Acute exacerbation of chronic obstructive pulmonary disease
Conditions
Interventions
Bergenin tablet group:Regular treatment+Bergenin tablet (oral, one tablet three times per day)
Placebo group:Regular treatment+Placebo (oral, one tablet three times per day)
Sponsors
Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged between 40 and 80 years inclusive; 2. Patients that meet the AECOPD diagnostic criteria; 3. Signed and dated written informed consent obtained prior to participation.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women; 2. Allergic to bergenin; 3. Mental disorders; 4. Current respiratory disorders other than COPD (e.g., active pulmonary tuberculosis, asthma, cystic pulmonary fibrosis, pulmonary sarcoidosis, pulmonary interstitial fibrosis, severe bronchiectasis, pneumothorax, pleural effusion, pulmonary thromboembolism); 5. Condition complicated by shock, diffuse intravascular coagulation, acute myocardial infarction, upper gastrointestinal bleeding, severe heart failure (New York Heart Association Class IV), severe liver and kidney dysfunction (sequential organ failure assessment liver or kidney score =3), cancer, blood disease, Alzheimers disease; 6. Need for invasive mechanical ventilation (persistent or worsening hypoxemia (partial arterial oxygen pressure, 8.0 kPa, 60 mmHg), and/or severe/worsening of respiratory acidosis (pH <7.25) despite oxygen supplementation and noninvasive ventilation; inability to tolerate noninvasive mechanical ventilation; respiratory or cardiac arrest; respiratory pauses with loss of consciousness; reduced consciousness; heart rate <50 bpm with loss of alertness; severe hemodynamic instability without response to fluids and vasoactive drugs; severe ventricular arrhythmias); 7. Participants who are currently participating in any clinical studies in which investigational drugs are tested within 4 weeks prior to Visit 1 (baseline); 8. Patients unsuitable for participation in this trial according to the judgment of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| COPD Assessment Test (CAT) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Arterial blood gas analysis results;Changes in immune status indicators;Changes in inflammation indicators;Lung function;Readmission rate;Changes in the clinical symptoms of dyspnea and cough;Length and cost of hospitalization;Treatment failure rate;Incidence of complications; | — |
Countries
China
Contacts
Public ContactDong Wu
Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Guangdong Medical University
Outcome results
None listed