Catechin Containing Mask for the Prevention of Influenza Infection

November 24, 2009 updated by: University of Shizuoka

The Effects of Tea Catechin Extracts Containing Mask on the Prevention of Influenza Infection

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Shizuoka, Japan, 422-8526
        • University of Shizuoka
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan
        • Seirei Hamamatsu General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tea catechin extracts containing mask
wearing the tea catechin extracts containing mask
Dietary supplement: tea catechin extracts
catechins are composed of tea catechin extracts available in grren tea supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence rate of influenza infection during the study
Time Frame: assessed at each month
assessed at each month

Secondary Outcome Measures

Outcome Measure
Time Frame
the incidence rates of upper respiratory tract infections
Time Frame: assessed at each month
assessed at each month
the severity of the symptoms and the duration of the cold among incident cases
Time Frame: assessed at each month
assessed at each month
he incidence-free time for influenza or upper respiratory tract infections after the intervention
Time Frame: assessed at each month
assessed at each month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Shizuoka

Collaborators

Hamamatsu University
Seirei Hamamatsu General Hospital

Investigators

  • Study Chair: Hiroshi Yamada, MD,PhD, University of Shizuoka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

November 26, 2009

Last Update Submitted That Met QC Criteria

November 24, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT2009001
  • 20-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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