Chronic obstructive pulmonary disease
Conditions
Interventions
experimental group:SAN HUAN GU BEN ZHI KE Granule
control group:placebo
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with COPD in stable period; 2. In the last 4 weeks, the condition was stable and no acute aggravation was found; 3. COPD acute exacerbation risk assessment is high risk(In the past 1 years, the number of acute exacerbations was more than 2 times, or the number of hospitalized patients was 1 times more than that of the previous year because of acute exacerbation); 4. Patients with lung and spleen qi deficiency; 5. Aged between 40 and 80 years, and the sex is not limited.; 6. Volunteer to accept treatment and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. At present or within 4 weeks, pneumonia and / or moderate or severe chronic obstructive pulmonary disease are more acute; 2. Previous lung resection or lung volume reduction surgery within the first 12 months of screening; 3. Using long term oxygen therapy (oxygen therapy time >15h/d) or mechanical ventilation; 4. Patients with asthma, active tuberculosis, lung cancer, bronchiectasis, pulmonary embolism, pulmonary heart disease, interstitial lung disease or other active diseases; 5. The 6 minute walk test is difficult to complete the limited movement of the lower limbs; 6. Suffering from severe hypertension, diabetes, tumor, primary heart, liver, kidney, blood system disease control is not ideal; 7. The renal Scr exceeds the limit of reference value by 1.5 times, or the upper limit of reference value of liver function tests AST or ALT is more than 2 times; 8. Patients with congenital or acquired immunodeficiency disease; 9. Patients known or suspected of alcohol or drug abuse; 10. Patients with mental illness, mental retardation, mobility problems or other restrictions that will restrict the effectiveness of informed consent in this study; 11. Pregnant or lactating women or those who plan to be pregnant during the study period; 12. Allergy to drug components; 13. Patients who use oral glucocorticoids at present; 14. Patient who attend other clinical trials in the last 3 months; 15. Researchers believe that it is not appropriate to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of AECOPD occurrences; | — |
Secondary
| Measure | Time frame |
|---|---|
| AECOPD: after treatment for the first time, time interval, duration and severity;;TCM syndrome scores;pulmonary function test (FEV1, FVC, MMEF, FEF);Symptom assessment: mMRC;Quality of life: CAT;Exercise ability: 6 minutes walk distance;BODE index scores;Combined use of drugs;Mortality: death rate of all causes, chronic obstructive pulmonary disease; | — |
Countries
China
Contacts
Public ContactLI Demin
China-Japan Friendship Hospital
Outcome results
None listed