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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025111


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name