Ginsenoside-Rd for Acute Ischemic Stroke - Full Text View

Sponsored by:	Xijing Hospital
Information provided by:	Xijing Hospital
ClinicalTrials.gov Identifier:	NCT00591084

Purpose

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

Condition	Intervention	Phase
Ischemic Stroke	Drug: ginsenoside-Rd Drug: placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ, Multicenter Trial

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	199
Study Start Date:	September 2005
Study Completion Date:	September 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591084

Locations

China, Shaanxi
the Department of Neurology , Xijing Hospital
Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Xijing Hospital

Investigators

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

More Information

Responsible Party:	Xijing Hospital ( the neurology department of Xijing Hospital )
Study ID Numbers:	xijing-001, neurology 006001
Study First Received:	December 27, 2007
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00591084
Health Authority:	China: State Food and Drug Administration

Keywords provided by Xijing Hospital:

randomized trial
ischemic stroke
Ginsenoside-Rd

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases

Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009