UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation test of influence to autonomic nervous by inhalation of the fragrances
Acronym	An evaluation test of influence to autonomic nervous by inhalation of the fragrances
Scientific Title	An evaluation test of influence to autonomic nervous by inhalation of the fragrances
Scientific Title:Acronym	An evaluation test of influence to autonomic nervous by inhalation of the fragrances
Region	Japan

Condition
Condition	No applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To consider of influences of four kinds of fragrances which are included in black tea to autonomic nervous system and the optimum concentration of each fragrances.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	* Evaluation of autonomic nervous system by pupillary measurement and skin temperature measurement * VAS questionnaire of feeling about fragrances and mood
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Test day 1 : measurement - suction of control fragrance - measurement - suction of fragrance A - measurement Test day 2 : measurement - suction of control fragrance - measurement - suction of fragrance B - measurement Test day 3 : measurement - suction of control fragrance - measurement - suction of fragrance C - measurement Test day 4 : measurement - suction of control fragrance - measurement - suction of fragrance D - measurement
Interventions/Control_2
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	20 years-old <=
Age-upper limit	49 years-old >=
Gender	Female
Key inclusion criteria	(1) Females aged 20 to 49 years old. (2) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.
Key exclusion criteria	(1) Subjects who dislike the scent of black tea. (2) Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer) (3) Subjects who have stuffy nose from allergic rhinitis or who can't distinguish scent. (4) Pregnant or expected pregnant, or lactating women. (5) Subjects who have undergone surgery on investigation objective portion, such as eye, forehead and/or fingertip, within the past 6 months. (6) Others who have been determined ineligible by investigator.
Target sample size	20

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 426-0133, Japan
TEL	054-648-2600
Email	masayuks@mitsui-norin.co.jp

Public contact
Name of contact person	1st name Koharu Middle name Last name Okumura
Organization	Mitsui Norin Co., Ltd.
Division name	Fundamental development team, R&D group
Zip code	426-0133
Address	223-1, Miyabara, Fujieda-city, Shizuoka 426-0133, Japan
TEL	054-648-2600
Homepage URL
Email	k.okumura@mitsui-norin.co.jp

Sponsor
Institute	Mitsui Norin Co., Ltd.
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 Sanwauchikannda 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 09 Month 01 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	2019 Year 08 Month 19 Day
Date of IRB	2019 Year 08 Month 16 Day
Anticipated trial start date	2019 Year 09 Month 09 Day
Last follow-up date	2019 Year 12 Month 31 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 08 Month 30 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=R000043167