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

Not yet recruiting

• Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Xiyanping injection+ antibiotic; Drug: Antibiotic

• Registration Number: NCT06754865
• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1140

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposure group	Xiyanping injection+ antibiotic	Xiyanping injection + Antimicrobial agents treatment
Non-exposure group	Antibiotic	Antimicrobial agents treatment

Primary Outcome Measures

Name	Time	Method
Course of intravenous antibiotics	baseline, at 3(±1), 7(±1), and 10 days during medication	Duration of intravenous antibiotic use