UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031813 |
|---|---|
| Receipt number | R000036318 |
| Scientific Title | Research on evaluation of developed new-functionality underclothes using new material |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/09/21 12:07:12 |
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Basic information
Public title
Research on evaluation of developed new-functionality underclothes using new material
Acronym
Research on evaluation of developed new-functionality underclothes using new material
Scientific Title
Research on evaluation of developed new-functionality underclothes using new material
Scientific Title:Acronym
Research on evaluation of developed new-functionality underclothes using new material
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate windbreak performance, hold warmth, and moisture vapor permeability of new-functionality underclothes compared with ready-made materials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inner temperature and humidity, surface temperature and heat flux, and thermogorapgh of new-functionality underclothes and intermediate clothes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wearing new-functionality underclothes.
Sitting at rest (3-10m/s of wind velosity) + walking (3m/s of fixed wind velosity, 40-120m/min of walking speed) at 10 degrees C for 30 minutes, respectively.
Interventions/Control_2
Wearing ready-made underclothes.
Sitting at rest (3-10m/s of wind velosity) + walking (3m/s of fixed wind velosity, 40-120m/min of walking speed) at 10 degrees C for 30 minutes, respectively.
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1)Age <= 20yaers old to > 40years old at the time if informed consent
2)Volunteers who are fully informed of and understand the objectives, procedures, and possible risks of the study and provide the written voluntary consent to participate in the study.
Key exclusion criteria
1)Diseases which need physical work restriction
2)Cardiovascular diseases, arrhhythmia
3)Hypertension (resting blood presure, SBP > or = 140 mmHg, DBP > or = 90mmHg)
4)Metabolic and endcrine disease
5)Smokers
6)Obesity (BMI <= 30kg/m2)
7)Ineligible by a medical interview
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Daiki |
| Middle name | |
| Last name | Imai |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
5588585
Address
3-3-138, Sugimoto, Sumiyoshi, Osaka
TEL
06-6605-2946
dimai@sports.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Imai |
| Middle name | |
| Last name | Daiki |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
5588585
Address
3-3-138, Sugimoto, Sumiyoshi, Osaka
TEL
06-6605-2946
Homepage URL
dimai@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
AS corporation
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
The Ethics Committee of Osaka City University Graduate School of Medicine
Address
1-2-7,Asahi-machi,Abeno-ku,Osaka
Tel
06-6645-3435
ethics@med.osaka-cu.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
| 2018 | 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
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2018 | Year | 03 | Month | 20 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036318
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
