Chronic Obstructive Pulmonary Disease with acute exacerbation
Conditions
Interventions
Treatment group:Conventional Western medical treatment combined with Fei Qi Tan ointment.
Sponsors
Guangdong Medical University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 40-80 years, male or female; 2. Meets the diagnosis criteria for acute exacerbations of chronic obstructive pulmonary disease; 3. Meets the diagnosis criteria for phlegm-dampness obstructing the lung; 4. Signs the informed consent form and voluntarily participates in this study.
Exclusion criteria
Exclusion criteria: 1. Subjects with other severe respiratory diseases (e.g., acute asthma exacerbation, acute exacerbation of bronchiectasis, active interstitial lung disease, massive pleural effusion, pulmonary embolism, etc.); 2. Subjects requiring invasive mechanical ventilation; 3. Subjects with a history of pulmonary surgery within the past 12 months; 4. Subjects whose TCM syndrome does not meet the study requirements: although they meet the basic diagnostic criteria for phlegm-dampness obstructing the lung, they lack the pattern of spleen-lung qi deficiency; 5. Subjects with severe impairment of heart, liver, or kidney function (e.g., heart function class 3-4, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) exceeding twice the upper limit of normal, serum creatinine (Scr) exceeding 1.5 times the upper limit of normal); 6. Subjects with severe immunosuppressive diseases or long-term use of immunosuppressive agents (e.g., HIV infection, active pulmonary tuberculosis, invasive fungal infection, malignant tumors, organ transplantation, etc.); 7. Subjects who have used traditional Chinese medicine with cough-suppressing, expectorant, or bronchodilator effects within 2 weeks prior to enrollment; 8. Subjects who have participated in or are currently participating in other clinical drug trials within the past 3 months; 9. Subjects with a history of severe allergies or known hypersensitivity to any component of the investigational drug; 10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed; 11. Subjects with mental illness or cognitive impairment who are unable to understand or cooperate with routine diagnostic and treatment procedures and clinical examinations; 12. Other subjects deemed unsuitable for inclusion in the study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom reaches stable time; | — |
Secondary
| Measure | Time frame |
|---|---|
| mMRC Scale (modified Medical Research Council Dyspnea Scale, mMRC);TCM Syndrome Score;White blood cell count;Neutrophil count;lymphocyte count;monocyte count;Eosinophil count;Neutrophil Percentage;lymphocyte ratio;Overall C-reactive protein;Procalcitonin;Interleukin-4;Interleukin-6;Interleukin-10;Interleukin-12 p70;Interleukin-17;Interferon gamma;Tumor Necrosis Factor Alpha;First second forced expiratory volume;The percentage of the forced expiratory volume in the first second relative to the predicted value.;The ratio of forced expiratory volume in the first second to forced vital capacity.;Total hospitalization cost; | — |
Countries
China
Contacts
Public ContactChen Min
Guangdong Medical University Affiliated Hospital
Outcome results
None listed