薬理と治療

Abstract

Objectives　To investigate the sleep-improving effects of Hypnocallis® derived from Kwanso （Hemerocallis fulva var. sempervirens）, a randomized, placebo-controlled, parallel-group study was conducted in 63 individuals with sleep disorder who were otherwise healthy. Primary outcome of the study was the Pittsburgh Sleep Quality Index score and the OSA sleep inventory score. Methods　Among 198 otherwise healthy volunteers, 63 individuals with sleep disorder were selected according to their Pittsburgh Sleep Quality Index（PSQI）scores. Twenty-one participants each were randomized to either ingest food containing Hypnocallis® 2000 mg, Hypnocallis ® 1000 mg, or placebo over a period of 2 weeks. During week 2 of ingestion, the OSA sleep inventory score was measured. Results　All 63 participants completed the study. Analyses of OSA sleep questionnaire responses showed significant differences in sleepiness on rising（factor Ⅰ）, initiation and maintenance of sleep（factor Ⅱ）, and dreaming（factor Ⅲ）for Hypnocallis® 1000 mg versus placebo. Also, for Hypnocallis® 2000 mg versus placebo, it showed significant differences in sleepiness on rising（factor Ⅰ）, initiation and maintenance of sleep （factor Ⅱ）, and refreshing （factor Ⅲ）. The adverse event to assume intake of the study food origin during an intake period did not occur, and there was not the safe problem to intake of the Hypnocallis® extract. Conclusion　In Hypnocallis® which was standardized extract derived from Kwanso improved quality of the sleep of the healthy subject as compared with placebo food in both 1,000 mg of intake group and 2000 mg of intake group. In particular for the Hypnocallis® 2000 mg intake group was improved to sleepiness on rising, initiation and maintenance of sleep, and refreshing.（UMINID: UMIN000040717）