NCT00812448

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 26, 2009

Status Verified

November 1, 2009

Enrollment Period

11 months

First QC Date

December 18, 2008

Last Update Submit

November 24, 2009

Conditions

Influenza Infection

Keywords

prophylaxisinfluenza infectioncatechinsprophylaxis of influenza infection

Outcome Measures

Primary Outcomes (1)

  • the incidence rate of influenza infection during the study

    assessed at each month

Secondary Outcomes (3)

  • the incidence rates of upper respiratory tract infections

    assessed at each month

  • the severity of the symptoms and the duration of the cold among incident cases

    assessed at each month

  • he incidence-free time for influenza or upper respiratory tract infections after the intervention

    assessed at each month

Study Arms (1)

tea catechin extracts containing mask

EXPERIMENTAL

wearing the tea catechin extracts containing mask

Dietary Supplement: tea catechin extracts

Interventions

tea catechin extractsDIETARY_SUPPLEMENT

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

tea catechin extracts containing mask

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Location

University of Shizuoka

Shizuoka, Shizuoka, 422-8526, Japan

Location

Study Officials

  • Hiroshi Yamada, MD,PhD

    University of Shizuoka

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 22, 2008

Study Start

December 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations

JP(2)