薬理と治療

Abstract

Objective　The goal of this study was to assess the effects of food containing matured red ginseng extract（MRGE）on sleep quality in healthy Japanese adults with sleep quality problems. Methods　Fifty-six participants were randomly assigned to two groups via a computer program in a 1：1 ratio. Furthermore, they were asked to take two tablets of the test food（MRGE-containing food）or the placebo at any time for 12 weeks with water. The assessment items were the OSA Sleep Study MA（OSA-MA）, subjective symptoms using the Likert scale, and objective sleep evaluation. Results　The efficacy analysis data set was a per protocol set, and 27 subjects were included in the analysis for each group. The primary outcome, which was the sleepiness on rising of OSA-MA, was significantly improved in the MRGE group compared with the placebo group. Further, some of the sub-items of sleepiness on rising（concentration, and feeling of freedom）were improved. In the evaluation of subjective symptoms, it was confirmed that worries at the time of falling asleep were significantly reduced. Moreover, in the evaluation of sleep, there was a significantly deeper sleep in the MRGE group than the placebo group. There were no adverse events or side effects found to be causally related to the test food. Conclusions　The 12-week intake of a food containing MRGE was found to improve sleep quality in healthy Japanese adults with sleep quality problems. Trial registration　UMIN000042444 Foundation　KIMʼs Korean Ginseng Co., Ltd. （Jpn Pharmacol Ther 2022；50：801‒15）