Chronic obstructive pulmonary disease
Conditions
Interventions
Treatment group:Qilongtian Capsule
Control group:Qilongtian capsule placebo
Sponsors
Kunming Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with COPD according to GOLD guidelines, the FEV1/FVC ratio < 70% after the application of bronchodilator (albuterol), and they have lived in a high altitude (1500-3500m) area for a long time; 2) The disease process conformed to the TCM diagnostic criteria of Feizhang - Zongqi deficiency and phlegm and stasis intertwining; 3) follow the provisions of the trial protocol for the use of basic treatment and concomitant drugs; 4) 40 years old= age = 85 years old; 5) Have not participated in other drug clinical studies within 1 month before enrollment; 6) Subjects give informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Other lung diseases (main bronchiectasis, cystic pulmonary fibrosis, bronchiolitis, lung resection, lung cancer, diffuse interstitial lung disease, tuberculosis, severe bronchiectasis, lung tumors, etc.) ; 2) Severe cardiac disease (congestive heart failure, severity grade III~IV. according to NYHA classification; Significant cardiac arrhythmias or valvular abnormalities affecting hemodynamic conditions; History of unstable angina pectoris or myocardial infarction within the past 1 month); 3) Resting heart rate > 120 beats/min, or systolic blood pressure > 180mmHg, or diastolic blood pressure > 100mmHg; 4) Age 85 years old; 5) Severe digestive system, endocrine system, nervous system disease or other diseases; 6) Severe mental illness or history of depressive disorder, pregnant, lactating women, planning to become pregnant, or unable to use reliable contraceptive measures; 7) Those who have difficulty completing the six-minute walk test due to limited movement of the lower limbs; 8) Clinically significant abnormal laboratory test indicators (such as ALT>2ULN, AST>2ULN, or Scr>1.5ULN), requiring further clinical evaluation; 9) Patients who have participated in any clinical trial within 30 days prior to screening, or who have been previously enrolled in this trial; 10) Long-term use of systemic hormones, unstable doses, or hormone doses exceeding the dose equivalent to prednisone 10mg/d, or long-term use of antibiotics, etc.; 11) Alcohol and drug abuse in the 1 year prior to the trial; 12) Suspected allergy to any of the following substances, or contraindications to the use of any of the following substances, including: the active ingredients of the test drug and the rescue drug, and other components contained in the test drug or the rescue drug; 13) Suffering from any concomitant disease that may interfere with the trial procedure or trial evaluation, or other conditions that the investigator deems unsuitable for inclusion in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function; | — |
Secondary
| Measure | Time frame |
|---|---|
| C-reactive protein;IL-6;HIF-1a;IL-17b;TGF-ß1;MMP-9; | — |
Countries
China
Contacts
Public ContactSong Jiayi
Kunming Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed