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Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00815763
First received: December 29, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted

December 29, 2008
December 29, 2008
September 2006
June 2008   (final data collection date for primary outcome measure)
the modified Rankin scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • NIHSS scores [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • NIHSS scores [ Time Frame: 15 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke
Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Multicenter Trial

The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.

A phase Ⅲ randomized, double-blind, placebo-controlled, multicenter study was conducted to examine the efficacy and safety of ginsenoside-Rd in patients with acute ischemic stroke. Stroke patients were randomized equally to receive a 14-day infusion of placebo or ginsenoside-Rd 20mg. Primary end points were NIHSS scores at 15 days. Secondary end points were NIHSS scores and the Barthel index at 8 days, the Barthel index and the modified Rankin scale at 15 days and 90 days. The safety end points included serious and nonserious adverse events, laboratory values and vital signs. Analysis was by intention to treat.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: ginsenoside-Rd
    infusion ginsenoside-Rd 20 mg once a day and continued for 14 day
    Other Name: ginsenoside-Rd
  • Drug: placebo
    infusion placebo once a day and continued for 14 day
    Other Name: placebo
  • Experimental: ginsenoside-Rd 20mg
    infusion of ginsenoside-Rd 20mg once a day and continued for 14 days
    Intervention: Drug: ginsenoside-Rd
  • Placebo Comparator: placebo
    infusion placebo (group B)once a day and continued for 14 days
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
September 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00815763
xijing-002
Yes
the neurology department of Xijing Hospital, Xijing Hospital
Xijing Hospital
Not Provided
Study Director: Gang Zhao, MD the Department of Neurology , Xijing Hospital
Study Chair: Xuedong Liu, MD the Department of Neurology, Xijing Hospital
Xijing Hospital
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP