UMIN-CTR Clinical Trial

Basic information
Public title	Difference of the effects to suppressing motion sickness between scented gum and tablets.
Acronym	Motion sickness suppressing effects of gum and tablets.
Scientific Title	Effects of food form on suppressing effect of peppermint scent for visually induced motion sickness.
Scientific Title:Acronym	VIMS suppressing effect of the scent at each food form.
Region	Japan

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

Objectives
Narrative objectives1	Confirming the efficacy of peppermint fragrance for suppressing VIMS and investigating the effect of masticatory movement on suppressing effect for VIMS of peppermint fragrance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Degree of symptom suppression
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	control
Interventions/Control_2	Food form conditions (gum)
Interventions/Control_3	Food form conditions (tablets)
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	1. Adult person 2. Those who can stay away from drinking from the day before the test to the end of the test 3. Get enough sleep at the day before the test and who feel good at the day of the test
Key exclusion criteria	Pregnant / lactating person Those with food allergies Those who have had serious symptoms of (visually induced) motion sickness Those who do not feel any of (visually induced) motion sickness
Target sample size	30

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 Prefecture, Japan
TEL	059-231-9459
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 Prefecture, Japan
TEL	059-231-9459
Homepage URL
Email	ogawa@ai.info.mie-u.ac.jp

Sponsor
Institute	Faculty of Engineering, 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	Mie University
Address	1577 Kurimamachiya-cho, Tsu City, Mie Prefecture, Japan
Tel	059-231-9466
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	2021 Year 04 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 07 Month 17 Day
Date of IRB	2020 Year 07 Month 21 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2021 Year 05 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	2021 Year 03 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=R000049882