UMIN-CTR Clinical Trial

Basic information
Public title	A Study on change of the olfactory sensitivity
Acronym	A Study on change of the olfactory sensitivity
Scientific Title	A Study on change of the olfactory sensitivity
Scientific Title:Acronym	A Study on change of the olfactory sensitivity
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Oto-rhino-laryngology Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the changes of olfactory sensitivity
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of olfactory sensitivity
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Clean the tongue once a day for 2 weeks using a tongue brush
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	30 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adults
Key exclusion criteria	-Subjects who hospitalized or taking medication for chronic diseases (diabetes, heart / kidney / liver disease, congenital heart disease) -Subjects with disease in nose -Subjects who dislike perfume, or other odor substances -Subjects who are hypersensitive to chemicals -Subjects who are undergoing a hormone replace therapy -The pregnant and potentially pregnant, subjects in nursing -Subjects with an infectious disease -Subjects who take an antibiotics from 3 weeks before the screening test -Subjects with obvious intraoral injury -Subjects who are attending a dental clinic and receiving oral treatment -Subjects who are cleaning their tongue everyday -Subjects who cannot suspend tongue cleaning from the acquisition date of informed consent -Subjects with smoking habit -Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Sakamoto
Organization	Kao Corporation
Division name	Sensory Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7682
Email	sakamoto.takashi@kao.com

Public contact
Name of contact person	1st name Chisaki Middle name Last name Uehara
Organization	Kao Corporation
Division name	Sensory Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7682
Homepage URL
Email	uehara.chisaki@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
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	Human Research Ethics Committee, Kao Corporation
Address	2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel	+81-3-5630-7263
Email	morisaki.naoko@kao.com

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	花王株式会社（栃木県）

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 15 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	150
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 04 Month 15 Day
Date of IRB	2020 Year 04 Month 15 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 12 Month 09 Day

Other
Other related information

Management information
Registered date	2020 Year 06 Month 15 Day
Last modified on	2020 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046559