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.
- Placebo Drug
Intervention Desc: infusion placebo once a day and continued for 14 day ARM 1: Kind: Experimental Label: placebo Description: infusion placebo (group B)once a day and continued for 14 days
- Ginsenoside-Rd Drug
Other Names: ginsenoside-Rd Intervention Desc: infusion ginsenoside-Rd 20 mg once a day and continued for 14 day ARM 1: Kind: Experimental Label: ginsenoside-Rd 20mg Description: infusion of ginsenoside-Rd 20mg once a day and continued for 14 days
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||the modified Rankin scale||90 days||No|
|Secondary||NIHSS scores||8 days||No|
|Secondary||the Barthel index||8 days||No|
- Xijing Hospital Lead