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Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815763
First Posted: December 30, 2008
Last Update Posted: December 30, 2008
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 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
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 3, Multicenter Trial

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • the modified Rankin scale [ Time Frame: 90 days ]

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

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
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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): 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

Responsible Party: the neurology department of Xijing Hospital, Xijing Hospital
ClinicalTrials.gov Identifier: NCT00815763     History of Changes
Other Study ID Numbers: xijing-002
First Submitted: December 29, 2008
First Posted: December 30, 2008
Last Update Posted: December 30, 2008
Last Verified: December 2008

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