UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031639 |
|---|---|
| Receipt number | R000036127 |
| Scientific Title | A study of physiological and psychological change by touching non-woven |
| Date of disclosure of the study information | 2018/03/08 |
| Last modified on | 2018/05/15 16:52:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of physiological and psychological change by touching non-woven
Acronym
Physiological and psychological change by touching non-woven
Scientific Title
A study of physiological and psychological change by touching non-woven
Scientific Title:Acronym
Physiological and psychological change by touching non-woven
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the physiological and psychological change by touching non-woven
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement and assessment of salivary hormones and psychological states before and after touching three kinds of non-woven
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
4
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Touching non-woven A->Touching non-woven C->Touching non-woven B->No touching
Interventions/Control_2
Touching non-woven B->No touching->Touching non-woven C->Touching non-woven A
Interventions/Control_3
Touching non-woven C->Touching non-woven A->No touching->Touching non-woven B
Interventions/Control_4
No touching->Touching non-woven B->Touching non-woven A->Touching non-woven C
Interventions/Control_5
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
-Subjects with using and experience of diapers
-Subjects without breastfeeding
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 taking prescription medicine
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Saito |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7683
saito.nao@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Sakamoto |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7682
Homepage URL
sakamoto.takashi@kao.com
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 03 | Month | 08 | 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 | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 08 | Day |
Last modified on
| 2018 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036127
