NCT07456813

Clinical Study on Guben Kechuan Granules Promoting Disease Recovery by Regulating Immune-Inflammatory Dysregulation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease During the Peri-Discharge Period

Not yet recruiting NA Last updated 6 March 2026

What this trial tests

NA trial testing Guben Kechuan Granules group in Chronic Obstructive Pulmonary Disease (COPD) in 126 participants. Not yet recruiting.

Timeline

15 March 2026

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	Cuiling Feng
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	126
Start date	15 March 2026
Primary completion	31 December 2027
Estimated completion	31 December 2027

Drugs / interventions tested

• Guben Kechuan Granules group — full drug profile →
• Placebo Drug — full drug profile →

Conditions studied

• Chronic Obstructive Pulmonary Disease (COPD) — all drugs for Chronic Obstructive Pulmonary Disease (COPD) →

Sponsor

Cuiling Feng — full company profile →

Who can join

Adults 40 to 75, any sex, with Chronic Obstructive Pulmonary Disease (COPD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.