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Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

NCT02937974 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2016-10-19

No results posted yet for this study

Summary

Objective: A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).

Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They will be randomly assigned to Experimental group and Placebo group，Experimental: Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days；Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days. Compare the following index between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α，IFN-γ, APACHEⅡ, CAPS score.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Xuebijing

Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days

DRUG

Placebo

Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days

Sponsors & Collaborators

  • First Hospitals affiliated to the China PLA General Hospital

    collaborator OTHER_GOV

  • Navy General Hospital, Beijing

    collaborator OTHER

  • Rocket Force General Hospital，Chinese People's Liberation Army

    collaborator UNKNOWN

  • 307 Hospital of PLA

    collaborator OTHER

  • Beijing Shijitan Hospital, Capital Medical University

    collaborator OTHER

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Lixin Xie, Professor · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02937974 on ClinicalTrials.gov