Phase ‚Ö°Study of Pinocembrin Injection to Treat Ischemic Stroke

Suspended

Phase 2 Results N/A

Trial Description

This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.

Detailed Description

Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.

Conditions

Interventions

  • Pinocembrin for Injection Drug
    Other Names: DL0108
    ARM 1: Kind: Experimental
    Label: Pinocembrin for Injection
    Description: 40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
    ARM 2: Kind: Experimental
    Label: placebo
    Description: 60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days 90 days No
Secondary To compare treatment arms in terms of change from baseline to endpoint in NIHSS score. 90 days No

Sponsors