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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039412
Receipt No. R000044935
Scientific Title The effect of l-menthol on sensation of dyspnea and running performance
Date of disclosure of the study information 2020/02/07
Last modified on 2020/03/02

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Basic information
Public title The effect of l-menthol on sensation of dyspnea and running performance
Acronym Dyspnea of runners and l-menthol
Scientific Title The effect of l-menthol on sensation of dyspnea and running performance
Scientific Title:Acronym The effect of l-menthol on sensation of dyspnea and running performance
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to clarify if there is a difference in the threshold of dyspnea when a solution containing l-menthol was either swallowed or used for rinsing.
Basic objectives2 Others
Basic objectives -Others In order to clarify if there is a difference in the endurance time and distance covered when a solution containing l-menthol was either swallowed or used for rinsing.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Subjective dyspnea threshold
Key secondary outcomes Running distance and time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 swallowing/mouth rinsing l-menthol/water solution
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
20 years-old <=
Age-upper limit
55 years-old >
Gender Male
Key inclusion criteria 1. healthy adults
2. Running long distance daily (4-5 days/wK)
Key exclusion criteria 1. Musculoskeletal disorder/disease
2. Metabolic diseases.
3. Respiratory diseases.
4. Acute infectious diseases.
5. Visual/auditory failure
6. Food allergy
7. Exercise not permitted from a medical institutes
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Ryoichi
Middle name
Last name Nagatomi
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code 980-8575
Address Seiryo-machi, 2-1, Aoba-ku, Sendai, Japan
TEL 022-717-8586
Email nagatomi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Yoshiko
Middle name
Last name Tsutsumi
Organization Tohoku University
Division name Graduate Shool of Biomedical Engineering
Zip code 980-8575
Address Seiryo-machi, 2-1, Aoba-ku, Sendai, Japan
TEL 022-717-8586
Homepage URL
Email yoshiko@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Biomedical Engineering
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Biomedical Engineering
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Graduate School of Medicine
Address Seiryo-machi, 2-1, Aoba-ku, Sendai, Japan
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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 東北大学大学院医工学研究科

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 07 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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 06 Day
Date of IRB
2020 Year 02 Month 06 Day
Anticipated trial start date
2020 Year 02 Month 07 Day
Last follow-up date
2021 Year 01 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
2020 Year 02 Month 06 Day
Last modified on
2020 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044935

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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