| Objective: Exploring the clinical curative effect and safety of Xinmaitong capsule in treating stroke ( syndrome of Fengtanyuzu).Methods: Adopted randomization, double blindness, positive medicine control of equal rank, multi-central clinical trial method, in this trial selected 480 suitable cases whom were parted two groups at random , the ratio of treat groups to control groups was 3:1. The treat group took the Xinmaitong capsules,the control groups took the Xinnaoshutong capsules. The period of treatment is 28 days. Every patient, when they had taken the capsules for two weeks , they should com back making a observation of treatment. After four weeks, We observed the curative effect of stroke, record the symptoms'change and normal physiology, for the symptom and safety analysis.Results:Curative effect evaluation: After the trial there were 457 cases in intention-to-treat (ITT),456 cases in per-protocol population(PP). Curative effect valued by the PP crowd . In the treat groups ,showed better curative effect in treating stroke, the signs had changed much better than before took the capsules .The total effective percentage was 86.50%, the average effective percentage of syndrome of Fengtanyuzu was 85.04%. Higher then control group,there was significant diference between two groups (P<0.01). Single syndrome Curative effect evaluation: Curative effect of hemiplegia and one side of the body sensation unusual were diference between two group (P<0.05).Other single syndrome curative effec were no significant diference between two groups (P>0.05). Safety analysis: There were no untoward reactions in both treat group and control group in the clinical trial.Conclusion: In this multi-central clinical trial ,Xinmaitong capsule has a credible curative effect, safe and steady function with no side effect. It is a satisfied Chinese medicine in curing recovery phase of stroke (syndrome of Fengtanyuzu).
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