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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005356
Receipt No. R000006358
Scientific Title Epidemiological study on herpes zoster
Date of disclosure of the study information 2011/03/31
Last modified on 2014/03/26

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Basic information
Public title Epidemiological study on herpes zoster
Acronym Epidemiological study on herpes zoster
Scientific Title Epidemiological study on herpes zoster
Scientific Title:Acronym Epidemiological study on herpes zoster
Region
Japan

Condition
Condition herpes zoster
Classification by specialty
Infectious disease Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To collect epidemiological findings of herpes zoster and review factors of its pathogenesis
Basic objectives2 Others
Basic objectives -Others -The incidence of herpes zoster.
-Severity and duration of pain.
-Relationships of the incidence with lifestyle and sociopsychological factors.
-Relationships of the incidence with the state of cell-mediated immunity (CMI) and humoral immunity.
-Relationships of the cell-mediated immunity and the humoral-mediated immunity.
-Duration of CMI and humoral immunity.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes -The number of patients developed herpes zoster
-Degree of pain by 6-level face scale
-Duration of pain
-Health questionnaire of 31 items
-Level of cell-mediated immunity by varicella intradermal skin test (at baseline, 1 year later, 2 years later and 3 years later)
-Level of cell-mediated immunity by ELISPOT (at baseline, 1 year later, 2 years later, 3 years later, in onset and at the recovery)
-Level of humoral immunity by gp-ELISA, IAHA and NT (at baseline, 1 year later, 2 years later, 3 years later, in onset and at the recovery)
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Those who meet the following requirements as of October 1st, 2008. There is no upper age limit.
Subject A : 50 or older
Subject B : 50 or older
Subject C : 60 or older
Subject C' : 60 or older
2.Those who possess Japanese citizenship and live in Shozu, Kagawa as of October 1st, 2008.
3.Those who give consent in writing to cooperate on this study.
Key exclusion criteria Participants enrolled in Subject B, C or C' may not be accepted, if they meet the following items on the day varicella intradermal skin reaction is evaluated.

1.Those who with epidemic dermatosis.
2.Other than above, those who are not suitable for varicella intradermal skin test or blood sampling.

Some participants may not be enrolled when the organizers consider they are inappropriate even they meet the above criteria.
Target sample size 12000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Yamanishi
Organization National Institute of Biomedical Innovation
Division name Director General
Zip code
Address 7-6-8 Saito Asagi Ibaraki-City Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kimihiko Yoshii
Organization National Institute of Biomedical Innovation
Division name Department of Strategic Planning
Zip code
Address 7-6-8 Asagi Saito Ibaraki-City Osaka
TEL 072-641-9832
Homepage URL
Email k-yoshii@nibio.go.jp

Sponsor
Institute National Institute of Biomedical Innovation
Institute
Department

Funding Source
Organization Japan Health Sciences Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The Research Foundation for Microbial Diseases of Osaka University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2013 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 31 Day
Last modified on
2014 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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