UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032742 |
|---|---|
| Receipt number | R000037343 |
| Scientific Title | A verification study of effectiveness to sleep and of influence on cognitive function of the black tea fragrance |
| Date of disclosure of the study information | 2018/05/30 |
| Last modified on | 2020/10/09 11:23:47 |
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Basic information
Public title
A verification study of effectiveness to sleep and of influence on cognitive function of the black tea fragrance
Acronym
A verification study of effectiveness to sleep and of influence on cognitive function of the black tea fragrance
Scientific Title
A verification study of effectiveness to sleep and of influence on cognitive function of the black tea fragrance
Scientific Title:Acronym
A verification study of effectiveness to sleep and of influence on cognitive function of the black tea fragrance
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effectiveness to improvement of sleep and the influence on cognitive function by smelling the black tea fragrance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Evaluation of sleep : QOL questionnaire
2.Evaluation of cognitive function : Brain stress test, Walking measurement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
During 4 weeks of first term, smell the fragrance of black tea for 3 hours a day at bedtime. Then visit the clinic, answer the QOL questionnaires, take the brain stress test and attend the walking measurement. During 4 weeks of second term, smell the fragrance of control for 3 hours a day at bedtime. Then visit the clinic, answer the QOL questionnaires, take the brain stress test and attend the walking measurement.
Interventions/Control_2
During 4 weeks of first term, smell the fragrance of control for 3 hours a day at bedtime. Then visit the clinic, answer the QOL questionnaires, take the brain stress test and attend the walking measurement. During 4 weeks of second term, smell the fragrance of the black tee for 3 hours a day at bedtime. Then visit the clinic, answer the QOL questionnaires, take the brain stress test and attend the walking measurement.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Male and females aged over 40 years old who recognize by themselves that they can't sleep well physiologically. (For examples, subjects who can't fall in sleep within 30 min, subjects who have middle awakening and/or subjects who are short of sleeping time)
(2) Subjects who don't dislike black tea.
(3) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
(1)Subjects who have been determined ineligible by the investigator of this clinical test.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yada |
Organization
University of Tsukuba
School of Integrative
Division name
Global Majors
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL
029-853-7344
yada.yukihiri.gb@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
University of Tsukuba
School of Integrative
Institute
Department
Personal name
Funding Source
Organization
Mitsui Norin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 28 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037343
