Catechin Containing Mask for the Prevention of Influenza Infection - Full Text View

Sponsors and Collaborators:	University of Shizuoka Seirei Hamamatsu General Hospital Hamamatsu University
Information provided by:	University of Shizuoka
ClinicalTrials.gov Identifier:	NCT00812448

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

MedlinePlus related topics: Dietary Supplements Flu

Drug Information available for: Epigallocatechin gallate Catechin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effects of Tea Catechin Extracts Containing Mask on the Prevention of Influenza Infection

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 ]

Estimated Enrollment:	160
Study Start Date:	December 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
tea catechin extracts containing mask: Experimental 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

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

Contacts

Contact: Hiroshi Yamada, MD,PhD	+81 54 264 5762	hyamada@u-shizuoka-ken.ac.jp
Contact: Kazuhiro Kosuge, PhD	+81 54 564 5770	kosuge@u-shizuoka-ken.ac.jp

Locations

Japan
University of Shizuoka	Recruiting
Shizuoka, Japan, 422-8526
Contact: Kazuhiro Kosuge, PhD +81 54 264 5770 kosuge@u-shizuoka-ken.ac.jp
Principal Investigator: Hiroshi Yamada, MD,PhD
Japan, Shizuoka
Seirei Hamamatsu General Hospital	Recruiting
Hamamatsu, Shizuoka, Japan
Contact: Mizuo Kimata 81 53 474 1264 m-kimata@sis.seirei.or.jp
Principal Investigator: Masayuki Yoshida, MD,PhD

Sponsors and Collaborators

University of Shizuoka

Seirei Hamamatsu General Hospital

Hamamatsu University

Investigators

Study Chair:

Hiroshi Yamada, MD,PhD

University of Shizuoka

More Information

Responsible Party:	University of Shizuoka ( Hiroshi Yamada/Professor )
Study ID Numbers:	20-24, 20-24
Study First Received:	December 18, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00812448
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Shizuoka:

prophylaxis
influenza infection
catechins
prophylaxis of influenza infection

Study placed in the following topic categories:

Virus Diseases
Epigallocatechin gallate
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Anticarcinogenic Agents
Communicable Diseases
RNA Virus Infections
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Antimutagenic Agents
Infection
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009