[Clinical study of super crush-run Tongxinluo capsule on treatment of stroke].

OBJECTIVE

To evaluate the clinical efficacy and security of super crush-run tong xinluo capsule (SCTXLC) for apoplexy due to energy-deficiency and blood-stasis.

METHOD

The randomised controlled double blind non-inferiority trial versus paroxetine, parallel contrast, different Kinds of Techniques and dosage, the clinical trial design was adopted, 144 patients with stroke of convalescent stage were selected by 2 group, which course of diseases was in 2 weekens to 3 months, neurological deficit scores was 8 to 30, grade of acaties of daily living scores was 2 to 5. the treatment group (n = 72) received SCTXLC 0.26 g (a capsule), 4 capsules at a time, three times a day, while that of the control group (n = 72) received common crush-run tong xinluo capsule (CCTXLC) 0.38 g (a capsule), 4 capsules at a time, three times a day, the therapeutic course for both groups was 28 d.

RESULT

The synthesis total effective rates of the stroke in treatment group and control group were 91.3% and 87.3% respectively, showing no significant difference. The Lower Bound Upper Bound of Asymptotic 95% Confidence Interval of the total effective rates difference is -4.57%, over the beforehand Lower Bound of 15%, non-inferiority trial versus paroxetine was eligible. The adverse reactions occurred was 1 patient in the treatment group and 2 patients in control group in clinical trial.

CONCLUSION

SCTXLC has definite effect for apoplexy due to energy-deficiency and blood-stasis, the efficacy in the treated group was equal to that in the control group, and favourable satety for usage.