Catechin Containing Mask for the Prevention of Influenza Infection

Influenza Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812448
• Other study ID #: CT2009001
• Secondary ID: 20-24
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: November 24, 2009
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: University of Shizuoka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza Infection
• Influenza, Human

Intervention

Dietary Supplement:
• tea catechin extracts
catechins are composed of tea catechin extracts available in grren tea supplements

Locations

Country	Name	City	State
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	University of Shizuoka	Shizuoka

Sponsors (3)

Lead Sponsor	Collaborator
University of Shizuoka	Hamamatsu University, Seirei Hamamatsu General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence rate of influenza infection during the study		assessed at each month	No
Secondary	the incidence rates of upper respiratory tract infections		assessed at each month	No
Secondary	the severity of the symptoms and the duration of the cold among incident cases		assessed at each month	No
Secondary	he incidence-free time for influenza or upper respiratory tract infections after the intervention		assessed at each month	No