Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Control group 1:Standard Western medical treatment plus placebo for Traditional Chinese Medicine (TCM) syndrome-differentiated treatment
Treatment Group 1:Standard Western medical treatment plus TCM syndrome-differentiated treatment
Control Group 2:Standard Western medical treatment plus placebo matching Gejie Dingchuan Capsule
Treatment Group 2:Standard Western medical treatment plus Gejie Dingchuan Capsule
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for stable chronic obstructive pulmonary disease (COPD).(2) GOLD grade 2–4.(3) Traditional Chinese Medicine (TCM) syndrome differentiation diagnosed as lung qi deficiency syndrome, lung-spleen qi deficiency syndrome, lung-kidney qi deficiency syndrome, or lung-kidney qi-yin deficiency syndrome.(4) Age = 60 years.(5) Voluntary participation in this study and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with other pulmonary diseases such as lung abscess or active pulmonary tuberculosis.(2) Patients with severe cardiovascular or cerebrovascular diseases (e.g., malignant arrhythmia, acute myocardial infarction).(3) Patients with severe liver diseases (e.g., cirrhosis, portal hypertension, bleeding from esophageal and gastric varices) or severe kidney diseases (e.g., dialysis, kidney transplantation).(4) Patients with malignant tumors or immunodeficiency diseases, or with an expected survival time < 6 months.(5) Patients unable to communicate normally due to impaired consciousness, various psychiatric disorders, etc.(6) Patients who have participated in other clinical trials within 1 month prior to enrollment.(7) Patients allergic to the investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual acute exacerbation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first acute exacerbation;Pulmonary Function;6-minute walk distance (6MWD)?;CAT score;mMRC score;SGRQ score;MNA Score;COPD-STES Score; | — |
Countries
China
Contacts
Public ContactZhang Chuantao
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed