ID-GMG001의 숙취 개선 유효성 연구: 무작위, 이중맹검, 위약 대조군, 교차 인체적용시험

Efficacy of ID-GMG001 for the Alleviation of Hangover: A Randomized, Double-blind, Placebo-controlled, Crossover Human Study

This randomized, double-blind, placebo-controlled, crossover human study aimed to investigate the efficacy of ID-GMG001 for the alleviation of hangover in men between the ages of 20 and 50 years. The selected subjects were randomized to an ID-GMG001 group and a placebo group. Two overnight assessments were conducted at Kyunghee University Hospital exactly one week apart and at the same time of day. The subjects ingested placebo or ID-GMG001 and then consumed alcohol 30 minutes later to induce hangover. The efficacy of ID-GMG001 for alleviating hangover was determined based on serum acetaldehyde levels over time. After the experiment, the results of 21 subjects who met the assessment criteria (per-protocol set) were analyzed. Comparisons of area under the curve (AUC; p=0.032), dose at 4 and 6 hours after alcohol consumption (p=0.001 and p=0.008, respectively), showed that serum acetaldehyde concentrations were significantly lower in the ID-GMG001 group than in the placebo group. A safety assessment revealed no serious IDGMG001- related adverse events, and no significant changes in vital signs and laboratory parameters occurred that could have affected patient safety. In conclusion, we determined that the use of ID-GMG001 before alcohol consumption effectively alleviates hangover in adults by reducing serum acetaldehyde concentrations.