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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032742
Receipt No. 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 2018/11/26

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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
Middle name
Last name Yukihiro Yada
Organization University of Tsukuba
School of Integrative
Division name Global Majors
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL 029-853-7344
Email yada.yukihiri.gb@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ichinohe
Organization CPCC Company Limited
Division name Planning & Sales Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute University of Tsukuba
School of Integrative
Institute
Department

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
Address
Tel
Email

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
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037343

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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