NCT Number: NCT07456813
Chronic Obstructive Pulmonary Disease (COPD) is one of the most common chronic airway diseases in China. Western medicine treatments have good clinical efficacy, but their effectiveness is limited in patients with Acute Exacerbation of COPD (AECOPD) during the peri-discharge period. Recurrent acute exacerbations remain an urgent clinical challenge to address.
Traditional Chinese Medicine (TCM) has certain advantages in treating chronic airway diseases. Among them, Guben Kechuan Granules are widely used in respiratory diseases such as emphysema and COPD. However, high-level evidence for the use of Guben Kechuan Granules in patients with AECOPD during the peri-discharge period is currently lacking, and its mechanism of action has not been fully clarified.This study enrolled 126 patients with AECOPD during the peri-discharge period, who were randomly divided into the experimental group and the control group using a central randomization system. Both groups received treatment under the guidance of clinical guidelines, and the experimental group was additionally administered Guben Kechuan Granules. Follow-up assessments were conducted at 4 weeks, 8 weeks, and 12 weeks after treatment initiation, with efficacy indicators evaluated at 12 weeks. The primary efficacy endpoint was the improvement in Forced Expiratory Volume in 1 second (FEV1), while the secondary endpoints included the St. George's Respiratory Questionnaire (SGRQ), Modified Medical Research Council (mMRC) Dyspnea Scale, COPD Assessment Test (CAT), and 6-Minute Walk Test (6MWT). This study aims to scientifically evaluate the clinical efficacy of Guben Kechuan Granules in treating AECOPD during the peri-discharge period and generate high-quality clinical evidence.By detecting COPD-related inflammatory indicators, T-cell subsets, transcriptomics, serum metabolomics, and lipidomics, the mechanism of action of Guben Kechuan Granules in this patient population will be clarified. The study intends to elucidate its molecular mechanism of inhibiting inflammatory cascades through metabolic regulation, and screen metabolite marker clusters that can predict the response to integrated TCM and Western medicine treatment, thereby providing objective evidence for individualized precision intervention strategies.
Trial opening soon.
Get Notified40 year–75 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
On the basis of receiving conventional treatment (referring to the 2025 GOLD Guidelines) and health education, patients in the Guben Kechuan Granules group were administered Guben Kechuan Granules. The granules were dissolved in warm water for oral administration at a dosage of 2 g each time, 3 times a day, for 12 consecutive weeks.
On the basis of receiving conventional treatment (referring to the 2025 GOLD Guidelines) and health education, patients in the control group were administered placebo. The placebo was dissolved in warm water for oral administration at a dosage of 2 g each time, 3 times a day, for 12 consecutive weeks.
Time frame: Collected at baseline, 2 weeks post-treatment, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
The degree of improvement in Forced Expiratory Volume in 1 second (FEV1) of patients during the study period.
Time frame: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
The changes in patients' St. George's Respiratory Questionnaire (SGRQ) scores during the study period.
The SGRQ is a validated tool for assessing health-related quality of life in patients with chronic obstructive pulmonary disease. Scores range from 0 to 100, with higher scores indicating worse respiratory-related quality of life.
Time frame: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
The changes in patients' Modified Medical Research Council (mMRC) Dyspnea Questionnaire scores during the study period.
The mMRC scale is a 5-point scale (ranging from 0 to 4) used to grade the severity of dyspnea. Higher scores indicate more severe dyspnea.
Time frame: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
The changes in patients' COPD Assessment Test (CAT) Questionnaire scores during the study period.
The CAT is an 8-item questionnaire that measures the impact of COPD on a patient's health status. Scores range from 0 to 40, with higher scores indicating a greater negative impact of COPD on health status.
Time frame: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
The changes in patients' 6-Minute Walk Test (6MWT) during the study period
Contact information is provided by the study sponsor or research team.
Cuiling Feng
Other
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