Ginsenoside-Rd for Acute Ischemic Stroke

Completed

Phase 2 Results N/A

Trial Description

The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.

Detailed Description

A major contributor to brain injury after stroke is disordered inward flow of Ca2+ and its toxic accumulation in the nervous system following cerebral ischemia. Ginsenoside-Rd, a purified component from total saponins of Panax notoginseng, has a molecular formula of C48H82O18•3H2O with a molecular weight of 1001.2. Ginsenoside-Rd has been shown to inhibit receptor-operated Ca2+ influx through receptor-and-store-operated Ca2+ channels (ROCC) , attenuate oxidative stress in stroke, reduce the size of the cerebral infarction and preserve brain functioning in animal models of acute ischemic stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: infusion placebo (group B)once a day and continued for 14 days
    ARM 1: Kind: Experimental
    Label: placebo
    Description: 2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed.
  • Ginsenoside-Rd 10 mg Drug
    Intervention Desc: infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days
    ARM 1: Kind: Experimental
    Label: ginsenoside-Rd 10mg
    Description: both a ginsenoside-Rd injection (10mg/1ml/each) and a specific dilution (10%, 1ml trimethylene glycol) were respectively diluted by a specific dilution (10%, 9 ml trimethylene glycol) and then mixed.
  • Ginsenoside-Rd 20mg Drug
    Intervention Desc: infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days
    ARM 1: Kind: Experimental
    Label: ginsenoside-Rd 20mg
    Description: 2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary NIHSS scores 15±1 days No
Secondary the Barthel index 8 days No
Secondary the modified Rankin scale 15 days No

Sponsors