Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Experimental group:Western medicine standardized treatment combined with Guben Kechuan Granules.
Control Group:Western medicine standardized treatment combined with Gu Ben Ke Chuan Granules simulator
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western medical diagnostic criteria for COPD, with FEV1/FVC < 70%, and the percentage of FEV1 relative to the predicted normal value (FEV1%pred): 20% < FEV1%pred < 80%; (2) Is in the peri-discharge phase of AECOPD; (3) Has a syndrome differentiation consistent with the traditional Chinese medicine pattern of deficiency in the lung, spleen, and kidney; (4) Meets the criteria for a state of frailty; (5) Is aged between 40 and 75 years, with no restrictions on gender; (6) Agrees to participate in this study and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subjects with allergy to the investigational drug or its components; (2) Subjects with elevated levels of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamyl transpeptidase (GGT), alkaline phosphatase (ALP), total bilirubin (TBIL), direct bilirubin (DBIL), or elevated serum creatinine (Scr) above the upper limit of reference values; (3) Subjects with severe cardiovascular diseases, hematological disorders, malignant tumors, or other serious underlying conditions; (4) Subjects with other respiratory diseases, such as interstitial lung disease or bronchiectasis; (5) Subjects with mental status unable to comply with the observation or cognitive impairment; (6) Pregnant women, those planning pregnancy, or breastfeeding women; (7) Subjects who have participated in other drug trials within the past 3 months; (8) Subjects deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of acute exacerbations in COPD patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frailty Status in COPD Patients (Fried Frailty Phenotype Scale);Skeletal muscle function;Pulmonary Function;COPD Patient Self-Assessment Test Questionnaire (CAT) Scoring;Modified Medical Research Council (mMRC) dyspnea scale;TCM Syndrome Score; | — |
Countries
China
Contacts
Public ContactMiao Qing
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed