UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation study of change in auto-nervous system by suctioning of the aroma component.
Acronym	An evaluation study of change in auto-nervous system by suctioning of the aroma component.
Scientific Title	An evaluation study of change in auto-nervous system by suctioning of the aroma component.
Scientific Title:Acronym	An evaluation study of change in auto-nervous system by suctioning of the aroma component.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the influence to auto-nervous system and to physiological actions by suctioning of the aroma component.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Evaluation of autonomic nervous system (pupil versus light reflection, skin temperature) * Evaluation of central nervous system (NIRS)
Key secondary outcomes	* Salivary substances (Chromogranin A, Oxytocin) *Multiple mood scale (short version, 40 question) *VAS questionnaire about fragrance and mood * Incidence of adverse events and side effects

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	Questionnaire - saliva sampling - presenting control sample - saliva sampling - presenting control sample - measuring autonomic nervous system - presenting test sampling - measuring autonomic nervous system - presenting test sampling - saliva sampling - presenting control sample - measuring skin surface temperature - presenting test sampling - measuring skin surface temperature - presenting control sample - measuring central nervous system - presenting test sampling - measuring central nervous system - saliva sampling - questionnaire
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	40 years-old >
Gender	Female
Key inclusion criteria	1) Females aged 20 to 39 years old when consent obtain. 2) 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 dislike the fragrance of black tea 2) Females who have smoking habit. 3) Females who are cold-sensitive constitution. 4) Females who are receiving medication due to treatment of some disease within current one month before the test. 5) Females who are receiving treatment for pollen allergy within current one month before the test. 6) Females with stuffy nose such as allergic rhinitis or females who can't identify the fragrance. 7) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood. 8) 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. 9) Females who are pregnant or are lactating. 10) Females who have symptom of dermatologic disease such as atopic dermatitis. 11) Females who have undergone surgery on investigation objective portion within the past 6 months. 12) Females who are being treated by dentist, or females who plan to go dentist for receiving treatment. 13) Females who are participating the other clinical tests of medicines or foods. Females who participated other clinical tests of medicines or foods within a month prior to the current study. 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	054-648-2600
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	2021 Year 02 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	2020 Year 01 Month 20 Day
Date of IRB	2020 Year 01 Month 17 Day
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2020 Year 02 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2021 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044866