Chronic obstructive pulmonary disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with stable COPD according to GOLD Guidelines 2019; 2. Meet the diagnostic criteria of Mongolian medicine; 3. Patients in the stable phase of CHRONIC obstructive pulmonary disease (if the disease exacerbates after enrollment and causes AECOPD, the condition is stabilized and the disease condition shall be evaluated again after the hospital discharge in the month,when meets the inclusion criteria of the last consecutive visit (the last visit period before acute exacerbation), with lung function FEV1/FVC<70%, and can follow the trial regimen; 4. A history of COPD for at least one year prior to V1, with at least twice exacerbations of COPD or once hospitalization due to exacerbations in the past year; 5. Aged 18 to 75 years; 6. The subject has informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other lung diseases (cystic pulmonary fibrosis, bronchiolitis, pneumonectomy, lung cancer, diffuse interstitial lung disease, tuberculosis, severe bronchiectasis, lung tumors, etc.); 2. Serious cardiac diseases (congestive heart failure,NYHA classification of severity is III~IV severity; Significant arrhythmias affecting hemodynamic status (affecting hemodynamic atrial fibrillation, atrial flutter, supraventricular tachycardia, degree II or higher atrioventricular block, ventricular tachycardia); History of unstable angina pectoris or myocardial infarction within the last month); 3. Serious diseases of digestive system, endocrine system, nervous system or other diseases; 4. A history of serious mental illness or depression; 5. Resting heart rate >120 beats/min, or systolic blood pressure >180mmHg, or diastolic blood pressure >100mmHg; 6. Those who were unable to complete the six-minute walking test due to limited lower limb activities; 7. Abnormal laboratory tests with clinical significance (e.g. ALT>2ULN, AST>2ULN, or Scr>1.5ULN) require further clinical evaluation; 8. Alcohol and drug abuse in the year prior to the test; 9. Suspected allergy to, or contraindications to, any of the following substances, including the active ingredient of the test drug or first-aid drug and other ingredients contained in the test drug or first-aid drug; 10. Pregnant, lactating women, planning to become pregnant or unable to use reliable contraceptive methods; 11. Patients who have participated in any clinical trial within 30 days prior to screening, or who have previously been enrolled in this trial; 12. Suffers from any concomitant disease that may interfere with the procedure or evaluation of the study, or is otherwise deemed unsuitable for inclusion in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pulmonary function;arterial blood gas analysis; | — |
Countries
China
Contacts
Affiliated Hospital of Inner Mongolia University for the Nationalities