Skip to main content
OpenTrials
Completed

NCT Number: NCT00591084

Ginsenoside-Rd for Acute Ischemic Stroke

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

the Department of Neurology , Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ginsenoside-Rd 10 mg

Drug

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

Placebo

Drug

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

ginsenoside-Rd 20mg

Drug

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

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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 11, 2008
Registry last updated
Sep 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.