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

March 3, 2026 updated by: Cuiling Feng

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test group
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
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.
Placebo Comparator: control group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of improvement in Forced Expiratory Volume in 1 second (FEV1)
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.
Collected at baseline, 2 weeks post-treatment, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
St. George's Respiratory Questionnaire (SGRQ) score
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.
Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
Modified Medical Research Council (mMRC) Dyspnea Questionnaire
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.
Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
COPD Assessment Test (CAT) Questionnaire
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.
Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
6-Minute Walk Test (6MWT)
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
Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cuiling Feng

Collaborators

Linfen Central Hospital
Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
Traditional Chinese Medicine Hospital of Changji Hui Autonomous Prefecture, Xinjiang
Jinan Hospital of Integrated Traditional Chinese and Western Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025PHB591-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

have not decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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