Study to Evaluate the Clinical Value and Safety of Xiyanping Injection in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD) Based on Real-world Clinical Data

NCT ID: NCT06754865

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-11-30

Brief Summary

The primary objective is to evaluate the effect of Xiyanping injection on the treatment course of intravenous antibiotics for acute exacerbation of chronic obstructive pulmonary disease based on real-world clinical data, and to provide guidance and basis for the clinical application of Xiyanping injection combined with antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease.The secondary objectives is to evaluate the effect of Xiyanping injection on the indicators of acute exacerbation of inflammation and symptom improvement of chronic obstructive pulmonary disease.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Exposure group

Xiyanping injection + Antimicrobial agents treatment

Xiyanping injection+ antibiotic

Intervention Type: DRUG

Xiyanping injection+ antibiotic

Non-exposure group

Antimicrobial agents treatment

Antibiotic

Intervention Type: DRUG

Antibiotic

Interventions

Xiyanping injection+ antibiotic

Xiyanping injection+ antibiotic

Intervention Type: DRUG

Antibiotic

Antibiotic

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Discharged with chronic obstructive pulmonary disease;

2. Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection;

3. The treatment course of Xiyanping injection in the exposed group was ≥3 days, and the non-exposed group did not use Xiyanping injection;

4. Study patients with complete medical records.

Exclusion Criteria

1. Researchers believe that multiple proprietary Chinese medicines with the same or similar functions (such as Tanreqing injection, Reduning injection, Yanhuning injection, etc.) have been used at the same time during treatment, resulting in no assessment of efficacy or safety;

2. Patients with viral pneumonia or other systemic infection (such as urinary tract infection);

3. Patients who do not use intravenous antibiotics;

4. Refuse the case to be used by researchers.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Role: CONTACT

010-62835646

Other Identifiers

2024XLA207-1

Identifier Type: -

Identifier Source: org_study_id