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Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT00815763
Recruitment Status : Completed
First Posted : December 30, 2008
Last Update Posted : December 30, 2008
Sponsor:
Information provided by:
Xijing Hospital

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

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: ginsenoside-Rd Drug: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. NIHSS scores [ Time Frame: 8 days ]
  2. NIHSS scores [ Time Frame: 15 days ]
  3. the Barthel index [ Time Frame: 8 days ]
  4. the Barthel index [ Time Frame: 15 days ]
  5. the modified Rankin scale [ Time Frame: 15 days ]


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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

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

Responsible Party: the neurology department of Xijing Hospital, Xijing Hospital
ClinicalTrials.gov Identifier: NCT00815763     History of Changes
Other Study ID Numbers: xijing-002
First Posted: December 30, 2008    Key Record Dates
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