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)

서지정보

· 발행기관 : 대한약학회
· 수록지 정보 : 약 학 회 지 / 64권 / 4호 / 327 ~ 333페이지
· 저자명 : 김민철, 박하영, 박종미, 임현정, 박주현, 전걸순, 이동한

초록

This randomized, double-blind, placebo-controlled, crossover human study aimed to investigate the efficacy ofID-GMG001 for the alleviation of hangover in men between the ages of 20 and 50 years. The selected subjects wererandomized to an ID-GMG001 group and a placebo group. Two overnight assessments were conducted at KyungheeUniversity Hospital exactly one week apart and at the same time of day. The subjects ingested placebo or ID-GMG001and then consumed alcohol 30 minutes later to induce hangover. The efficacy of ID-GMG001 for alleviating hangover wasdetermined based on serum acetaldehyde levels over time. After the experiment, the results of 21 subjects who met theassessment criteria (per-protocol set) were analyzed. Comparisons of area under the curve (AUC; p=0.032), dose at 4 and6 hours after alcohol consumption (p=0.001 and p=0.008, respectively), showed that serum acetaldehyde concentrationswere 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 couldhave affected patient safety. In conclusion, we determined that the use of ID-GMG001 before alcohol consumptioneffectively alleviates hangover in adults by reducing serum acetaldehyde concentrations.

영어초록

This randomized, double-blind, placebo-controlled, crossover human study aimed to investigate the efficacy ofID-GMG001 for the alleviation of hangover in men between the ages of 20 and 50 years. The selected subjects wererandomized to an ID-GMG001 group and a placebo group. Two overnight assessments were conducted at KyungheeUniversity Hospital exactly one week apart and at the same time of day. The subjects ingested placebo or ID-GMG001and then consumed alcohol 30 minutes later to induce hangover. The efficacy of ID-GMG001 for alleviating hangover wasdetermined based on serum acetaldehyde levels over time. After the experiment, the results of 21 subjects who met theassessment criteria (per-protocol set) were analyzed. Comparisons of area under the curve (AUC; p=0.032), dose at 4 and6 hours after alcohol consumption (p=0.001 and p=0.008, respectively), showed that serum acetaldehyde concentrationswere 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 couldhave affected patient safety. In conclusion, we determined that the use of ID-GMG001 before alcohol consumptioneffectively alleviates hangover in adults by reducing serum acetaldehyde concentrations.

참고자료

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