Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Treatment group:Conventional Western medical treatment plus Chinese herbal medicine granules
Control Group:Conventional Western medical treatment + Chinese herbal granule placebo
Sponsors
Chengdu University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 40 years = age = 80 years; 2) Stable condition without acute exacerbation in the past 4 weeks; 3) Meets the diagnostic criteria for stable COPD as per the GOLD 2025 guidelines; 4) Meets the diagnostic criteria for phlegm retention obstructing the lung; 5) Clinically diagnosed with COPD for =1 year, and classified as GOLD I~IV according to GOLD spirometry criteria; 6) Written informed consent obtained from the patient or their legally authorized representative and signed the "Informed Consent Form". Note: Only patients who meet all of the above 6 criteria are eligible for inclusion in the study.
Exclusion criteria
Exclusion criteria: 1) Those with severe cardiovascular (severe arrhythmia, acute myocardial infarction, heart failure (NYHA III-IV class), severe hypertension, cerebral hemorrhage, or cerebral infarction), neurological (tremors, peripheral neuropathy), hematological (severe anemia, etc.), immunological (immune diseases with pulmonary damage), or malignant tumors; 2) Those with other active or clinically significant respiratory diseases that may significantly impact the study, such as active pulmonary tuberculosis, bronchial asthma, severe bronchiectasis, primary pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases; 3) Those who have undergone segmentectomy, wedge resection, lobectomy, pneumonectomy, or lung volume reduction surgery (including bronchoscopic lung volume reduction surgery) due to COPD; 4) Those requiring long-term oxygen therapy (LTOT) with oxygen therapy duration >15 hours/day; 5) Those unable to complete pulmonary function tests, walk independently, or cooperate with questionnaire completion; 6) Those with known allergies to components of the study drug; Note: Participants meeting any of the above criteria should not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of acute exacerbations in chronic obstructive pulmonary disease patients during stable phase of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time when the first acute exacerbation occurred.;Pulmonary Function Tests (PFTs) ;All-cause mortality during treatment;Chronic Obstructive Pulmonary Disease Assessment Test scoring;modified Medical Research Council score;Serum inflammatory mediators:interleukin-6, interleukin-8, interleukin-10; | — |
Countries
China
Contacts
Public ContactGao Peiyang
Chengdu University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed