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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
  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 10 mg
Drug: placebo
Drug: ginsenoside-Rd 20mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
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.
 Drug: ginsenoside-Rd 10 mg
infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days
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.
 Drug: placebo
infusion placebo (group B)once a day and continued for 14 days
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
 Drug: ginsenoside-Rd 20mg
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

No publications provided by Xijing Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: the neurology department of Xijing Hospital, Xijing Hospital
ClinicalTrials.gov Identifier: NCT00591084     History of Changes
Other Study ID Numbers: xijing-001
Study First Received: December 27, 2007
Last Updated: August 30, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
randomized trial
ischemic stroke
Ginsenoside-Rd

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 19, 2013