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Catechin Containing Mask for the Prevention of Influenza Infection

NCT ID: NCT00812448

Last Updated: 2009-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to evaluate the effects of catechin extracts containing mask on prevention of influenza infection.

Detailed Description

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Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent in-vitro experimental studies have revealed that tea catechin extracts possess the effects on the prevention of influenza infection. However, a limited number of studies have been conducted on the clinical effects. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of tea catechin extracts containing mask on the prevention of influenza infection.

Conditions

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Influenza Infection

Keywords

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prophylaxis influenza infection catechins prophylaxis of influenza infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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tea catechin extracts containing mask

wearing the tea catechin extracts containing mask

Group Type EXPERIMENTAL

tea catechin extracts

Intervention Type DIETARY_SUPPLEMENT

catechins are composed of tea catechin extracts available in grren tea supplements

Interventions

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tea catechin extracts

catechins are composed of tea catechin extracts available in grren tea supplements

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Possible to wearing mask for three months
* Possible to fill out a questionnaire personally
* Obtained written informed consent before participation

Exclusion Criteria

* Possessing some infectious diseases in need of therapy
* Possessing tea or catechin allergy
* diagnosed as inadequate for other reasons to participate the study by principal investigator
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seirei Hamamatsu General Hospital

OTHER

Sponsor Role collaborator

Hamamatsu University

OTHER

Sponsor Role collaborator

University of Shizuoka

OTHER

Sponsor Role lead

Responsible Party

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University of Shizuoka

Principal Investigators

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Hiroshi Yamada, MD,PhD

Role: STUDY_CHAIR

University of Shizuoka

Locations

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Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Site Status

University of Shizuoka

Shizuoka, Shizuoka, Japan

Site Status

Countries

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Japan

Other Identifiers

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20-24

Identifier Type: -

Identifier Source: secondary_id

CT2009001

Identifier Type: -

Identifier Source: org_study_id