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Ginsenoside-Rd for Acute Ischemic Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00591084
First Posted: January 11, 2008
Last Update Posted: September 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Xijing Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • NIHSS scores [ Time Frame: 8 days ]
  • the Barthel index [ Time Frame: 8 days ]
  • the Barthel index [ Time Frame: 15 days ]
  • the modified Rankin scale [ Time Frame: 15 days ]
  • the modified Rankin scale [ Time Frame: 90 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 27, 2007
First Posted: January 11, 2008
Last Update Posted: September 1, 2010
Last Verified: December 2007

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

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