Ginsenoside-Rd for Acute Ischemic Stroke

This study has been completed.

Sponsor:

Information provided by:

Xijing Hospital

ClinicalTrials.gov Identifier:

NCT00591084

First received: December 27, 2007

Last updated: August 30, 2010

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

December 27, 2007

Last Updated Date

August 30, 2010

Start Date ^ICMJE

September 2005

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

NIHSS scores [ Time Frame: 15±1 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00591084 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

NIHSS scores [ Time Frame: 8 days ] [ Designated as safety issue: No ]
the Barthel index [ Time Frame: 8 days ] [ Designated as safety issue: No ]
the Barthel index [ Time Frame: 15 days ] [ Designated as safety issue: No ]
the modified Rankin scale [ Time Frame: 15 days ] [ Designated as safety issue: No ]
the modified Rankin scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ginsenoside-Rd for Acute Ischemic Stroke

Official Title ^ICMJE

Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ, Multicenter Trial

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Ischemic Stroke

Intervention ^ICMJE

Drug: ginsenoside-Rd 10 mg
infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days
Drug: placebo
infusion placebo (group B)once a day and continued for 14 days
Drug: ginsenoside-Rd 20mg
infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days

Study Arm (s)

Experimental: 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.

Intervention: Drug: ginsenoside-Rd 10 mg
Placebo Comparator: placebo
2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed.

Intervention: Drug: placebo
Experimental: 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

Intervention: Drug: ginsenoside-Rd 20mg

Publications *

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. Epub 2009 Feb 19.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

199

Completion Date

September 2006

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00591084

Other Study ID Numbers ^ICMJE

xijing-001

Has Data Monitoring Committee

Yes

Responsible Party

the neurology department of Xijing Hospital, Xijing Hospital

Study Sponsor ^ICMJE

Xijing Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Gang Zhao, MD	the Department of Neurology , Xijing Hospital;
Study Chair:	Xuedong Liu, MD	the Department of Neurology, Xijing Hospital;

Information Provided By

Xijing Hospital

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top