Status:
UNKNOWN
A Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Peking University People's Hospital
Conditions:
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial. This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of ...
Detailed Description
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial. This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of ...
Eligibility Criteria
Inclusion
- Aged between 40 and 80 years old, including 40 and 80 years old, regardless of gender;
- Clinical records of traceable of the chronic obstructive pulmonary disease history records, after bronchodilator FEV1 less than 80% of the expected value;
- Comply with the definition of COPD acute exacerbations and with mild and moderate severity assessment;
- Symptoms of AECOPD time less than 48 h;
- "Shiduyufei" diagnostic standard;
- Volunteered for the study, signed informed consent, is willing to cooperate with the visitor.
Exclusion
- Patients showing signs of hospitalization;
- With respiratory system diseases other than the AECOPD (for example, pneumonia, bronchiectasis, active tuberculosis, pneumothorax, pleural effusion, pulmonary embolism, or affect the respiratory movement function of neuromuscular diseases, etc.);
- Patients with severe basic diseases (for example, uncontrolled hypertension diabetes and complicated with heart failure (NYHA class IV), severe arrhythmia, acute coronary syndrome, hemodynamic instability, long-term use of immunosuppressive agents, etc.);
- With primary disease such as tumor or blood system;
- With severe liver disease (cirrhosis, portal hypertension, varices bleeding) or renal insufficiency;
- Pregnant women and breastfeeding mothers, those suspected of being pregnant, or women of childbearing age at risk of pregnancy who have not taken effective contraceptive measures;
- Dementia, mental disorders, such as unable to read or understand the research content, the information collection;
- With drug allergy;
- 3 months prior to screening for other interventional clinical research and the research data information;
- Within 1 week before screening been oral Chinese medicine or other proprietary Chinese medicine treatment;
- Patient refused to sign a consent form, or estimate adherence is poor, or follow-up possibilities is poor.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT06134063
Start Date
November 1 2023
End Date
March 1 2025
Last Update
November 18 2023
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China