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Catechin Containing Mask for the Prevention of Influenza Infection

This study has been completed.
Sponsor:
Collaborators:
Seirei Hamamatsu General Hospital
Hamamatsu University
Information provided by:
University of Shizuoka
ClinicalTrials.gov Identifier:
NCT00812448
First received: December 18, 2008
Last updated: November 24, 2009
Last verified: November 2009
History of Changes

December 18, 2008
November 24, 2009
December 2008
November 2009   (final data collection date for primary outcome measure)
the incidence rate of influenza infection during the study [ Time Frame: assessed at each month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00812448 on ClinicalTrials.gov Archive Site
  • the incidence rates of upper respiratory tract infections [ Time Frame: assessed at each month ] [ Designated as safety issue: No ]
  • the severity of the symptoms and the duration of the cold among incident cases [ Time Frame: assessed at each month ] [ Designated as safety issue: No ]
  • he incidence-free time for influenza or upper respiratory tract infections after the intervention [ Time Frame: assessed at each month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Catechin Containing Mask for the Prevention of Influenza Infection
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza Infection
Dietary Supplement: tea catechin extracts
catechins are composed of tea catechin extracts available in grren tea supplements
Experimental: tea catechin extracts containing mask
wearing the tea catechin extracts containing mask
Intervention: Dietary Supplement: tea catechin extracts
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00812448
CT2009001, 20-24
No
Hiroshi Yamada/Professor, University of Shizuoka
University of Shizuoka
  • Seirei Hamamatsu General Hospital
  • Hamamatsu University
Study Chair: Hiroshi Yamada, MD,PhD University of Shizuoka
University of Shizuoka
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP