Unique ID issued by UMIN | UMIN000036770 |
---|---|
Receipt number | R000041897 |
Scientific Title | A confirmation study of effectiveness to sleep by suction of the aroma component of black tea. |
Date of disclosure of the study information | 2020/05/17 |
Last modified on | 2020/10/09 11:49:41 |
A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
Japan |
Not applicable
Not applicable |
Others
NO
To confirm the effectiveness to improvement of sleep by suction the aroma component of black tea.
Efficacy
1. OSA sleep inventory
2. Pittsburgh Sleep Quality Index
1. SCL30
2. Activity level
3. The incidence of side effects and/or adverse events.
Interventional
Cross-over
Randomized
Individual
Open -but assessor(s) are blinded
Placebo
2
Prevention
Other |
During 7 days of first term, suction the aroma component of black tea for 3 hours a day at bedtime under natural respiration. A day rest. During 7 days of second term, suction control for 3 hours a day at bedtime under natural respiration.
During 7 days of first term, suction control for 3 hours a day at bedtime under natural respiration. A day rest. During 7 days of second term, suction the aroma component of black tea for 3 hours a day at bedtime under natural respiration.
30 | years-old | <= |
45 | years-old | >= |
Female
(1) Females aged 30 to 45 years old who can't sleep well physiologically. (
For examples, female who can't fall in sleep within 30 min, female who have middle awakening and/or female who are short of sleeping time)
(2) Females who work over 4 days, 3.5 hours a day.
(3) Females who can quit using of smartphone, cell phone and/or PC from one hour before bedtime.
(4) Females who don't dislike black tea.
(5) Females who can quit drinking alcohol and caffeine after 5 pm during the test.
(6) Females who have no plan of going to travel and/or staying at outside of the home during the test.
(7) Females who can smell the aroma of black tea by diffuser at their own home during the test.
(8) Females who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
(1) Females who have smoking habit.
(2) Females who are cold-sensitive constitution. (including females like that who feel cold on their hands and foots even in summer)
(3) Females with stuffy nose or subjects who can't identify the fragrance.
(4) Females who are currently receiving medication due to treatment of disease.
(5) Females who go to hospital and/or subject who receive medicine, for treatment of sleep disorder.
(6) Females who use supplements and/or health foods suspected to have influence to sleep.
(7) Females with high blood pressure symptoms such as systolic blood pressure of 160 mmHg and more or diastolic blood pressure of 100 mmHg and more.
(8) Females who notice their menopausal symptom.
(9) Females who are pregnant (including the possibility of pregnancy) or are lactating.
(10) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
(11) In the past month, subjects who have had custom of taking or applying medicine for the treatment of diseases.
(12) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells health / functional foods and cosmetics.
(13) Subjects who have environment for sleep with their children or family at bed time.
(14)Others who have been determined ineligible by principal investigator or sub-investigator.
24
1st name | Masayuki |
Middle name | |
Last name | Suzuki |
Mitsui Norin Co., Ltd.
R&D Group
426-0133
223-1 Miyabara, Fujieda-city, Shizuoka-prefecture, 426-0133,JAPAN
054-639-2600
masayuks@mitsui-norin.co.jp
1st name | Masanori |
Middle name | |
Last name | Numa |
CPCC Company Limited
Planning & Sales Department
101-0047
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5297-3112
cpcc-contact@cpcc.co.jp
CPCC Company Limited
Mitsui Norin Co., Ltd.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
03-5297-5548
IRB@cpcc.co.jp
NO
2020 | Year | 05 | Month | 17 | Day |
Unpublished
24
Completed
2019 | Year | 04 | Month | 19 | Day |
2019 | Year | 04 | Month | 19 | Day |
2019 | Year | 05 | Month | 17 | Day |
2019 | Year | 06 | Month | 01 | Day |
2019 | Year | 05 | Month | 16 | Day |
2020 | Year | 10 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041897