Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria of Western medicine, with severity classified as Grade I or Grade II: namely the non-respiratory failure group and the acute respiratory failure–non-life-threatening group. 2) Meet the diagnostic criteria of traditional Chinese medicine, with syndrome differentiation of external cold and internal fluid retention. 3) Aged 40 to 80 years, regardless of gender. 4) Subjects have given informed consent and signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1) Patients with bronchiectasis, cystic fibrosis, pulmonary tuberculosis, or lung cancer. 2) Patients with concomitant severe cardiovascular or cerebrovascular diseases, hepatic or renal insufficiency, rheumatic immune diseases, coagulation disorders, malignant tumors, or other underlying diseases. 3) Patients requiring invasive mechanical ventilation; patients with clinically confirmed or highly suspected pulmonary embolism. 4) Patients with a history of mental illness, alcoholism, or drug abuse. 5) Patients with allergic constitution, or those allergic to the study drugs or related treatments. 6) Pregnant or lactating women, and women during menstruation. 7) Patients whose liver function (ALT, AST) or renal function (serum creatinine) exceeds twice the upper limit of normal. 8) Individuals who have participated in or are currently participating in other clinical trials within the past 3 months. 9) Patients who refuse to take traditional Chinese medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total effective rate;Change in BCSS score on Day 7 relative to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM Syndrome Score;Inflammatory markers;Arterial blood gas (ABG);Pulmonary function: FEV1, FVC, FEV1/FVC%;6-Minute Walk Test (6MWT) ;COPD Assessment Test score;Length of hospital stay;Incidence of endotracheal intubation during hospitalization; | — |
Countries
China
Contacts
Guangdong Second Provincial Traditional Chinese Medicine Hospital