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Ginsenoside-Rd for Acute Ischemic Stroke

This study has been completed.
Information provided by:
Xijing Hospital Identifier:
First received: December 27, 2007
Last updated: August 30, 2010
Last verified: December 2007
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 Blind (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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00591084

China, Shaanxi
the Department of Neurology , Xijing Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
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 Identifier (NCT Number):
Responsible Party: the neurology department of Xijing Hospital, Xijing Hospital Identifier: NCT00591084     History of Changes
Other Study ID Numbers: xijing-001
Study First Received: December 27, 2007
Last Updated: August 30, 2010

Keywords provided by Xijing Hospital:
randomized trial
ischemic stroke

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia processed this record on May 25, 2017