A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.

Enrolling by invitation

Phase 2 Results N/A

Trial Description

The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

Detailed Description

After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

Conditions

Interventions

  • Ginkgo diterpene lactone meglumine injection Drug
    Other Names: YinxingErtieneizhiPu'an Zhusheye
    Intervention Desc: 5 ml,oral,5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.
    ARM 1: Kind: Experimental
    Label: ginkgo diterpene lactone meglumine injection
    Description: ginkgo diterpene lactone meglumine injection
  • Ginkgo diterpene lactone meglumine injection simulation Drug
    Intervention Desc: 5 ml,oral,5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.
    ARM 1: Kind: Experimental
    Label: Ginkgo diterpene lactone meglumine injection simulation
    Description: Ginkgo diterpene lactone meglumine injection simulation

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 Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 . 90 days No
Secondary Proportion of patients with National Institutes of Health Stroke Score (NIHSS) rising 4 or more points, three points, two points, one of the subjects changes from baseline to randomized 7 days. Baseline, 7days No
Secondary Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reducing 4 points or more changes from baseline to randomized 7 days,14 days. Baseline,7 days,14 days, No
Secondary Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 . 90 days No
Secondary The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days. Baseline,14 days,90 days No
Secondary The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days. Baseline,14 days,90 days No
Secondary The all-cause mortality 90 days No
Secondary Ischemic stroke recurrence rate 90 days No
Secondary Composite incidence of vascular events 90 days No
Secondary The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days. Baseline,14 days,90 days No

Sponsors