薬理と治療

Abstract

Objective　To examine the effects of matured red ginseng extrac（t MRGE）–containing food on improvement body temperature in healthy Japanese adults with cold hypersensitivity in hands and feet. Methods　This randomized, placebo–controlled, double–blind, parallel–group comparison study included 56 participants, randomly assigned in a ratio of 1: 1 to MRGE（216 mg/day）or placebo groups via a computer–generated random number. The participants consumed two tablets of MRGE–containing food or a placebo daily with water at any time of the day for 12 weeks. Palm skin surface temperature and blood flow before and after cold–water load, and subjective symptoms related to cold hypersensitivity in the hands and feet were evaluated. Cold–water loading was immersing hands in approximately 15℃ water at for 1 min. The primary outcome included the area under the curve（AUC）of the palm skin surface temperature, immediately to 30 min after the cold–water load. Results　The efficacy dataset was the per protocol set, with 26 participants in each of the MRGE and placebo groups. The MRGE 216 mg/day group demonstrated a significantly higher AUC immediately to 30 min after the cold–water load at 12 weeks after intake, and marginally improved coldness of fingertips than in the placebo group. No adverse events were observed. Conclusions　The 12–week intake of MRGE–containing food significantly increased palm skin surface temperature restoration in response to the cold–water load, significantly suppressed the decrease in palmar surface temperature, and markedly reduced the subjective fingertip coldness. These results demonstrate that thermoregulatory effect of MRGE maintains the warm surface temperature of the fingertips. Trial registration　UMIN000047708 Foundation　KIMʼs Korean Ginseng Co., Ltd.（Jpn Pharmacol Ther 2024；52：359‒91）