Ginsenoside-Rd for Acute Ischemic Stroke

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

Detailed Description
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A major contributor to brain injury after stroke is disordered inward flow of Ca2+ and its toxic accumulation in the nervous system following cerebral ischemia. Ginsenoside-Rd, a purified component from total saponins of Panax notoginseng, has a molecular formula of C48H82O18•3H2O with a molecular weight of 1001.2. Ginsenoside-Rd has been shown to inhibit receptor-operated Ca2+ influx through receptor-and-store-operated Ca2+ channels (ROCC) , attenuate oxidative stress in stroke, reduce the size of the cerebral infarction and preserve brain functioning in animal models of acute ischemic stroke.

Official Title
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Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ, Multicenter Trial

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: ginsenoside-Rd 10 mg
* Drug: placebo
* Drug: ginsenoside-Rd 20mg


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 10mg<br>both a ginsenoside-Rd injection (10mg/1ml/each) and a specific dilution (10%, 1ml trimethylene glycol) were respectively diluted by a specific dilution (10%, 9 ml trimethylene glycol) and then mixed. | Drug: ginsenoside-Rd 10 mg<br>* infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days<br>|
| Placebo Comparator: placebo<br>2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed. | Drug: placebo<br>* infusion placebo (group B)once a day and continued for 14 days<br>|
| Experimental: ginsenoside-Rd 20mg<br>2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed | Drug: ginsenoside-Rd 20mg<br>* infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS scores |  | 15±1 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS scores |  | 8 days | 
| the Barthel index |  | 8 days | 
| the Barthel index |  | 15 days | 
| the modified Rankin scale |  | 15 days | 
| the modified Rankin scale |  | 90 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