The Effect Of Huotuo Zaizao Pills For Cerebral Infarction In Convalescent Stage: A Randomized, Double-blind, Placebo-cotrolled, Multicenter Clinical Trial

Objective:To evaluate the effect of Huatuo Zaizao Pills (HZP) for cerebral infarction in convalescent stage and discuss the HZP-treated appropriate TCM Syndrome.Methods:A randomized, double-blind, placebo-controlled, multicenter clinical study was conducted in our study, and 228 patients meeting the inclusion criterions, based on the conventional treatment for 6 months, were randomly divided into HZP group, or placebo control group. HZP group were given as 8 grams per time and twice a day; while placebo group were administrated as same as the HZP group. At the first 4-week,8-week,12-week,16-week,20-week, and 24 weeks after treatment, NIH Stroke Scale (NIHSS), Barthel Index (BI), modified Rankin Scale (mRS) for the evaluation of disability, and the TCM syndrome were evaluated respectively. Before the treatment, at 12-week after treatment and at the end of the treatment, the liver function (ALT, AST), renal function (BUN, Cr) and blood glucose were inspected, and the adverse reactions were monitored and recorded in time if occurred.Results:A total of 228 cases were statistically included in the full analysis set (FAS), and 194 cases were analyzed in per protocol set (PPS).The phlegm syndrome of stroke and symptoms such as dizziness were significantly improved and the NIHSS was obviously reduced in HZP group after treatment (P <0.05). However, there were not any significant differences of BI scale and Rankin Scale between the two groups (P>0.05). The safety analysis result showed that there was neither any difference in these two groups (P>0.05).Conclusion:HZP can promote the recovery of neurological function in patients with cerebral infarction, effectively improve the TCM phlegm syndrome and the dizzy symptom. And HZP has reliable safety.