Ginsenoside-Rd for Acute Ischemic Stroke

Phase 2

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: ginsenoside-Rd 10 mg; Drug: placebo; Drug: ginsenoside-Rd 20mg

• Registration Number: NCT00591084
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-06
• Study Completion: 2006-09
• Status Verified: 2007-12
• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Last Update Submitted: 2010-08-30
• Last Update Posted: 2010-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 10mg	ginsenoside-Rd 10 mg	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.
placebo	placebo	2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed.
ginsenoside-Rd 20mg	ginsenoside-Rd 20mg	2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed

Primary Outcome Measures

Name	Time	Method
NIHSS scores	15±1 days

Secondary Outcome Measures

Name	Time	Method
NIHSS scores	8 days
the Barthel index	15 days
the modified Rankin scale	90 days

Trial Locations

Locations (1)

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