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
  Purpose

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


Condition Intervention
Influenza Infection
Dietary Supplement: tea catechin extracts

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Tea Catechin Extracts Containing Mask on the Prevention of Influenza Infection

Resource links provided by NLM:


Further study details as provided by University of Shizuoka:

Primary Outcome Measures:
  • the incidence rate of influenza infection during the study [ Time Frame: assessed at each month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 180
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tea catechin extracts containing mask
wearing the tea catechin extracts containing mask
Dietary Supplement: tea catechin extracts
catechins are composed of tea catechin extracts available in grren tea supplements

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812448

Locations
Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
University of Shizuoka
Shizuoka, Japan, 422-8526
Sponsors and Collaborators
University of Shizuoka
Seirei Hamamatsu General Hospital
Hamamatsu University
Investigators
Study Chair: Hiroshi Yamada, MD,PhD University of Shizuoka
  More Information

No publications provided

Responsible Party: Hiroshi Yamada/Professor, University of Shizuoka
ClinicalTrials.gov Identifier: NCT00812448     History of Changes
Other Study ID Numbers: CT2009001, 20-24
Study First Received: December 18, 2008
Last Updated: November 24, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Shizuoka:
prophylaxis
influenza infection
catechins
prophylaxis of influenza infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014