Evaluation of capsules containing Valeriana fauriei root extract for sleep improvement: A randomized, double-blind, placebo-controlled, cross-over comparative trial

Aim This clinical trial aimed to clarify the sleep-ameliorating effects of capsules containing Valeriana fauriei root (VF) extract and their adverse effects.Methods The trial was a randomized, double-blind, placebo-controlled, cross-over comparative clinical trial involving participants with an Athens Insomnia Scale (AIS) of 6 or higher, selected by prescreening questionnaires. After randomization, the participants took VF (2 g as VF/day) or placebo capsules for two weeks and were asked to complete the Obstructive Sleep Apnea (OSA) sleep questionnaire daily to assess their sleep status and any changes in their physical condition. On the last day of each term, the participants reported their sleep improvement experience.Results No significant differences were found between the VF and placebo groups on the OSA sleep questionnaire. Significantly, more participants in the VF-treated group experienced improvements in sleep onset and quality than those in the placebo group. The sleep onset improved particularly in those with early awakening, whereas the sleep quality particularly improved in those with midnight awakening. Although a few participants experienced physical, gastrointestinal and psychological changes when taking VF capsules, there was no significant difference from the placebo group, and no serious adverse events occurred.Conclusion We clinically determined that VF, a folk medicine, improves sleep onset and sleep quality in people with suspected insomnia without serious adverse events at the dosage of 2 g VF/day.