Back to resultsEfficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ginsenoside-Rd
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring randomized trial, ischemic stroke, Ginsenoside-Rd
Eligibility 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
Sites / Locations
- the Department of Neurology , Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ginsenoside-Rd 20mg
placebo
Arm Description
infusion of ginsenoside-Rd 20mg once a day and continued for 14 days
infusion placebo (group B)once a day and continued for 14 days
Outcomes
Primary Outcome Measures
the modified Rankin scale
Secondary Outcome Measures
NIHSS scores
NIHSS scores
the Barthel index
the Barthel index
the modified Rankin scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00815763
Brief Title
Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke
Official Title
Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
randomized trial, ischemic stroke, Ginsenoside-Rd
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ginsenoside-Rd 20mg
Arm Type
Experimental
Arm Description
infusion of ginsenoside-Rd 20mg once a day and continued for 14 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
infusion placebo (group B)once a day and continued for 14 days
Intervention Type
Drug
Intervention Name(s)
ginsenoside-Rd
Intervention Description
infusion ginsenoside-Rd 20 mg once a day and continued for 14 day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
infusion placebo once a day and continued for 14 day
Primary Outcome Measure Information:
Title
the modified Rankin scale
Time Frame
90 days
Secondary Outcome Measure Information:
Title
NIHSS scores
Time Frame
8 days
Title
NIHSS scores
Time Frame
15 days
Title
the Barthel index
Time Frame
8 days
Title
the Barthel index
Time Frame
15 days
Title
the modified Rankin scale
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Zhao, MD
Organizational Affiliation
the Department of Neurology , Xijing Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xuedong Liu, MD
Organizational Affiliation
the Department of Neurology, Xijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
the Department of Neurology , Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke
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