UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of concentration and relaxation using scents for professional soccer players.
Acronym	Evaluation of concentration and relaxation using scents for professional soccer players.
Scientific Title	Evaluation of concentration and relaxation using scents for professional soccer players.
Scientific Title:Acronym	Evaluation of concentration and relaxation using scents for professional soccer players.
Region	Japan

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

Objectives
Narrative objectives1	To verify the influence to concentration and relaxation when smelling aroma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Heart beat Body temperature Body motion Acceleration The result of concentration tests
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Do concentration test with green fragrance in the air wearing heart rate monitor.
Interventions/Control_2	Do concentration test without any fragrance in the air wearing heart rate monitor.
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	19 years-old <=
Age-upper limit	50 years-old >
Gender	Male
Key inclusion criteria	1)Professional soccer player of Iwaki FC. 2)Who shows understanding of this study procedures and agreement with participating the study by written informed consent prior to the study. 3)Who can fill in the questionnaires. 4)Healthy individuals
Key exclusion criteria	1)Who has/may have allergy. 2)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 AKARI Middle name Last name HOSHI
Organization	ROHTO Pharmaceutical Co., Ltd.
Division name	Business Strategy Office
Zip code	1050014
Address	ROHTO Tokyo Bldg F5. 1-7-5, Shiba, Minato-ku, Tokyo
TEL	080-9931-8609
Email	hoshi@rohto.co.jp

Public contact
Name of contact person	1st name AMI Middle name Last name MIURA
Organization	KANSEI Projects Committee
Division name	Project Coordinator
Zip code	1540011
Address	#6 THE FORUM setagaya 5-15-15 Kamiuma Setagaya, Tokyo
TEL	080-5693-4413
Homepage URL
Email	miura@kanseiproject.com

Sponsor
Institute	ROHTO Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	ROHTO Pharmaceutical 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	Clinical Research Ethics Review Committee
Address	1-8-1 Tatsumi nishi Ikuno Osaka, Osaka
Tel	0774-71-8820
Email	takeuchiy@rohto.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 10 Month 07 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	No longer recruiting
Date of protocol fixation	2020 Year 09 Month 23 Day
Date of IRB	2020 Year 09 Month 23 Day
Anticipated trial start date	2020 Year 10 Month 08 Day
Last follow-up date	2020 Year 12 Month 30 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 10 Month 07 Day
Last modified on	2020 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047968