Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

Completed

Phase 3 Results N/A

Trial Description

The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.

Detailed Description

A phase Ⅲ randomized, double-blind, placebo-controlled, multicenter study was conducted to examine the efficacy and safety of ginsenoside-Rd in patients with acute ischemic stroke. Stroke patients were randomized equally to receive a 14-day infusion of placebo or ginsenoside-Rd 20mg. Primary end points were NIHSS scores at 15 days. Secondary end points were NIHSS scores and the Barthel index at 8 days, the Barthel index and the modified Rankin scale at 15 days and 90 days. The safety end points included serious and nonserious adverse events, laboratory values and vital signs. Analysis was by intention to treat.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: infusion placebo once a day and continued for 14 day
    ARM 1: Kind: Experimental
    Label: placebo
    Description: infusion placebo (group B)once a day and continued for 14 days
  • Ginsenoside-Rd Drug
    Other Names: ginsenoside-Rd
    Intervention Desc: infusion ginsenoside-Rd 20 mg once a day and continued for 14 day
    ARM 1: Kind: Experimental
    Label: ginsenoside-Rd 20mg
    Description: infusion of ginsenoside-Rd 20mg once a day and continued for 14 days

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 the modified Rankin scale 90 days No
Secondary NIHSS scores 8 days No
Secondary the Barthel index 8 days No

Sponsors