UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037343