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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012941
Receipt No. R000015140
Scientific Title Effect of epigallocatechin on antibody-producing ability and immunostimulatory activity after influenza vaccination
Date of disclosure of the study information 2014/01/24
Last modified on 2014/01/24

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Basic information
Public title Effect of epigallocatechin on antibody-producing ability and immunostimulatory activity after influenza vaccination
Acronym Epigallocatechin and immune response to influenza vaccination
Scientific Title Effect of epigallocatechin on antibody-producing ability and immunostimulatory activity after influenza vaccination
Scientific Title:Acronym Epigallocatechin and immune response to influenza vaccination
Region
Japan

Condition
Condition Influenza infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of epigallocatechin on the antibody-producing ability after influenza vaccination
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Influenza antibody titers ability after influenza vaccination
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Take epigallocatechin-supplemented(100mg/day) barely tea for 4 months in subjects greater than 65 years
Interventions/Control_2 Take placebo-added barely tea for 4 months in subjects greater than 65 years
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria subjects in the Aiwa geriatric health services facilities
Key exclusion criteria poorly or un-controlled abnormality in glucose metabolism
terminal-phase malignancies
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokuni Negishi
Organization Aiwakai Social Welfare Corporation
Division name chief director
Zip code
Address Terauchi 1-1-10 Toyonaka-shi Osaka Japan
TEL 06-6866-2941
Email hirokuni@db3.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokuni Negishi
Organization Aiwakai Social Welfare Corporation
Division name chief director
Zip code
Address Terauchi 1-1-10 Toyonaka-shi Osaka Japan
TEL 06-6866-2941
Homepage URL
Email hirokuni@db3.so-net.ne.jp

Sponsor
Institute Aiwakai Social Welfare Corporation
Institute
Department

Funding Source
Organization Agriculture-Medicine cooperation project
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2014 Year 01 Month 24 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
2011 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 08 Day
Last follow-up date
2012 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 24 Day
Last modified on
2014 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015140

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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