UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049258 |
|---|---|
| Receipt number | R000056101 |
| Scientific Title | Alleviation degree of motion sickness symptoms by chewing peppermint gum -confirming the effectivity in bus- |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2022/10/19 07:17:17 |
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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
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
ogawa@ai.info.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056101
