NCT00815763

Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Multicenter Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	ginsenoside-Rd	infusion ginsenoside-Rd 20 mg once a day and continued for 14 day
DRUG	placebo	infusion placebo once a day and continued for 14 day

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-06-01
• Completion: 2008-09-01
• First posted: 2008-12-30
• Last updated: 2008-12-30

Locations

1 site across 1 country: China