Back to results

Ginsenoside-Rd for Acute Ischemic Stroke

Primary Purpose

Ischemic Stroke

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

ginsenoside-Rd 10 mg

placebo

ginsenoside-Rd 20mg

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring randomized trial, ischemic stroke, Ginsenoside-Rd

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

the Department of Neurology , Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

ginsenoside-Rd 10mg

placebo

ginsenoside-Rd 20mg

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

NIHSS scores

Secondary Outcome Measures

NIHSS scores

the Barthel index

the modified Rankin scale

Full Information

NCT ID

NCT00591084

First Posted

December 27, 2007

Last Updated

August 30, 2010

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00591084

Brief Title

Ginsenoside-Rd for Acute Ischemic Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

randomized trial, ischemic stroke, Ginsenoside-Rd

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

199 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ginsenoside-Rd 10mg

Arm Type

Experimental

Arm Description

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.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

ginsenoside-Rd 20mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ginsenoside-Rd 10 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ginsenoside-Rd 20mg

Intervention Description

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

Primary Outcome Measure Information:

Title

NIHSS scores

Time Frame

15±1 days

Secondary Outcome Measure Information:

Title

NIHSS scores

Time Frame

8 days

Title

the Barthel index

Time Frame

8 days

Title

the Barthel index

Time Frame

15 days

Title

the modified Rankin scale

Time Frame

15 days

Title

the modified Rankin scale

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Zhao, MD

Organizational Affiliation

the Department of Neurology , Xijing Hospital;

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xuedong Liu, MD

Organizational Affiliation

the Department of Neurology, Xijing Hospital;

Official's Role

Study Chair

Facility Information:

Facility Name

the Department of Neurology , Xijing Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

19236467

Citation

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.

Results Reference

derived

Learn more about this trial

Ginsenoside-Rd for Acute Ischemic Stroke

We'll reach out to this number within 24 hrs