Acute exacerbation of COPD
Conditions
Interventions
Control Group: Basic therapy
Sponsors
Hunan integrated traditional Chinese and Western Medicine Hospital (Affiliated Hospital of Hunan Academy of traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) 40 = age = 85 gender unlimited; (2) Meet the diagnostic criteria of acute exacerbation of chronic obstructive pulmonary disease; (3) According to the 2024 gold guidelines the severity of COPD exacerbations was assessed as moderate to severe (moderate: treatment with sabds and oral corticosteroids ± antibiotics; Severe: patients need to be hospitalized or go to the emergency department) (4) Acute attack within 3 days; (5) The pulmonary function grade was between grade II and III (30% = FEV1 accounted for < 80% of the predicted value); (6) TCM syndrome differentiation belongs to phlegm heat obstructing lung syndrome; (7) Voluntarily participate in this clinical trial give informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with dry bronchiectasis with hemoptysis as the main manifestation; (2) Patients with high fever (greater than 39 degrees) massive hemoptysis or severe respiratory failure requiring ventilator treatment; (3) Complicated with other serious medical diseases such as malignant tumors serious heart liver and kidney diseases serious metabolic diseases etc; (4) Long term treatment with glucocorticoids or immunosuppressants; (5) Those who are not suitable for gastrointestinal administration; (6) Women during pregnancy lactation and pregnancy preparation; (7) Those who are allergic to the ingredients of this product; (8) The mental state cannot cooperate with the observer or cognitive impairment; (9) Those who have participated in other drug trials in the past 3 months; (10) The investigator believes that there are any other circumstances that are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspnea, Cough and Phlegm Scale (BCSS) score;Efficacy of disease:roportion of subjects whose disease reached the effective standard on the 7th day of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hormone and antibiotic usage (variety, dosage, duration);Pulmonary function test on the 7th day of medication: forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, and FEV1 to predicted value;Cough and expectoration Assessment Questionnaire (casa-q) on the 7th day of medication;Discharge rate on the 7th day;TCM syndrome score on the 3rd, 5th and 7th day of medication;Self assessment test (CAT) of patients with chronic obstructive pulmonary disease on the 7th day of medication;Peripheral blood inflammatory indicators on the 7th day of medication: white blood cell count (WBC), neutrophil proportion (NEUT%), eosinophil proportion (EOS%), C-reactive protein (CRP), procalcitonin (PCT);Length of hospital stay;Modified British Medical Research Council Dyspnea Questionnaire (MMRC) on the 7th day of medication;Arterial blood gas analysis on the 7th day of medication: pH, oxygenation index (pao2/fio2), partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2), blood oxygen saturation (SaO2); | — |
Countries
China
Contacts
Public ContactTan Guangbo/Yuan Chunyun
Hunan integrated traditional Chinese and Western Medicine Hospital (Affiliated Hospital of Hunan Academy of traditional Chinese Medicine)
Outcome results
None listed