Chronic Obstructive Pulmonary Disease (COPD)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
A study testing Guben Kechuan Granules group in people with Chronic Obstructive Pulmonary Disease (COPD), run by Cuiling Feng.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Guben Kechuan Granules group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Guben Kechuan Granules group, Placebo Drug
- Keywords
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease During the Peri-Discharge Period, Guben Kechuan Granules
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guben Kechuan Granules groupDrug
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 DrugDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
Modified Medical Research Council (mMRC) Dyspnea Questionnaire
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.
Measured: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
COPD Assessment Test (CAT) Questionnaire
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.
Measured: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
6-Minute Walk Test (6MWT)
The changes in patients' 6-Minute Walk Test (6MWT) during the study period
Measured: Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cuiling Feng
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Cuiling Feng, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456813
- Sponsor's protocol ID
- 2025PHB591-001
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: have not decided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07456813
- Acronym / sponsor ID
- 2025PHB591-001
- Keywords
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease During the Peri-Discharge Period, Guben Kechuan Granules
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Cuiling FengUniversity, hospital or other
- 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 start
- 15 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: Guben Kechuan Granules groupOn 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. |
| control group | Placebo comparator | Drug: Placebo DrugOn 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guben Kechuan Granules groupOn 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 | test group |
| Placebo DrugOn 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 | control group |
Primary outcome
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.
4 secondary outcomes
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
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
COPD Assessment Test (CAT) Questionnaire
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided. have not decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Guben Kechuan Granules group in people with Chronic Obstructive Pulmonary Disease (COPD), run by Cuiling Feng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cuiling Feng (010-88325882, fengcuiling@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.