UMIN-CTR Clinical Trial

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
Email	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
Email	suzuki.megumi@kao.co.jp

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	Infoward inc.,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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025111