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Not yet recruiting NCT06754865

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

— Observational Acute Exacerbation of Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xiyanping injection+ antibiotic, Antibiotic.
Who it may be relevant to
Registry conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Muulticenter, Open, Non-interventional, Retrospective Cohort 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

Overview

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.

Interventions

  • Drug Xiyanping injection+ antibiotic
    Xiyanping injection+ antibiotic
  • Drug Antibiotic
    Antibiotic

Primary outcome measures

  • Course of intravenous antibiotics [Time frame: baseline, at 3(±1), 7(±1), and 10 days during medication]

Eligibility criteria

Inclusion criteria

  • Discharged with chronic obstructive pulmonary disease;
  • Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection;
  • The treatment course of Xiyanping injection in the exposed group was ≥3 days, and the non-exposed group did not use Xiyanping injection;
  • Study patients with complete medical records.

Exclusion criteria

  • 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;
  • Patients with viral pneumonia or other systemic infection (such as urinary tract infection);
  • Patients who do not use intravenous antibiotics;
  • Refuse the case to be used by researchers.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06754865 · 2024XLA207-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗