UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021771 |
|---|---|
| Receipt number | R000025111 |
| Scientific Title | Effect verification test of body development shorts |
| Date of disclosure of the study information | 2016/04/06 |
| Last modified on | 2020/10/07 17:50:52 |
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Basic information
Public title
Effect verification test of body development shorts
Acronym
Effect verification test of body development shorts
Scientific Title
Effect verification test of body development shorts
Scientific Title:Acronym
Effect verification test of body 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
effective verification of development shorts by measuring 3D body, Motion analysis , Sitting pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At the time of development of shorts worn,Subjectivity,3D Body,Motion analysis,Sitting pressure
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Effectively verified in two kinds of intervention of shorts A and B.
Interventions/Control_2
Effectively verified in two kinds of intervention of shorts A and C.
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
| 65 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Female
Key inclusion criteria
-Healthy Woman
-Those who are regular life
-under BMI30
-Those who can be attached to the waist of the activity meter in a continuous
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
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Niki Yoshifumi |
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
niki.yoshifumi@kao.co.jp
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.co.jp
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
Infoward inc.,Japan Women's University
Michiko Ohtsuka Lab.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
KU-2016-04-001
Org. issuing International ID_1
Infoward inc.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
花王株式会社東京研究所（東京都）、日本女子大学大塚美智子研究室（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 06 | 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
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 04 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 04 | Day |
Last modified on
| 2020 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025111
