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 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 γ-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 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 decrement of γ-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.

Safety evaluation of root extract of Pueraria lobata and Scutellaria baicalensis in rats

“…However, most evidence suggests that P. lobata and puerarin have hepatoprotective effects in animal models of hepatotoxicity [ 35 – 40 ]. Also, administration of P. lobata extract for 12 weeks did not affect ALT and AST levels in human subjects with elevated serum γ-glutamyl transferase levels due to alcohol consumption [ 41 ]. Baicalin, the major compound of S. baicalensis , has been reported to induce kidney injury and fibrosis in rats at high doses (≥ 400 mg/kg/day per os ); yet the highest administered baicalin dose in this study was approximately 200 mg/kg/day, which is lower than the reported toxic dose [ 24 ].…”