Chronic Obstructive Pulmonary Disease(COPD)
Conditions
Interventions
Treatment group:Qianli Jianbu Formula
Control group:Qianli Jianbu Formula Placebo
Sponsors
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.In patients diagnosed with COPD according to the GOLD guideline, the post-bronchodilator (salbutamol) FEV1/FVC ratio is <70%; 2.Be in a stable phase, with no respiratory tract infection or acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 4 weeks prior to the screening visit, and be able to comply with the protocol's requirements for background therapy and concomitant medication use; 3.Have a history of COPD of at least 1 year's duration prior to the screening visit, and have experienced at least one acute exacerbation of COPD within the 12 months prior to the screening visit; 4..Aged 40 to 80 years; 5.Meet the TCM syndrome of Fei Zhang (lung distension) in the stable phase, presenting with qi deficiency of the lung, spleen, and kidney, and phlegm-blood stasis binding; 6..The subject provides informed consent and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Presence of other pulmonary diseases (e.g., Bronchiectasis of the Main Bronchus,cystic fibrosis, bronchiolitis, pneumonectomy, lung cancer, diffuse interstitial lung disease, pulmonary tuberculosis, severe bronchiectasis, pulmonary tumors, etc.); 2.Presence of severe cardiovascular diseases (congestive heart failure of New York Heart Association [NYHA] class III–IV; significant arrhythmia or valvular abnormality affecting hemodynamic status; history of unstable angina or myocardial infarction within the past month); 3.Presence of severe digestive, endocrine, neurological, or other systemic diseases. 4.Presence of severe psychiatric disorders or history of depressive disorders; women who are pregnant, breastfeeding, planning pregnancy, or unable to use reliable contraception; 5.Inability to complete the Six-minute Walk Test due to lower limb activity limitation or other reasons; 6.Participation in any other clinical trial within 30 days prior to screening, or prior enrollment in this trial; 7.Patients who require long-term oxygen therapy, have unstable doses of systemic corticosteroids or doses exceeding the equivalent of prednisone 10 mg/day, or require long-term antibiotic therapy, etc. 8.Known allergy or contraindication to any component of the investigational drug, rescue medication, or their excipients; 9.Any concomitant disease or condition that may interfere with trial procedures or evaluations, or any other situation deemed by the investigator as unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exercise tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of COPD acute exacerbations;Pulmonary function;Clinical symptoms;Dyspnea grading;Quality of life; | — |
Countries
China
Contacts
Public ContactXiaojuan Li
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed