Back to resultsCatechin Containing Mask for the Prevention of Influenza Infection
Primary Purpose
Influenza Infection
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
tea catechin extracts
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Infection focused on measuring prophylaxis, influenza infection, catechins, prophylaxis of influenza infection
Eligibility Criteria
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
Sites / Locations
- Seirei Hamamatsu General Hospital
- University of Shizuoka
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tea catechin extracts containing mask
Arm Description
wearing the tea catechin extracts containing mask
Outcomes
Primary Outcome Measures
the incidence rate of influenza infection during the study
Secondary Outcome Measures
the incidence rates of upper respiratory tract infections
the severity of the symptoms and the duration of the cold among incident cases
he incidence-free time for influenza or upper respiratory tract infections after the intervention
Full Information
NCT ID
NCT00812448
First Posted
December 18, 2008
Last Updated
November 24, 2009
Sponsor
University of Shizuoka
Collaborators
Seirei Hamamatsu General Hospital, Hamamatsu University
1. Study Identification
Unique Protocol Identification Number
NCT00812448
Brief Title
Catechin Containing Mask for the Prevention of Influenza Infection
Official Title
The Effects of Tea Catechin Extracts Containing Mask on the Prevention of Influenza Infection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Shizuoka
Collaborators
Seirei Hamamatsu General Hospital, Hamamatsu University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Infection
Keywords
prophylaxis, influenza infection, catechins, prophylaxis of influenza infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tea catechin extracts containing mask
Arm Type
Experimental
Arm Description
wearing the tea catechin extracts containing mask
Intervention Type
Dietary Supplement
Intervention Name(s)
tea catechin extracts
Intervention Description
catechins are composed of tea catechin extracts available in grren tea supplements
Primary Outcome Measure Information:
Title
the incidence rate of influenza infection during the study
Time Frame
assessed at each month
Secondary Outcome Measure Information:
Title
the incidence rates of upper respiratory tract infections
Time Frame
assessed at each month
Title
the severity of the symptoms and the duration of the cold among incident cases
Time Frame
assessed at each month
Title
he incidence-free time for influenza or upper respiratory tract infections after the intervention
Time Frame
assessed at each month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroshi Yamada, MD,PhD
Organizational Affiliation
University of Shizuoka
Official's Role
Study Chair
Facility Information:
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
University of Shizuoka
City
Shizuoka
ZIP/Postal Code
422-8526
Country
Japan
12. IPD Sharing Statement
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Catechin Containing Mask for the Prevention of Influenza Infection
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