UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024920 |
|---|---|
| Receipt number | R000028668 |
| Scientific Title | Cross-sectional study of the relationship between the Shikohin-related behaviors and their psychological function. |
| Date of disclosure of the study information | 2016/12/02 |
| Last modified on | 2017/11/27 13:49:01 |
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Basic information
Public title
Cross-sectional study of the relationship between the Shikohin-related behaviors and their psychological function.
Acronym
Cross-sectional study of the relationship between the Shikohin-related behaviors and their psychological function.
Scientific Title
Cross-sectional study of the relationship between the Shikohin-related behaviors and their psychological function.
Scientific Title:Acronym
Cross-sectional study of the relationship between the Shikohin-related behaviors and their psychological function.
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the relationship between the Shikohin-related behaviors and their psychological function
Basic objectives2
Others
Basic objectives -Others
Analysis of the relationship between the Shikohin-related behaviors and their psychological function
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Shikohin-related behaviors
Key secondary outcomes
The psychological function of Shikohin-related behaviors
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criterion is daily consumption of at least one of four shikohin(alcohol, tea, coffee, and tobacco)
Key exclusion criteria
None
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kengo Yokomitsu |
Organization
Tobacco Academic Studies Center
Division name
Research Department
Zip code
Address
Toranomon No.30 Mori Bldg., 3-2-2, Toranomon, Minato-ku, Tokyo
TEL
03-3436-3780
yokomitsu@tasc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Yokomitsu |
Organization
Tobacco Academic Studies Center
Division name
Research Department
Zip code
Address
Toranomon No.30 Mori Bldg., 3-2-2, Toranomon, Minato-ku, Tokyo
TEL
03-3436-3780
Homepage URL
yokomitsu@tasc.or.jp
Sponsor or person
Institute
Tobacco Academic Studies Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku Gakuin University
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
首都圏１都３圏／the Tokyo metropolitan area (Tokyo, Kanagawa, Saitama, and Chiba)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 02 | 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
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
This survey is delivered to potential participants' homes and voluntarily return during the study period. Participants are selected through stratified two-stage random sampling with proportional allocation.
Management information
Registered date
| 2016 | Year | 11 | Month | 21 | Day |
Last modified on
| 2017 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028668
| 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 |
