NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051210031

Registered date:02/06/2021

A study of the chamomile on sleep quality.

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPerson with any condition that causes a need for care in welfare facilities for older people, etc.
Date of first enrollment03/07/2021
Target sample size19
Countries of recruitment
Study typeInterventional
Intervention(s)Chamomile essential oil 1.2g / day or air is released intermittently once a day from bedtime to waking up for 7 consecutive days.

Outcome(s)

Primary OutcomeSleep quality: Changes in the score of the Pittsburgh Sleep Questionnaire revised from the original to the one-week version (change from the score on the first day of the release observation period as the baseline to the score on the first day of the post-release observation period ).
Secondary OutcomeEffectiveness evaluation outcomes: Changes in the time of wake-up in the sleep period that is counted by the heart rate and respiratory rate measured by the under-bed sensor. (change from the total time during the pre-release period as the baseline to the total time during the release period) Safety evaluation outcomes: Incidence of diseases during the observation period.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Resident of welfare facilities for older people, etc. 2. Person aged 20 years old or older. 3. Person with Pittsburgh Sleep Questionnaire Quality Index of 2 or higher 4. Person with no willingness to change the drug being taken during the study period. 5. Person who voluntarily consented to the document regarding participation in this study.
Exclude criteria1. Person with drug hypersensitivities such as aromas of essential oils. 2. Pregnant and lactating woman, or woman of childbearing potential. 3. Person inappropriately participating in this study at the discretion of the person in charge of this study.

Related Information

Contact

Public contact
Name Masanobu Okayama
Address 2-1-5 Arata-cho, Hyogo-ku, Kobe, Hyogo Hyogo Japan 652-0032
Telephone +81-78-382-6732
E-mail okayamam@med.kobe-u.ac.jp
Affiliation Kobe University Graduate School of Medicine
Scientific contact
Name Masanobu Okayama
Address 1-14-1 Agatsuma-cho, Hirohata-ku, Himeji, Hyogo Hyogo Japan 671-1154
Telephone +81-79-238-5725
E-mail okayamam@med.kobe-u.ac.jp
Affiliation Cosmos Village Hirohata