patients aged between 40 and 85 years. After a 1-week run-in period, participants are randomized in a 1:1 ratio to receive either Cordyceps militaris capsules or placebo capsules for 24 weeks, and are followed for an additional 24 weeks. The primary outcome measure is the change in post-bronchodilator FEV1. Secondary outcome measures comprise additional lung function parameters, such as pre-bronchodilator FEV1, pre- and post-bronchodilator measures of forced vital capacity (FVC), FEV1/FVC ratio, mid-expiratory flow (MMEF), forced expiratory flow 75% (FEF75), forced expiratory flow 50% (FEF50). In addition, frequency of acute exacerbations, time to the first acute exacerbation, COPD Assessment Test (CAT), Cough and Sputum Assessment Questionnaire (CASA-Q), EuroQol five-dimension five-level questionnaire (EQ-5D-5L), and Modified Medical Research Council dyspnea scale (mMRC) are also included.
DISCUSSION: This study is designed to evaluate the therapeutic potential of Cordyceps militaris capsules and to provide a traditional Chinese medicine intervention for preserving lung function in mild-to-moderate stable COPD.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/, ChiCTR2400086743, identifier, ChiCTR2400086743.
METHODS: This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial involving 160 eligible patients aged between 40 and 85 years. After a 1-week run-in period, participants are randomized in a 1:1 ratio to receive either Cordyceps militaris capsules or placebo capsules for 24 weeks, and are followed for an additional 24 weeks. The primary outcome measure is the change in post-bronchodilator FEV1. Secondary outcome measures comprise additional lung function parameters, such as pre-bronchodilator FEV1, pre- and post-bronchodilator measures of forced vital capacity (FVC), FEV1/FVC ratio, mid-expiratory flow (MMEF), forced expiratory flow 75% (FEF75), forced expiratory flow 50% (FEF50). In addition, frequency of acute exacerbations, time to the first acute exacerbation, COPD Assessment Test (CAT), Cough and Sputum Assessment Questionnaire (CASA-Q), EuroQol five-dimension five-level questionnaire (EQ-5D-5L), and Modified Medical Research Council dyspnea scale (mMRC) are also included.
DISCUSSION: This study is designed to evaluate the therapeutic potential of Cordyceps militaris capsules and to provide a traditional Chinese medicine intervention for preserving lung function in mild-to-moderate stable COPD.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/, ChiCTR2400086743, identifier, ChiCTR2400086743.