Danhong Injection in the Treatment of Acute Ischemic Stroke

Recruiting

Phase 4 Results N/A

Trial Description

The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
    ARM 1: Kind: Experimental
    Label: placebo
    Description: Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
  • Standard Medical Care Procedure
    Intervention Desc: Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.
    ARM 1: Kind: Experimental
    Label: Danhong injection
    Description: Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
    ARM 2: Kind: Experimental
    Label: placebo
    Description: Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.
  • Danhong injection Drug
    Intervention Desc: A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower. 40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion
    ARM 1: Kind: Experimental
    Label: Danhong injection
    Description: Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale 0-1 (favourable outcome) at Day 90 Day 90 No
Secondary The Score of effect on symptoms of "Xueyue Zheng"(Blood Stasis syndrome) Day 0, Day7, Day 14, Day 30, Day 60, Day 90 No
Secondary Barthel Index score ≥90 Day 0, Day7, Day 14, Day 30, Day 60, Day 90 No
Secondary NIH stroke scale(NIHSS) Day 0, Day7, Day 14, Day 30, Day 60, Day 90 No
Secondary EQ-5D scale Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 No
Secondary Global disability on mRS at Day 90. Day 90 No
Secondary Incidence of new-onset major vascular events in 90 days Day 90 Yes
Secondary Overall mortality at day 90 Day 90 Yes
Secondary Incidence of severe hemorrhages in 90 days Day 90 Yes
Secondary Incidence of moderate hemorrhages in 90 days Day 90 Yes
Secondary Documentation of adverse events (AEs) and serious AEs 90 days Yes

Sponsors