chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Experimental group:Jianpi Shufei Granules
Control group:Jianpi Shufei Granules placebo
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 40 years and < 85 years, no gender limit; 2. Meet the COPD diagnostic criteria defined by GOLD, graded as 1-2, and in a stable phase; 3. TCM syndrome differentiation is qi deficiency and phlegm obstruction; 4. Sign the informed consent form and agree to share the information.
Exclusion criteria
Exclusion criteria: 1. Patients with bronchial asthma, bronchiectasis, obstructive sleep apnea syndrome, lung cancer, active pulmonary tuberculosis; 2. TCM syndrome differentiation is dominated by Yin deficiency; 3. COPD patients who have experienced acute exacerbation within 4 weeks before enrollment; 4. Have a history of allergy or hypersensitivity to any study drug component, or be considered by the investigator to be known to have a disease that should prohibit the use of the study drug; 5. Those who cannot cooperate with the completion of the pulmonary function test; 6. Patients who have been taking traditional Chinese medicine diets (such as astragalus, ginseng, Codonopsis and other Chinese medicinal materials) for a long time; 7. Patients with severe cardiovascular and cerebrovascular, liver and kidney diseases or mental diseases; 8. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) or serum creatinine (Scr) exceeds 1.5 times the upper limit of normal; 9. Those with poor compliance; 10. Those who have received any investigational drug treatment within 1 month before the screening visit; 11. Those who participated or planned to participate in other clinical trials during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAT score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function parameters;Acute exacerbation per year;Time to first exacerbation;Quality of life assessment (CCQ questionnaire);CASA score;COPD Patient Quality of Life Assessment Questionnaire (mmrc);6 minutes walking distance;Security indicators; | — |
Countries
China
Contacts
Public ContactLin Lin
Outcome results
None listed