Ginsenoside-Rd for Acute Ischemic Stroke

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00591084

Enrollment

199

Registered

2008-01-11

Start date

2005-09-30

Completion date

2006-09-30

Last updated

2010-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

randomized trial, ischemic stroke, Ginsenoside-Rd

Brief summary

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

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
NIHSS scores	15±1 days

Secondary

Measure	Time frame
NIHSS scores	8 days
the Barthel index	8 days
the modified Rankin scale	15 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026