UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016253 |
|---|---|
| Receipt number | R000018859 |
| Scientific Title | The chronic effects of bath agents on the sleep, mental conditions and working efficiency of healthy young persons |
| Date of disclosure of the study information | 2015/01/18 |
| Last modified on | 2015/01/19 15:13:31 |
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Basic information
Public title
The chronic effects of bath agents on the sleep, mental conditions and working efficiency of healthy young persons
Acronym
The chronic effects of bath agents on the sleep, mental conditions and working efficiency
Scientific Title
The chronic effects of bath agents on the sleep, mental conditions and working efficiency of healthy young persons
Scientific Title:Acronym
The chronic effects of bath agents on the sleep, mental conditions and working efficiency
Region
| Japan |
Condition
Condition
healthy young persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of bath agents on the sleep, mental conditions and working efficiency
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS,SDS,Apathy scale,Miyake paired verbal association learning test,Rey-Osterrieth
Complex Figure,actigraph,A-MES
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
bath agents(sodium sulfate,sodium hydrogen carbonate,sodium carbonate,malic acid),each night for 14 consecutive nights
Interventions/Control_2
bath agents(sodium sulfate,sodium hydrogen carbonate,sodium carbonate),each night for 14 consecutive nights
Interventions/Control_3
tap water,each night for 14 consecutive nights
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
| 19 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy young persons
Key exclusion criteria
orthostatic hypotension, skin disease, acute disease, active tuberculosis, malignant tumors, heart disease, respiratory failure, renal failure, bleeding disease, severe anemia, pregnancy, arteriosclerosis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun-ich Iiyama |
Organization
Kumamoto Health Science University
Division name
Department of Rehabilitation
Zip code
Address
325 Izumi-machi, Kita-ku, Kumamoto 861-5598, Japan
TEL
096-275-2111
iiyama@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Kubo |
Organization
Kumamoto Health Science University
Division name
Department of Rehabilitation
Zip code
Address
325 Izumi-machi, Kita-ku, Kumamoto 861-5598, Japan
TEL
096-275-2111
Homepage URL
kubo@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Bathclin 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 18 | 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
| 2014 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 29 | 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
| 2015 | Year | 01 | Month | 18 | Day |
Last modified on
| 2015 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018859
