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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043682
Receipt No. R000049882
Scientific Title Effects of food form on suppressing effect of peppermint scent for visually induced motion sickness.
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/19

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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 Enrolling by invitation
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
2021 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049882

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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