薬理と治療

Abstract

Objective　The study aimed to verify that continuous intake of a dietary supplement containing agrimols derived from Agrimonia pilosa Ledeb. would affect the quality of life(QOL). Methods　A randomized, double–blind, placebo–controlled, parallel–group trial was conducted on 82 healthy volunteers aged 40 to 60 years. Subjects intook the dietary supplement containing 0.2 mg of agrimols derived from Agrimonia pilosa Ledeb. or placebo for 12 consecutive weeks. The primary effects of the dietary supplement on QOL was evaluated by the Profile of Mood States 2nd edition(POMS2). The safety of an intake of the agrimols derived from Agrimonia pilosa Ledeb. was evaluated by the physical measurements, blood tests, urinalysis and adverse events. Results　Intake of the dietary supplement containing agrimols derived from Agrimonia pilosa Ledeb. significantly improved fatigue–inertia and vigor–activity of the POMS2 after 12 consecutive weeks. However, no significant improvements were observed in other endpoints. No adverse events related to intake of the agrimols derived from Agrimonia pilosa Ledeb. occurred. Conclusions　These results indicate that the dietary supplement containing agrimols derived from Agrimonia pilosa Ledeb. improved fatigue–inertia and vigor–activity which are both part of QOL, after 12 consecutive weeks of intake. Altogether, these findings imply that the intake of the supplement showed slight positive effects on QOL. No safety problem was observed in an intake of the agrimols derived from Agrimonia pilosa Ledeb. under the present evaluation condition. (UMIN ID: UMIN000051493)(Jpn Pharmacol Ther 2024;52:775‒89)