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

NCT07456813 | Not Yet Recruiting

• 1 other identifier: 2025PHB591-001
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Acute Exacerbation of Chronic Obstructive Pulmonary Disease During the Peri-Discharge Period; Guben Kechuan Granules

Outcome Measures

Primary Outcomes (1)

• Degree of improvement in Forced Expiratory Volume in 1 second (FEV1)

  The degree of improvement in Forced Expiratory Volume in 1 second (FEV1) of patients during the study period.

  Collected at baseline, 2 weeks post-treatment, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment

Secondary Outcomes (4)

• St. George's Respiratory Questionnaire (SGRQ) score

  Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment

• Modified Medical Research Council (mMRC) Dyspnea Questionnaire

  Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment

• COPD Assessment Test (CAT) Questionnaire

  Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment

• 6-Minute Walk Test (6MWT)

  Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment

Study Arms (2)

test group

EXPERIMENTAL

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.

Drug: Guben Kechuan Granules group

control group

PLACEBO COMPARATOR

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.

Drug: Placebo Drug

Interventions

Guben Kechuan Granules group DRUG

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.

test group

Placebo Drug DRUG

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.

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD), with lung function classified as Grade II-IV (Groups B and E).
• Be in the peri-discharge period of Acute Exacerbation of COPD (AECOPD).
• Conform to the Traditional Chinese Medicine (TCM) syndrome of spleen deficiency with excessive phlegm and insecure kidney qi.
• Aged 40-75 years, regardless of gender.
• Be an inpatient.
• Have no prior use of Guben Kechuan Granules.
• Be willing to participate in this study and sign the informed consent form.

You may not qualify if:

• Have airflow limitation caused by other respiratory diseases such as bronchial asthma, bronchiectasis, pulmonary tuberculosis, and lung cancer.
• Have severe concurrent diseases of the heart, brain, liver, kidney, etc., which render the patient unable to cooperate with exercise.
• Have an impaired immune system or be receiving long-term ·immunosuppressive therapy.
• Be currently participating in another interventional clinical trial of drugs or medical devices.

Sponsors & Collaborators

• Cuiling Feng: lead
• Linfen Central Hospital: collaborator
• Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• Traditional Chinese Medicine Hospital of Changji Hui Autonomous Prefecture, Xinjiang: collaborator
• Jinan Hospital of Integrated Traditional Chinese and Western Medicine: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cuiling Feng

CONTACT

010-88325882; fengcuiling@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Peking University People's Hospital

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: March 6, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03