A Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT ID: NCT06134063

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2025-03-31

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 basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment.

If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.

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 basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment.

If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Xuanfei Baidu granule

Intervention Type: DRUG

Xuanfei Baidu granule will be administered twice daily for 7 days on the basis of basic treatment

Control group

Group Type: PLACEBO_COMPARATOR

Xuanfei Baidu granule Placebo

Intervention Type: DRUG

Xuanfei Baidu granule Placebo will be administered twice daily for 7 days on the basis of basic treatment

Interventions

Xuanfei Baidu granule

Xuanfei Baidu granule will be administered twice daily for 7 days on the basis of basic treatment

Intervention Type: DRUG

Xuanfei Baidu granule Placebo

Xuanfei Baidu granule Placebo will be administered twice daily for 7 days on the basis of basic treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cuiling Feng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingli Feng

Role: CONTACT

20210941147@bucm.edu.cn

18810535368

Cuiling Feng

Role: CONTACT

fengcuiling@sina.com

15901341502

Facility Contacts

Cuiling Feng

Role: primary

fengcuiling@sina.com

15901341502

Other Identifiers

XFBD-AECOPD-001

Identifier Type: -

Identifier Source: org_study_id