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China Journal of Chinese Materia Medica ; (24): 1928-1931, 2007.
Article in Chinese | WPRIM | ID: wpr-307556

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the clinical efficacy and security of super crush-run tong xinluo capsule (SCTXLC) for apoplexy due to energy-deficiency and blood-stasis.</p><p><b>METHOD</b>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.</p><p><b>RESULT</b>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.</p><p><b>CONCLUSION</b>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.</p>


Subject(s)
Adult , Aged , Animals , Female , Humans , Male , Middle Aged , Activities of Daily Living , Capsules , Double-Blind Method , Drug Administration Schedule , Drug Combinations , Drugs, Chinese Herbal , Therapeutic Uses , Materia Medica , Chemistry , Plants, Medicinal , Chemistry , Powders , Stroke , Drug Therapy , Treatment Outcome
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