chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Treatment group:JianPi YiFei III Granules + Conventional treatment
Control group:JianPi YiFei III Granules placebo + Conventional treatment
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40-85 years; 2. Diagnosed with COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2023), with lung function classified as grade 2 to 4; 3. CAT score >= 10; 4. With stable COPD, no respiratory infections or acute exacerbations of COPD within four weeks before screening; 5. No acute exacerbations of COPD occurred from the screening period to the inclusion visit; 6. With the TCM syndrome of qi deficiency phlegm stasis syndrome; 7. Inhalation therapy for at least 3 months to the screening period; 8. At least one or more moderate acute exacerbations during last year; 9. Informed and have signed the informed consent file.
Exclusion criteria
Exclusion criteria: 1. Complicated with bronchiectasis, asthma, obstructive sleep apnea syndrome, malignant lung tumor, active pulmonary tuberculosis, etc; 2. With concurrent pulmonary infection at present or nearly 4 weeks; 3. Previous pneumonectomy, or lung volume reduction within 12 months prior to screening; 4. Inability to cooperate with pulmonary function testing or limited mobility to complete the 6-minute walk test; 5. With long-term use of traditional Chinese medicine diet (such as astragalus, ginseng, Codonopsis and other traditional Chinese medicine); 6. With long-term non-drug treatment such as pulmonary rehabilitation; 7. Using long-term oxygen therapy (oxygen therapy time > 15 h/d) or home non-invasive ventilation; 8. With severe cardiovascular, cerebrovascular, liver or kidney diseases, mental disorders, or cancer; 9. With abnormal liver function [ALT or AST >= 1.5 times the upper limits of normal (ULN)] or abnormal kidney function (serum creatinine >= 1.5 times ULN); 10. Patients with a history of allergy or hypersensitivity reaction to the investigational drug components, or patients believed by the investigator to have diseases that should prohibit the use of the investigational drug; 11. Poor compliance or ineligible for the study at the judgment of the investigator; 12. Patients attending or planning to participate in other clinical trials, 1 month before the screening period and during the observation period; 13. Pregnant, intended pregnant or lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual average frequency of acute exacerbations; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first acute exacerbation;Severity of acute exacerbation;Incidence of acute exacerbation;COPD Assessment Test (CAT);Lung function;Cough and sputum assessment questionnaire (CASA-Q);6 minutes walking distance (6MWD);Modified Medical Research Council dyspnea scale (mMRC);BODE index; | — |
Countries
China
Contacts
Public ContactLei Wu
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed