Objectives

This study aimed to investigate the safety and therapeutic efficacy of herbal drug, Di Huang Yin Zi (DHYZ), in patients affected by ischemic stroke.

Methods

In this double blind, placebo-controlled study, a total of 100 patients with recent (less than 30 days) ischemic stroke were randomized to receive DHYZ or placebo for 12 weeks. Both groups also received rehabilitation therapy during the study period. As there were 13 dropouts, a total of 45 patients on DHYZ and 42 on placebo were available for analysis. The Fugl-Meyer Assessment (FMA) and Barthel index (BI) were assessed before treatment and at 4-week intervals.

Results

We observed that the FMA score and BI were increased, in both groups at week 4, 8 and 12 compared with the baseline. Furthermore, significantly better FMA score was observed in patients treated with DHYZ at week 8 and 12 (both P<0.05). BI was significantly higher in DHYZ group than in placebo group at weeks 12 (P<0.05). At week 12, the 95% Confidence Intervals (CI) of mean difference of FMA and BI also indicated that the differences between two groups were statistically significant. Compared to placebo, DHYZ produced significantly greater improvement in FMA grade at week 12 (44.4% versus 23.8%, χ(2)=4.09, P<0.05).

Conclusions

DHYZ showed good efficacy, safety and tolerability in patients affected by ischemic stroke. We conclude that DHYZ may be a useful therapeutic option in patients with ischemic stroke.