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

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

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.

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