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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
  Purpose

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


Condition Intervention Phase
Ischemic Stroke
 Drug: ginsenoside-Rd
Drug: placebo
 Phase 3

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 3, Multicenter Trial

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • the modified Rankin scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 390
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ginsenoside-Rd 20mg
infusion of ginsenoside-Rd 20mg once a day and continued for 14 days
 Drug: ginsenoside-Rd
infusion ginsenoside-Rd 20 mg once a day and continued for 14 day
Other Name: ginsenoside-Rd
Placebo Comparator: placebo
infusion placebo (group B)once a day and continued for 14 days
 Drug: placebo
infusion placebo once a day and continued for 14 day
Other Name: placebo

Detailed Description:

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.

  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: NCT00815763

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

Responsible Party: the neurology department of Xijing Hospital, Xijing Hospital
ClinicalTrials.gov Identifier: NCT00815763     History of Changes
Other Study ID Numbers: xijing-002
Study First Received: December 29, 2008
Last Updated: December 29, 2008
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 16, 2013