Objective：The aim of this study was to examine the efficacy and safety of hochuekkito to address reduced activities of daily living (ADL), nutritional status, and immunity in patients with severe conditions, represented by a functional independence measure (FIM) total score of ≤ 40.

Methods：Thirty-one patients who were undergoing rehabilitation for hemiplegia after cerebrovascular disease were randomized into 2 groups：those treated with hochuekkito (TJ-41 group) and those treated without hochuekkito (control group). Their conditions were observed for 24 weeks, focusing on items such as ADL and incidence of inflammatory complications.

Results：The FIM total score markedly improved after treatment in both groups, but the changes in the score between admission and discharge were similar between the two groups. The incidence of inflammatory complications was significantly lower in the TJ-41 group (P = 0.049). Among the patients with a motor FIM score of ≤ 20, those in the TJ-41 group showed a tendency of increase in total lymphocyte count after treatment. No adverse drug reactions were observed during the study period.

Conclusion：These results suggest that hochuekkito is effective in reducing the incidence of inflammatory complications in patients undergoing rehabilitation for cerebrovascular or other diseases.