[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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Wu
Yi-Ling
YL
Medicinal Academy of Integrated Traditional and Western Medicine of Hebei province, Shijiazhuang 050035, China.
Li
Tao
T
Li
Yan
Y
Li
Jia-Kang
JK
Hu
Guo-Heng
GH
Gu
Chun-Hua
CH
Gao
Xue-Dong
XD
D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000818:Animals; D002214:Capsules; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000302:isolation & purification / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008419:Materia Medica / Q000737:chemistry*; D008875:Middle Aged; D010946:Plants, Medicinal / Q000737:chemistry*; D011208:Powders; D020521:Stroke / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
D002214:Capsules; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal; D008419:Materia Medica; D011208:Powders; C513941:tongxinluo