Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke

Air Force Military Medical University of People's Liberation Army

Status and phase

Completed

Phase 3

Conditions

Ischemic Stroke

Treatments

Drug: ginsenoside-Rd

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00815763

xijing-002

Details and patient eligibility

About

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

Full 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.

Enrollment

390 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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