Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) 40 years = age = 85 years, both male and female subjects; (2) Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD) defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2024 edition) and the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (Revised Edition 2021)," with pulmonary function classified as Grade I or II; (3) Patients in a stable phase, with no respiratory infections or acute exacerbations of COPD within the 4 weeks prior to screening; (4) Patients diagnosed with abnormal phlegmatic type according to Uighur medicine; (5) Patients have been informed and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with comorbidities such as bronchiectasis, asthma, pulmonary malignancies, or active pulmonary tuberculosis; 2. Patients who experienced an acute exacerbation within the past 4 weeks prior to enrollment; 3. Patients unable to cooperate with pulmonary function tests; 4. Patients who have been taking traditional Chinese herbal medicine (e.g., Astragalus, Ginseng, Codonopsis) for (regulation) over a long period; 5. Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases, or mental disorders; 6. Patients with abnormal liver function (ALT or AST = 2 ULN) or renal function (serum creatinine = 2 ULN); 7. Patients with a history of allergy or hypersensitivity to any component of the investigational drug, or those deemed by the investigator to have conditions that prohibit the use of the investigational drug; 8. Patients who have participated in or plan to participate in other clinical trials within 1 month prior to screening or during the observation period; 9. Other patients deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function FEV1 peak change value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary Function; Acute Exacerbation Frequency;The first time an acute exacerbation occurs.;Chronic Obstructive Pulmonary Disease (COPD) Assessment Test;Cough and Sputum Production Assessment Questionnaire;Health Survey Brief Form;Modified British Medical Research Council Dyspnea Questionnaire; | — |
Countries
China
Contacts
Xinjiang Uyghur Autonomous Region Uyghur Medical Hospital (Xinjiang Uyghur Autonomous Region Second People's Hospital)