Hepatoprotective Efficacy of Gene(R) L-Ergothioneine Capsules: A Self-Controlled Clinical Trial

ContextErogothioniene (EGT), a potent natural antioxidant, exerts hepatoprotection. However, human clinical evidence remains absent. Objectiveto observe the clinical efficacy and safety studies of GeneIII(R) L-Ergothioneine Capsules in the Hepatoprotective Efficacy. Materials and methodsThirty subjects with some abnormal liver function indicators were selected to take 2 capsules of 30mg GeneIII(R) L-Ergothioneine Capsules per day, for 30 consecutive days. The changes in serum liver function biomarkers, clinical efficacy self-rating scale, and Pittsburgh sleep quality index scale (PSQI) from baseline in different visit cycles were compared by self-control. All adverse events that occured after receiving the trial medication were also tracked and the incidence of adverse events during the trial period was calculated. ResultsAll subjects completed treatment and follow-up. After taking GeneIII(R) L-Ergothioneine Capsules, the subjects aspartate aminotransferase (AST) levels were significantly reduced compared to baseline (p=0.0082). Additionally, alanine aminotransferase (ALT) levels were also significantly reduced (p=0.0025), gamma-glutamyl transferase (GGT) levels were significantly reduced compared to baseline (p=0.0270). Physical function scores on the Clinical Efficacy Self-Assessment Scale improved significantly compared to baseline. Physical function scores decreased significantly by 39.04% compared to baseline (p<0.0001). Additionally, the level of daytime functional impairment on the Pittsburgh Sleep Quality Index was significantly reduced by 51.56% compared to baseline (p=0.0038). No adverse events occurred throughout the study. No side effects were observed clinically, confirming the reliable safety of GeneIII(R) L-Ergothioneine Capsules under the current study design. ConclusionGeneIII(R) L-Ergothioneine Capsules have a significant effect on improving liver function, physical function, and sleep quality in subjects, and the overall safety is good.