UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032054 |
|---|---|
| Receipt number | R000036567 |
| Scientific Title | Continuous effect verification test of using development shorts at home |
| Date of disclosure of the study information | 2018/04/02 |
| Last modified on | 2020/04/06 18:15:25 |
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Basic information
Public title
Continuous effect verification test of using development shorts at home
Acronym
Effect verification test of development shorts
Scientific Title
Continuous effect verification test of using development shorts at home
Scientific Title:Acronym
Effect verification test of development shorts
Region
| Japan |
Condition
Condition
Healthy adult women
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
verification of the effect of development shorts in daily life
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluation of development shorts
Key secondary outcomes
Daily activity, Mood scale, Sleep evaluation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Wear development shorts->Wear regular shorts
Interventions/Control_2
Wear regular shortsshorts->Wear development shorts
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
| 55 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Female
Key inclusion criteria
-Healthy Women
-Those who are regular life
-The person who can attach an activity meter to the waist
Key exclusion criteria
-Those who with a pain (such as low back pain knee pain, surgery in the past)
-Those Who pacemakers and metals (stent or clip) is in the body
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoki Sudo |
Organization
Kao Corporation
Division name
R&D -Development Research-Personal Health Care Research Integrative Physiology Project.
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-7486
sudou.motoki@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Suzuki |
Organization
Kao Corporation
Division name
R&D -Development Research-Personal Health Care Research Integrative Physiology Project
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-9848
Homepage URL
suzuki.megumi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Women's University
Michiko Ohtsuka Lab.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 02 | 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 | 03 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 02 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036567
| 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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