Safety evaluation of continuous administration of a high dose of Valeriana fauriei root extract in mice and in humans through an open‐label study

• DOI: 10.1002/tkm2.1388
• Publication Date: 2023-10-03T00:43:37Z
• Authors: Misato Ota; Yuki Oiwa; Yasuhito Maki; Ichiro Utaka; Sachie Arima; Yoichi Matsuo; Toshiaki Makino; Shunsuke Nojiri
• Keywords: 0303 health sciences; 03 medical and health sciences; 3. Good health

Abstract Aim This study aimed to clarify the safety of Valeriana fauriei root (VF) ethanol extract through in vivo and clinical trials. Methods Mice were divided into VF control groups. They given (4 g VF/kg/day) or vehicle mixed powdered food for four weeks. Food consumption body weight changes evaluated, blood biochemistry organ weights assessed on last day. In addition, an open‐label was conducted healthy subjects who took capsules (10 VF/body/day) weeks asked report any their physical condition. Physical, hematologic, biochemical examination urinalysis performed before, two weeks, study. Results gain mice did not differ between groups, except experimental error, there no particular differences brain, lung, heart, liver, spleen, kidney. mice, administration resulted small but significant decreases albumin males females, total cholesterol high‐density lipoprotein females only. These levels unchanged, daytime sleepiness observed humans. Conclusion Since little change values at continuous high doses 10 g/day, it can be concluded that approximately one‐fifth this dose (2 VF/day) is less harmful. However, should considered.