Chronic Obstructive Pulmonary Disease Stable Period
Conditions
Interventions
High-dose group:Qibai Pingfei Granules, 2 packets per dose, 3 times daily.
Low-Dose Group in the Trial:Qibai Pingfei Granules 1 sachet per dose + Qibai Pingfei Granules simulator 1 sachet per dose, 3 times daily.
Placebo group:Qibai Pingfei Granules Simulated Agent: 2 packets per dose, 3 times daily.
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western medical diagnostic criteria for COPD and is in a stable phase; (2) Pulmonary function classified as Grade II to IV; (3) Meets the diagnostic criteria for the traditional Chinese medicine pattern of Qi deficiency with phlegm-stasis obstructing the lungs; (4) Age between 40 and 75 years; (5) At least 1 year of COPD history prior to screening, with =1 episode of moderate or severe AECOPD in the past year; (6) Stable condition within the past 4 weeks before screening, without respiratory infections or AECOPD; (7) Either smoking cessation or maintaining stable cigarette consumption; (8) Informed consent obtained, with the informed consent form signed.
Exclusion criteria
Exclusion criteria: (1) Combine other respiratory diseases (excluding COPD, such as bronchiectasis, bronchial asthma, pulmonary tuberculosis, pulmonary fibrosis, pulmonary embolism, pulmonary hypertension, diffuse interstitial lung disease, pulmonary tumors, etc.); (2) The first-second maximum expiratory volume (FEV1) 120 beats per minute, and/or systolic blood pressure > 180 mmHg, and/or diastolic blood pressure > 100 mmHg; (6) Serum creatinine exceeding the upper limit of normal, or ALT and/or AST exceeding 1.5 times the upper limit of normal (baseline only); (7) Patients with restricted lower limb mobility or unable to complete the six-minute walk test; (8) Patients with a history of allergy to any component of the investigational drug, intolerance, or allergic constitution; (9) History of alcohol abuse and/or drug addiction within the past year; (10) Pregnant, breastfeeding women, those planning pregnancy, or unable to adopt reliable contraceptive measures; (11) Participation in other interventional clinical studies that may affect the results of this study; (12) Other situations deemed unsuitable for inclusion in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The assessment of the number of AECOPD episodes during treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time from COPD treatment to the first AECOPD occurrence.;First Episode of AECOPD Duration;The severity of the first AECOPD;Change in 6-minute walking distance from baseline;The absolute value of 6-minute walk distance percentage relative to predicted value change from baseline.;Chronic Obstructive Pulmonary Disease (COPD) Patient Self-Assessment Test Questionnaire (CAT);Modified Medical Research Council Respiratory Questionnaire (mMRC);St. George's Respiratory Questionnaire (SGRQ);Changes in pulmonary function indices (including FEV1, FVC, and FEV1/FVC) after inhalation of bronchodilators.;Traditional Chinese Medicine (TCM) Syndrome Efficacy;Single symptom resolution rate;Medication use during the study period;The number of AECOPD episodes in the one year after discontinuation.;All-cause mortality, attributable mortality; | — |
Countries
China
Contacts
Public ContactMiao Qing
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed