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Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

NCT ID: NCT00815763

Last Updated: 2008-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-09-30

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.

Conditions

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Ischemic Stroke

Keywords

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randomized trial ischemic stroke Ginsenoside-Rd

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ginsenoside-Rd 20mg

infusion of ginsenoside-Rd 20mg once a day and continued for 14 days

Group Type EXPERIMENTAL

ginsenoside-Rd

Intervention Type DRUG

infusion ginsenoside-Rd 20 mg once a day and continued for 14 day

placebo

infusion placebo (group B)once a day and continued for 14 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

infusion placebo once a day and continued for 14 day

Interventions

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ginsenoside-Rd

infusion ginsenoside-Rd 20 mg once a day and continued for 14 day

Intervention Type DRUG

placebo

infusion placebo once a day and continued for 14 day

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xijing Hospital

Principal Investigators

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Gang Zhao, MD

Role: STUDY_DIRECTOR

the Department of Neurology , Xijing Hospital

Xuedong Liu, MD

Role: STUDY_CHAIR

the Department of Neurology, Xijing Hospital

Locations

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the Department of Neurology , Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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xijing-002

Identifier Type: -

Identifier Source: org_study_id