Objective:To evaluate the efficacy and safety of Zhen Xuan Tong Luo capsule in the treatment of stroke (cerebral infarction), and to investigate the mechanism of action, to provide a scientific basis for its clinical application.Methods:This is a randomized, double-blind, placebo, parallel-group clinical trials. Select60patients who met the inclusion criteria and randomly divided into3groups. Each group with20patients.The treatment group (the high-dose group) was given5Zhen Xuan Tong Luo capsules3times daily, the3+2group (the low-dose group) was given3Zhen Xuan Tong Luo capsules plus2analog capsules3times daily, then the control group was given5analog capsules3times daily. Every enrolled patient was given100mg Aspirin Enteric-coated Tablets daily as a basis drug for treatment of28days. Clinical curative effect and assaying items were observed after one course of treatment.Results:TCM efficacy comparison:The total effective rate in the treated group(70%)was more effective than that in the3+2group(50%) and the control group(20%). The difference was significant(P<0.05). Neurological deficit scores comparison:the scores in the three groups all decreased. And the scores in the treatment group were obviously better than the remaining two groups. The difference was markedly significant(P<0.05).ADL comparison:The scores before and after treatments were all increased in three groups, and there had significant difference between them(P<0.05).Conclusion:The Zhen Xuan Tong Luo capsule can significantly improve the total effective rate of TCM, reducing neurological deficit scores, improve the patient’s quality of life, and no significant side effects. |