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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036105
Receipt No. R000041130
Scientific Title A study of physiological and psychological changes by touching fabric in the palm
Date of disclosure of the study information 2019/03/07
Last modified on 2019/07/17

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Basic information
Public title A study of physiological and psychological changes by touching fabric in the palm
Acronym Physiological change by touching fabric
Scientific Title A study of physiological and psychological changes by touching fabric in the palm
Scientific Title:Acronym Physiological change by touching fabric
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the physiological change by touching fabrics
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement physiological changes before and after touching fabrics
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Touching fabric A->Touching fabric E->Touching fabric B->Touching fabric D ->Touching fabric C
Interventions/Control_2 Touching fabric C->Touching fabric B->Touching fabric D->Touching fabric A ->Touching fabric E
Interventions/Control_3 Touching fabric E->Touching fabric D->Touching fabric A->Touching fabric C->Touching fabric B
Interventions/Control_4 Touching fabric D->Touching fabric C->Touching fabric E->Touching fabric B ->Touching fabric A
Interventions/Control_5 Touching fabric B->Touching fabric A->Touching fabric C->Touching fabric E -> Touching fabric D
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
59 years-old >=
Gender Female
Key inclusion criteria Healthy females
Key exclusion criteria -Subjects with systemic illness
-Subjects with a skin disease, and are consulting with the dermatologist
-Subjects with a severe rough hand
-Subjects with a disease in the oral cavity, and are consulting with the medical institution
-The pregnant and subjects who hope to get pregnant during the exam period
-Subjects who are breastfeeding
-Subjects who are taking prescription medicine
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Saito
Organization Kao Corporation
Division name Sensory Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7683
Email saito.nao@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Sakamoto
Organization Kao Corporation
Division name Sensory Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7682
Homepage URL
Email sakamoto.takashi@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
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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 07 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
2019 Year 02 Month 15 Day
Date of IRB
2019 Year 02 Month 15 Day
Anticipated trial start date
2019 Year 03 Month 07 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 07 Month 17 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 06 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041130

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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