Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD：a Multicentre Randomised Controlled Trial
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.
A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD). ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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