Catechin Containing Mask for the Prevention of Influenza Infection

Not Applicable

Completed

• Conditions: Influenza Infection

• Registration Number: NCT00812448
• Lead Sponsor: University of Shizuoka

Brief Summary

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

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Status Verified: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-24
• Last Update Posted: 2009-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the incidence rate of influenza infection during the study	assessed at each month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Seirei Hamamatsu General Hospital; 🇯🇵 Hamamatsu, Shizuoka, Japan

University of Shizuoka; 🇯🇵 Shizuoka, Japan