Ginsenoside-Rd for Acute Ischemic Stroke

NCT ID: NCT00591084

Last Updated: 2010-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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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

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ginsenoside-Rd 10mg

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.

Group Type EXPERIMENTAL

ginsenoside-Rd 10 mg

Intervention Type DRUG

infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days

placebo

2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

infusion placebo (group B)once a day and continued for 14 days

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

Group Type EXPERIMENTAL

ginsenoside-Rd 20mg

Intervention Type DRUG

infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days

Interventions

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ginsenoside-Rd 10 mg

infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days

Intervention Type DRUG

placebo

infusion placebo (group B)once a day and continued for 14 days

Intervention Type DRUG

ginsenoside-Rd 20mg

infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xijing Hospital

Principal Investigators

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Gang Zhao, MD

Role: STUDY_DIRECTOR

the Department of Neurology , Xijing Hospital;

Xuedong Liu, MD

Role: STUDY_CHAIR

the Department of Neurology, Xijing Hospital;

Locations

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the Department of Neurology , Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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Liu X, Xia J, Wang L, Song Y, Yang J, Yan Y, Ren H, Zhao G. Efficacy and safety of ginsenoside-Rd for acute ischaemic stroke: a randomized, double-blind, placebo-controlled, phase II multicenter trial. Eur J Neurol. 2009 May;16(5):569-75. doi: 10.1111/j.1468-1331.2009.02534.x. Epub 2009 Feb 19.

Reference Type DERIVED
PMID: 19236467 (View on PubMed)

Other Identifiers

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xijing-001

Identifier Type: -

Identifier Source: org_study_id

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