UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012941
Receipt number 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 15:57:01

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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 or person

Institute

Aiwakai Social Welfare Corporation

Institute

Department

Personal name



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

Value
https://center6.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