UMIN-CTR Clinical Trial

Basic information
Public title	A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
Acronym	A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
Scientific Title	A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
Scientific Title:Acronym	A confirmation study of effectiveness to sleep by suction of the aroma component of black tea.
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 by suction the aroma component of black tea.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. OSA sleep inventory 2. Pittsburgh Sleep Quality Index
Key secondary outcomes	1. SCL30 2. Activity level 3. The incidence of side effects and/or adverse events.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	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.
Interventions/Control_2	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.
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	30 years-old <=
Age-upper limit	45 years-old >=
Gender	Female
Key inclusion criteria	(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.
Key exclusion criteria	(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.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Suzuki
Organization	Mitsui Norin Co., Ltd.
Division name	R&D Group
Zip code	426-0133
Address	223-1 Miyabara, Fujieda-city, Shizuoka-prefecture, 426-0133,JAPAN
TEL	054-639-2600
Email	masayuks@mitsui-norin.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikanda 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	CPCC Company Limited
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 Sanwauchikanda 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	2020 Year 05 Month 17 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	24
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	2019 Year 04 Month 19 Day
Date of IRB	2019 Year 04 Month 19 Day
Anticipated trial start date	2019 Year 05 Month 17 Day
Last follow-up date	2019 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 16 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=R000041897