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Evaluation of Clinical Value and Safety of Xiyanping Injection in Treating Acute Exacerbation of Chronic Obstructive Pulmonary Disease Based on Real World Clinical Data

Evaluation of Clinical Value and Safety of Xiyanping Injection in Treating Acute Exacerbation of Chronic Obstructive Pulmonary Disease Based on Real World Clinical Data

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094567
Enrollment
Unknown
Registered
2024-12-24
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Exposome group:None
Non-exposed group:None

Sponsors

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnostic criteria: The relevant standards of the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2013 Revised Edition)" and the "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (2017 Updated Edition)" are adopted as follows: Diagnostic criteria for COPD: The diagnosis of COPD should be based on clinical presentation, history of exposure to risk factors, signs, and laboratory tests, and the exclusion of other conditions that can cause similar symptoms and persistent airflow limitation. The diagnosis of COPD should be considered clinically in any patient with dyspnea, chronic cough or sputum production, and a history of exposure to risk factors. Diagnostic criteria for AECOPD: The clinical course of acute onset of the patient, characterized by an acute exacerbation of respiratory symptoms, beyond the usual variants, and consequently the need to change their drug therapy. Typical manifestations are: worsening dyspnea, worsening cough, increased sputum volume, changes in sputum color and/or viscosity, fever, etc., and non-specific symptoms such as general malaise, insomnia, drowsiness, fatigue, depression, and mental disorders can also occur. 1. Diagnosed with chronic obstructive pulmonary disease after discharge; 2. Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection; 3. Those who used Xiyanping injection in the exposed group for >= 3 days, and those who did not use Xiyanping in the non-exposed group Injectors; 4. Those who have complete medical records.

Exclusion criteria

Exclusion criteria: 1. In the opinion of the investigators, during the treatment period, it is impossible to evaluate the efficacy or safety of patients who have used multiple proprietary Chinese medicines with the same or similar functions (such as Sputum Reqing Injection, Retoning Injection, Yan Huning Injection, etc.); 2 patients with viral pneumonia or other systemic infections (such as urinary tract infections); 3. Patients who have not used intravenous antibiotics; 4. Refuse to use the case for researchers.

Design outcomes

Primary

MeasureTime frame
The disappearance time of fever, expectoration (sputum quantity and color), cough and fatigue;

Secondary

MeasureTime frame
Inflammation-related indicators(If any);Course of intravenous antibiotics;adverse event;

Countries

China

Contacts

Public ContactMiao Qing

Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine

miaoqing55@sina.com+86 139 1081 2309

Outcome results

None listed

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