A Randomized, Double-blind, Placebo-controlled Study to the efficacy and Safety of NMED-01 and NMED-02 in Mild Alcoholic Liver Subjects

Objectives : The purpose of this study was to determine whether NMED-01 or NMED-02 improves laboratory test results in participants with liver function disorder. Methods : This is a randomized, placebo-controlled trial in which participants, treating physicians and data management staff were blinded to treatment group. The study was conducted at Semyung university oriental medicine hospital in Jecheon where participants with high level of serum ${\gamma}$-GTP (60-350 U/L) were enrolled. The intervention consisted of three times daily ingestion of either two capsules of placebo, NMED-01 (NeuMed. co. ltd., Seoul), or NMED-02 (NeuMed. co. ltd., Seoul) for twelve weeks. To evaluate the efficacy and safety of NMED-01 and NMED-02, we primarily evaluated the degree of decrement of serum ${\gamma}$-GPT level among three groups. Secondarily the decrement of serum ALT, AST, and triglyceride level in each group were also evaluated. Adverse effects were monitored during the twelve weeks treatment. Results : The change of ${\gamma}$-GTP level of NMED-01 group was lower than that of placebo group at the end of 12-week administration ($28.1{\pm}38.7U/L$ vs. $9.3{\pm}27.0U/L$, p=0.046). Other variables including AST, ALT, and triglyceride level were not significantly reduced. The decrement of ${\gamma}$-GPT, AST, ALT, and triglyceride level of NMED-02 group was not significant. There were no significant adverse effects or toxicities during treatment period. Conclusions : Participants receiving NMED-01 had improvement in laboratory test results. Despite a modest sample size, our results suggest that NMED-01 are safe and may be potentially effective in improving liver function. However, NMED-02 have lack of a detectable effect in this study.

NMED-01과 NMED-02의 간기능 개선에 대한 인체 효능 평가