Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

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

Detailed Description
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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.

Official Title
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Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Multicenter Trial

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: ginsenoside-Rd
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ginsenoside-Rd 20mg<br>infusion of ginsenoside-Rd 20mg once a day and continued for 14 days | Drug: ginsenoside-Rd<br>* infusion ginsenoside-Rd 20 mg once a day and continued for 14 day<br>|
| Placebo Comparator: placebo<br>infusion placebo (group B)once a day and continued for 14 days | Drug: placebo<br>* infusion placebo once a day and continued for 14 day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the modified Rankin scale |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS scores |  | 8 days | 
| NIHSS scores |  | 15 days | 
| the Barthel index |  | 8 days | 
| the Barthel index |  | 15 days | 
| the modified Rankin scale |  | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized trial, ischemic stroke, Ginsenoside-Rd