UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045619 |
|---|---|
| Receipt number | R000052083 |
| Scientific Title | A verification test of the effects on labor productivity of daytime rest habits using hot fomentation on eyes |
| Date of disclosure of the study information | 2021/10/05 |
| Last modified on | 2021/10/27 15:50:51 |
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Basic information
Public title
Efficacy test of daytime rest habits
Acronym
Efficacy test of daytime rest habits
Scientific Title
A verification test of the effects on labor productivity of daytime rest habits using hot fomentation on eyes
Scientific Title:Acronym
Efficacy test of daytime rest habits
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the ophthalmologic efficacy and effects of labor productivity of hot fomentation on eyes for healthy subjects
Basic objectives2
Others
Basic objectives -Others
Changes of QOL and working time by hot fomentation on eyes for healthy subjects
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Evaluation of the changes of ophthalmologic complaint, labor productivity, QOL, and working time after repeated treatment for 1week or 1week and 1month with hot fomentation on eyes.
Key secondary outcomes
-Analysis of the degree of eye complaint or improvement, personality, community site participation status, and the habitation of daytime rest
-Changes in stress level and presentism in 2021 and 2022
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the hot fomentation on eyes for 10 minutes once a day in the daytime. During the first week, the interventions are conducted for five consecutive days on weekdays. For the following month, the interventions are conducted at the time of preference, up to once a day.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females
Key exclusion criteria
-Subjects with diseases, inflammation, wounds, swelling, eczema, etc. around eyes
-Subjects who are conscious of being sensitive to warmth
-Subjects who are aware of the decrease in warm sensation
-Subjects who are not good at menthol stimulation
-Subjects have difficulty to treat hot fomentation on eyes in the daytime
-Pregnancies and lactations
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kyouko |
| Middle name | |
| Last name | Tagami |
Organization
Kao Corporation
Division name
Personal Health Care Products Research Laboratory
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7271
tagami.kyouko@kao.com
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Kitano |
Organization
Kao Corporation
Division name
Personal Health Care Products Research Laboratory
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7271
Homepage URL
kitano.junko@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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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(東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 30 | Day |
Last modified on
| 2021 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052083
