Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

December 29, 2008 updated by: Xijing Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • The Department of Neurology , Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the modified Rankin scale
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
NIHSS scores
Time Frame: 8 days
8 days
NIHSS scores
Time Frame: 15 days
15 days
the Barthel index
Time Frame: 8 days
8 days
the Barthel index
Time Frame: 15 days
15 days
the modified Rankin scale
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Xuedong Liu, MD, The Department of Neurology, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 29, 2008

First Submitted That Met QC Criteria

December 29, 2008

First Posted (Estimate)

December 30, 2008

Study Record Updates

Last Update Posted (Estimate)

December 30, 2008

Last Update Submitted That Met QC Criteria

December 29, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xijing-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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