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Efficacy and safety of bergenin tablet for patients with acute exacerbation of chronic obstructive pulmonary disease: study protocol for a double-blind, parallel-group randomized controlled trial

Efficacy and safety of bergenin tablet for patients with acute exacerbation of chronic obstructive pulmonary disease: study protocol for a double-blind, parallel-group randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055712
Enrollment
Unknown
Registered
2022-01-16
Start date
2021-08-24
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute exacerbation of chronic obstructive pulmonary disease

Interventions

experimental group:bergenin tablet
control group:Placebo

Sponsors

Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female aged >= 40 years; 2. Patients that meet the AECOPD diagnostic criteria; 3. Signed and dated written informed consent obtained prior to participation.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with asthma. 2. Complicated with Other respiratory diseases, such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans. 3. Previous pneumonectomy. 4. Patients with thoracic deformity, pneumothorax, rib fracture, unstable cardiac function (such as recent myocardial infarction, unstable angina) or unstable vital signs. 5. Clinically significant abnormalities shown on chest X-ray or computed tomography scan (if abnormalities were not due to COPD). 6. Abnormal kidney function (serum creatinine >= 2mg/dl or >= 177µmol/l) or abnormal liver function (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 100U/L). 7. Patients require mechanical ventilation (meeting at least one of the following indications: arterial pH<= 7.25; severe dyspnea and respiratory muscle fatigue or increased work of breathing (use of accessory respiratory muscles, paradoxic abdominal movement, or retraction of intercostal?muscles); heart rate < 50 beats/min and unresponsive; consciousness disorder. 8. Mental disorders. 9. Use antihistamines within 3 days before enrollment. 10. History of allergic diseases. 11. Pregnant and lactating women. 12. Participants who are currently participating in other clinical trials within three months. 13. Antibiotics and expectorants were used 1 day before hospitalization.

Design outcomes

Primary

MeasureTime frame
COPD Assessment Test (CAT) score;

Secondary

MeasureTime frame
Inflammation indicators;Lung function;Clinical symptoms of dyspnea and cough;Length of hospitalization;

Countries

China

Contacts

Public ContactDong Wu

Affiliated Hospital of Guangdong Medical University

wudong98@126.com+86 18476046478

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026