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CompletedNCT00591084Updated Sep 1, 2010

Ginsenoside-Rd for Acute Ischemic Stroke

A Phase 2 interventional study of ginsenoside-Rd 10 mg and placebo in Ischemic Stroke, sponsored by Xijing Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-09-01.

Sponsored by Xijing Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
199
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • randomized trial
  • ischemic stroke
  • Ginsenoside-Rd
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 199 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
199 participants (actual)

Study arms

  • Experimental
    ginsenoside-Rd 10mg

    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

  • Placebo comparator
    placebo

    2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed.

    Drug: placebo

  • Experimental
    ginsenoside-Rd 20mg

    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

Interventions

  • Drugginsenoside-Rd 10 mg

    infusion ginsenoside-Rd 10 mg (group A)once a day and continued for 14 days

  • Drugplacebo

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

  • Drugginsenoside-Rd 20mg

    infusion of ginsenoside-Rd 20mg (group C) once a day and continued for 14 days

06

What researchers measure

Primary outcomes

  1. NIHSS scores

    Time frame: 15±1 days

Secondary outcomes

  1. NIHSS scores

    Time frame: 8 days

  2. the Barthel index

    Time frame: 8 days

  3. the Barthel index

    Time frame: 15 days

  4. the modified Rankin scale

    Time frame: 15 days

  5. the modified Rankin scale

    Time frame: 90 days

07

Study locations

1 site
  • the Department of Neurology , Xijing Hospital
    Xi'an, Shaanxi 710032, China
08

References and documents

Publications

  • Liu X, Xia J, Wang L, Song Y, Yang J, Yan Y, Ren H, Zhao G. Efficacy and safety of ginsenoside-Rd for acute ischaemic stroke: a randomized, double-blind, placebo-controlled, phase II multicenter trial. Eur J Neurol. 2009 May;16(5):569-75. doi: 10.1111/j.1468-1331.2009.02534.x. Epub 2009 Feb 19. PubMed 19236467 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00591084
Lead sponsor
Xijing Hospital
First posted
Jan 11, 2008
Start date
Sep 2005
Primary completion
Jun 2006
Completion
Sep 2006
Last update
Sep 1, 2010

Study contacts

Gang Zhao, MD
study director · the Department of Neurology , Xijing Hospital;
Xuedong Liu, MD
study chair · the Department of Neurology, Xijing Hospital;

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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