Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00815763

Enrollment

390

Registered

2008-12-30

Start date

2006-09-30

Completion date

2008-09-30

Last updated

2008-12-30

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

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.

Interventions

DRUGginsenoside-Rd

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

DRUGplacebo

infusion placebo once a day and continued for 14 day

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
the modified Rankin scale	90 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