NCT00815763

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
Last Updated

December 30, 2008

Status Verified

December 1, 2008

Enrollment Period

1.8 years

First QC Date

December 29, 2008

Last Update Submit

December 29, 2008

Conditions

Ischemic Stroke

Keywords

randomized trialischemic strokeGinsenoside-Rd

Outcome Measures

Primary Outcomes (1)

  • the modified Rankin scale

    90 days

Secondary Outcomes (5)

  • NIHSS scores

    8 days

  • NIHSS scores

    15 days

  • the Barthel index

    8 days

  • the Barthel index

    15 days

  • the modified Rankin scale

    15 days

Study Arms (2)

ginsenoside-Rd 20mg

EXPERIMENTAL

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

Drug: ginsenoside-Rd

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

ginsenoside-RdDRUG

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

ginsenoside-Rd 20mg
placeboDRUG

infusion placebo once a day and continued for 14 day

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 18 to 75 years
  • the first episode
  • from onset to admission within 72 hours
  • NIHSS scores:5\~22

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Department of Neurology , Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

ginsenoside Rd

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gang Zhao, MD

    the Department of Neurology , Xijing Hospital

    STUDY DIRECTOR

  • Xuedong Liu, MD

    the Department of Neurology, Xijing Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 30, 2008

Study Start

September 1, 2006

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

December 30, 2008

Record last verified: 2008-12

Locations

CN(1)