Ginsenoside-Rd improves outcome of acute ischaemic stroke - a randomized, double-blind, placebo-controlled, multicenter trial.
OBJECTIVE
Ginsenoside-Rd is a receptor-operated calcium channel antagonist and has shown promise as a neuroprotectant in our phase II study. As an extended work, we sought to confirm its efficacy and safety of Ginsenoside-Rd in patients with acute ischaemic stroke.


METHODS
We conducted a randomized, double-blind, placebo-controlled trial involving 390 patients with acute ischaemic stroke in a 3:1 ratio to receive a 14-day intravenous infusion of Ginsenoside-Rd or placebo within 72 h after the onset of stroke. Our primary end-point was the distribution of disability scores on the modified Rankin scale (mRs) at 90 days.


RESULTS
The efficacy analysis was based on 386 patients (Ginsenoside-Rd group: 290; placebo group: 96). Ginsenoside-Rd significantly improved the overall distribution of scores on the mRs, as compared with the placebo (P = 0.02; odds ratios [OR], 1.74; 95% confidence interval [CI], 1.08-2.78). There were significant differences between the two groups when we categorized the scores into 0-1 vs. 2-5 (P = 0.01; OR, 2.32; 95% CI, 1.23-4.38; 66.8% vs. 53.1%). It also improved the National Institutes of Health Stroke Scale (NIHSS) at 15 days [P < 0.01; least squares mean (LSM), -0.77; 95% CI, -1.31 to -0.24]. Mortality and rates of adverse events were similar in the two groups.


CONCLUSIONS
Ginsenoside-Rd improved the primary outcome of acute ischaemic stroke and had an acceptable adverse-event profile.
Department of Neurology, Xijing Hospital, Xi'an, China.
X
X
Liu
L
L
Wang
A
A
Wen
J
J
Yang
Y
Y
Yan
Y
Y
Song
X
X
Liu
H
H
Ren
Y
Y
Wu
Z
Z
Li
W
W
Chen
Y
Y
Xu
L
L
Li
J
J
Xia
G
G
Zhao
D000293:Adolescent; D000328:Adult; D000368:Aged; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D036145:Ginsenosides / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous / Q000379:methods; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D020521:Stroke / Q000000981:diagnostic imaging / Q000188:drug therapy*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
D036145:Ginsenosides; D018696:Neuroprotective Agents; C049863:ginsenoside Rd