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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032054
Receipt No. 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

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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
Email 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
Email suzuki.megumi@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036567

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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