UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026027 |
|---|---|
| Receipt number | R000029917 |
| Scientific Title | The effect verification examination by continuous use of bath additives |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2017/07/18 13:33:06 |
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Basic information
Public title
The effect verification examination by continuous use of bath additives
Acronym
The continuous use examination of bath additives
Scientific Title
The effect verification examination by continuous use of bath additives
Scientific Title:Acronym
The continuous use examination of bath additives
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test soothing effect from fatigue by continuous use of bath additives
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of fatigue, sleep, body composition, an autonomic nerve function, a vascular function, and blood composition before use of bath additives and after continuous use for 2 and 4 weeks
Key secondary outcomes
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
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Bathe with bath additives A for 10 minutes once a day for 4 weeks
Interventions/Control_2
Bathe with bath additives B for 10 minutes once a day for 4 weeks
Interventions/Control_3
Bathe with bath additives C for 10 minutes once a day for 4 weeks
Interventions/Control_4
Bathe with tap water for 10 minutes once a day for 4 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy females
Key exclusion criteria
(1) Subjects who has a cutaneous symptom which affects the final examination in the body
(2) Subjects who are using the drugs which may influence an examination
(3) Subjects (except for dental care) under a therapy or going to hospital regularly due to sick.
(4) Subjects who has pollinosis
(5) Subjects past menopause
(6) Subjects under pregnancy or who may have been conceived, and breast-feeding
(7) Subjects who has participated in other clinical trials
(8) Subjects judged that a test implementation person in charge is unsuitable
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Takashima |
Organization
INFORWARD inc.
Division name
EBISU Skin research center
Zip code
Address
1-11-2 5F, Ebisu Shibuya-ku, Tokyo, 150-0013, JAPAN
TEL
03-5793-8712
takashima@inforward.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Takashima |
Organization
INFORWARD inc.
Division name
EBISU Skin research center
Zip code
Address
1-11-2 5F, Ebisu Shibuya-ku, Tokyo, 150-0013, JAPAN
TEL
03-5793-8712
Homepage URL
takashima@inforward.co.jp
Sponsor or person
Institute
INFORWARD inc.
EBISU Skin research center
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
株式会社インフォワード恵比寿スキンリサーチセンター（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | 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
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 07 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 07 | Day |
Last modified on
| 2017 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029917
| Research Plan | |
|---|---|
| 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 |
