Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

Phase 3

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: ginsenoside-Rd; Drug: placebo

• Registration Number: NCT00815763
• Lead Sponsor: Xijing Hospital

Brief 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.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2008-06
• Study Completion: 2008-09
• Status Verified: 2008-12
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2008-12-29
• Last Update Submitted: 2008-12-29
• Study First Posted: 2008-12-30
• Last Update Posted: 2008-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

• between 18 to 75 years
• the first episode
• from onset to admission within 72 hours
• NIHSS scores:5~22

Exclusion Criteria

• had other intracranial pathologies (e.g., tumor, infection)
• had a neurologic or psychiatric disease
• had a coexisting condition that limited their life expectancy
• had significant drug or alcohol misuse
• had high-grade carotid artery stenosis for which surgery was planned
• were pregnant or nursing
• participated in a clinical trial with an investigational drug or device within the past 3 months
• were unlikely to be available for follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ginsenoside-Rd 20mg	ginsenoside-Rd	infusion of ginsenoside-Rd 20mg once a day and continued for 14 days
placebo	placebo	infusion placebo (group B)once a day and continued for 14 days

Primary Outcome Measures

Name	Time	Method
the modified Rankin scale	90 days

Secondary Outcome Measures

Name	Time	Method
NIHSS scores	15 days
the Barthel index	15 days
the modified Rankin scale	15 days

Trial Locations

Locations (1)

the Department of Neurology , Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China