UMIN-CTR Clinical Trial

Basic information
Public title	Alleviation degree of motion sickness symptoms by chewing peppermint gum
Acronym	Alleviation degree of motion sickness symptoms by chewing peppermint gum
Scientific Title	Alleviation degree of motion sickness symptoms by chewing peppermint gum -confirming the effectivity in bus-
Scientific Title:Acronym	Alleviation degree of motion sickness symptoms by chewing peppermint gum
Region	Japan

Condition
Condition	motion sickness
Classification by specialty	Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Aim of this study is to confirm the alleviation degree of chewing peppermint scented gum for motion sickness symptoms that occur when using a smartphone in bus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Numerical subjective evaluation value of discomfort
Key secondary outcomes	Results of questioner about motion sickness symptoms

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Chewing peppermint gum (two pieces)
Interventions/Control_2	No treatment
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	A healthy adult He/she has experience that occur motion sickness Consent to participate this experiment in writing
Key exclusion criteria	Pregnant and breast-feeder Who has food allergies for peppermint gum Too sensitive to motion sickness Do not feel any discomfort from motion sickness symptoms Who hates mint scented foods
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name OGAWA
Organization	Mie University
Division name	Faculty of engineering
Zip code	5148507
Address	1577 Kurimamachiya-cho Tsu city, Mie
TEL	+81592319459
Email	ogawa@ai.info.mie-u.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name OGAWA
Organization	Mie University
Division name	Faculty of engineering
Zip code	5148507
Address	1577 Kurimamachiya-cho Tsu city, Mie
TEL	+81592319459
Homepage URL
Email	ogawa@ai.info.mie-u.ac.jp

Sponsor
Institute	Mie University
Institute
Department

Funding Source
Organization	LOTTE 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	Faculty of engineering, Mie University
Address	1577 Kurimamachiya-cho Tsu city, Mie
Tel	0592319466
Email	eng-somu@eng.mie-u.ac.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	2022 Year 10 Month 19 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	44
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	2022 Year 03 Month 01 Day
Date of IRB	2022 Year 05 Month 11 Day
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2022 Year 07 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	2022 Year 10 Month 19 Day
Last modified on	2022 Year 10 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056101