오적산 혼합단미엑스산제와 혼합단미연조엑스제의 안전성 평가를 위한 단일 기관, 무작위 배정, 교차 연구

Safety of Ojeok-san Extract Powder and Soft Extract in Healthy Male Volunteers, Single Center, Randomized Controlled, Cross-over Study

Objectives The purpose of this study is to evaluate the safety of Ojeok-san extract powder and soft extract in healthy male volunteers. Methods Randomized controlled, cross over study was carried out in healthy male volunteers. Total 27 of 31 subjects meeting the inclusion criteria were enrolled and three subjects for waiting were included. To each group 12 subjects were randomly allocated by random number table. Group A took the extract powder in the first period and then took the soft extract in the second period. Group B took the medicine in the opposite order. Trial was conducted through two times of hospitalizations and all subjects had a seven-days of wash out period. Vital sign and laboratory test were checked before and after the medication. The mean difference of safety evaluation variables were analyzed by paired t-test (p<0.001) or wilcoxon signed rank test (p<0.05). The mean difference between two groups were analyzed by independent t-test (p<0.05) or Mann whitney test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, There were no significant differences associated with the clinical trial drug between before and after the medication. And there was no adverse event associated with the clinical trial drug. Conclusions Both Ojeok-san extract powder and soft extract were found to be safe for healthy male volunteers.