UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the scale of the function of the involuntary autobiographical memory cued by consuming Shikohin
Title of the study (Brief title)	Development of the scale of the function of the involuntary autobiographical memory cued by consuming Shikohin
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to develop the scale of the function of the autobiographical memory cued by consuming Shikohin
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to develop the scale of the function of the autobiographical memory cued by consuming Shikohin
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the function of the autobiographical memory cued by consuming Shikohin
Key secondary outcomes

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	59 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	Kohsuke Yamamoto
Organization	Osaka Sangyo University
Division name	Faculty of International Studies
Address	3-1-1, Nakagaito,Daito,Osaka
TEL	072-875-3001
Email	kyamamoto@int.osaka-sandai.ac.jp

Public contact
Name of contact person	Kohsuke Yamamoto
Organization	Osaka Sangyo University
Division name	Faculty of International Studies
Address	3-1-1, Nakagaito,Daito,Osaka
TEL	072-875-3001
Homepage URL
Email	kyamamoto@int.osaka-sandai.ac.jp

Sponsor
Institute	Osaka Sangyo University
Institute
Department

Funding Source
Organization	Tobacco Academic Research Center
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tobacco Academic Research Center
Name of secondary funｄer(s)	none

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	2017 Year 10 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 28 Day
Anticipated trial start date	2017 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	internet survey

Management information
Registered date	2017 Year 10 Month 10 Day
Last modified on	2017 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033689