Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Chinese PLA General Hospital
Collaborators:
307 Hospital of PLA Beijing Shijitan Hospital Beijing Shijitan Hospital, Capital Medical University First Hospitals affiliated to the China PLA General Hospital Navy General Hospital，Chinese People's Liberation Army Rocket Force General Hospital，Chinese People's Liberation Army