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| Name | Class |
|---|---|
| Linfen Central Hospital | UNKNOWN |
| Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
| Traditional Chinese Medicine Hospital of Changji Hui Autonomous Prefecture, Xinjiang | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuiling Feng | Contact | 010-88325882 | fengcuiling@sina.com |
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| Jinan Hospital of Integrated Traditional Chinese and Western Medicine | UNKNOWN |
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| 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. |
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| 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. | 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. | 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 | Collected at baseline, 4 weeks post-treatment, 8 weeks post-treatment, and 12 weeks post-treatment |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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