[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.
Medicinal Academy of Integrated Traditional and Western Medicine of Hebei province, Shijiazhuang 050035, China.
Yi-Ling
YL
Wu
Tao
T
Li
Yan
Y
Li
Jia-Kang
JK
Li
Guo-Heng
GH
Hu
Chun-Hua
CH
Gu
Xue-Dong
XD
Gao
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