[Clinical study on effect of sanqi tongshu capsule in treating ischemic stroke: multicenter clinical trial].
OBJECTIVE
To observe the clinical effect and security of Sanqi Tongshu capsule in treating ischemic strkoe.


METHODS
A multicenter, no dummy, open labeled clincal trail was conducted. 1 753 patient were enrolled in this clinical trial. All patients were treated with the Sanqi Tongshu capsule (200 mg, three times a day) for 28 days. The score of Europe Stroke Score (ESS) and Barthel Index (BI) were evaluated before and after treatment. The adverse reaction occurred in the therapeutic course was also observed.


RESULTS
Finally, 1742 cases and 1676 cases were respectively assessable by Full analysis set (FAS) analysis and Full analysis set (FAS) analysis. Clinical symptoms markedly improved in patients after treatment, and the score of ESS and BI had significantly improved (P<0.05). According to the score of ESS and BI, the total effect analysis indicated that the total effective rate in FAS and PPS were 81.86% and 84.43% respectively. The rate of adverse reaction was 3.44%, and the raction was so slight that didn't need to receive therapy or withdral drug.


CONCLUSIONS
Sanqi Tongshu capsule is effect and secure in treating ischemic stroke without obvious adverse reaction.
Zhou
Dong
D
Neurology Department, West China Hospital of Sichnan University, Chengdu 610041, China. heli2003new@126.com
Hong
Zhen
Z
Wang
Yong-jun
YJ
Chi
Zhao-fu
ZF
Luo
Ben-yan
BY
Di
Qing
Q
Chen
Kang-min
KM
D000368:Aged; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D020521:Stroke / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
D004365:Drugs, Chinese Herbal