UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052424 |
|---|---|
| Receipt number | R000059833 |
| Scientific Title | Research on the effects of cosmetics on sleep improvement |
| Date of disclosure of the study information | 2023/10/09 |
| Last modified on | 2023/10/05 15:23:02 |
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Basic information
Public title
Research on the effects of cosmetics on sleep improvement
Acronym
Sleep test
Scientific Title
Research on the effects of cosmetics on sleep improvement
Scientific Title:Acronym
Sleep test
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The test product will be used with massage to explore the effects of relaxation on sleep improvement in adults between the ages of 20 and 69 for 6 consecutive days.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes on sleeping
Questionnaire
Key secondary outcomes
Questionnaire on skin quality improvement
Questionnaire on the use of test products
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Sleep and drinking/drinking restrictions In addition to the usual routine, except for the rerictions on sleeping and drinking, the test product is to be used 30 minutes before bedtime every day for 6 days. 30 minutes before bedtime every day for 6 days.
Interventions/Control_2
Restrictions regarding sleep and alcohol and beverages Except for matters related to
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
| 69 | years-old | > |
Gender
Female
Key inclusion criteria
1.Those who have been fully informed of the purpose and content of this study, have the capacity to consent, and fully understand and agree to participate in this study in writing.
2.Japanese women aged 20 to 69 at the time of consent.
3.Those who are aware of skin care or are practicing some form of skin care.
4.Those who suffer from stress-related sleep problems.
Key exclusion criteria
1.Patients with chronic illnesses who are receiving drug treatment or have a history of serious illnesses.
2.Those who have been diagnosed with insomnia, sleep apnea, or other sleep disorders, and who are taking medications such as sleep inducers or insomnia medications (including OTC medications as well as prescription medications) or who are being treated with CPAP, mouthpieces, etc. )
3.Those who have been diagnosed and treated for allergic diseases such as atopic dermatitis, asthma, allergic rhinitis, etc.
4.Persons who are allergic to the test product.
5.Those who regularly consume pharmaceuticals, health foods (food for specified health use, food with functional claims, and food with nutrient function claims), etc., that may affect sleep.
6.Those whose BMI exceeds 30.
7.Those who are mainly in charge of taking care of those who need nursing care or infants.
8.Those who work late at night, shift work, or heavy labor.
9.Those who cannot sleep alone on one bedding (futon or bed, etc.) during the examination period.
10.Those who have extremely little activity or exercise during the day.
11.Those who are unable to follow the schedule for EEG measurement and input into the daily logbook.
12.Participants who have participated in other research studies during the month prior to the date of consent, or who plan to participate in other research studies after consent for this study has been obtained.
13.Have traveled abroad within 2 weeks of the date of consent or plan to travel abroad during the study period.
14.Are breastfeeding, pregnant, or planning or wishing to become pregnant during the study period.
15.Those who are judged to be ineligible by the judgment of the supervising physician and principal investigator.
16.Those who use cosmetics for the purpose of relaxation or sleep improvement just before bedtime.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Kokubo |
Organization
S'UIMIN Corporation
Division name
Research Support Division
Zip code
151-0061
Address
817 Hatsudai Center Building, 1-51-1 Hatsudai, Shibuya-ku, Tokyo
TEL
+81-3-6276-3662
kokubo.toshio.fp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ohno |
Organization
Clinical Creative Co., Ltd.
Division name
Pharmaceutical Development Division
Zip code
062-0933
Address
1-12-102, Hiragishi 3-13-1-12, Toyohira-ku, Sapporo City, Hokkaido
TEL
09031166218
Homepage URL
k-ohno@cli-creative.com
Sponsor or person
Institute
Clinical Creative Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
S'UIMIN Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Yurinokai Hospital Clinical Trial Review Committee
Address
11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido
Tel
011-771-1501
info@yurinokai.jp
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
医療法人社団 札幌百合の会病院
Medical Corporation Association Sapporo Yurinokai Hospital
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 10 | Month | 05 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059833
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
