Clinical study on effect of sanqi tongshu capsule in treating ischemic stroke: multicenter clinical trial.
- Author:
Dong ZHOU
1
;
Zhen HONG
;
Yong-jun WANG
;
Zhao-fu CHI
;
Ben-yan LUO
;
Qing DI
;
Kang-min CHEN
Author Information
- Publication Type:Clinical Trial
- MeSH: Aged; Drugs, Chinese Herbal; adverse effects; therapeutic use; Female; Humans; Male; Stroke; drug therapy; pathology; Treatment Outcome
- From: China Journal of Chinese Materia Medica 2008;33(22):2692-2696
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo observe the clinical effect and security of Sanqi Tongshu capsule in treating ischemic strkoe.
METHODA 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.
RESULTFinally, 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.
CONCLUSIONSanqi Tongshu capsule is effect and secure in treating ischemic stroke without obvious adverse reaction.
