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

ABSTRACT 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 γ-GTP (60-350 U/L) were enrolled. The intervention consisted of three times daily ingestion of ei ther two capsules of placebo, NMED-01 (NeuMed. co. ltd., Seoul), or NMED-02 (NeuMed. co. ltd., Seoul) for twel ve weeks. To evaluate the efficacy and safety of NMED-01 and NMED-02, we primarily evaluated the degree of decre ment of serum γ-GPT level among three groups. Secondarily the decrement of serum ALT, AST, and trigly ceride level in each group were also evaluated. Adverse effects were monitored during the twelve weeks treatment.Results : The change of γ-GTP level of NMED-01 group was lower than that of placebo group at the end of 12-week administration (28.1±38.7 U/L vs. 9.3±27.0 U/L, p=0.046 ). Other variables including AST, ALT, and triglyceride level were not significantly reduced. The decremen t of γ-GPT, AST, ALT, and triglyceride level of NMED-02 group was not significant. There were no significant ad verse effects or toxicities during treatment period.Conclusions : Participants receiving NMED-01 had improvement in laboratory t est 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.Key words : Hovenia dulcis, Pueraria lobata, γ-GPT, hepatoprotective effect, alcohol, liver, liver function