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Catechin Gargling for Influenza Infection

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ClinicalTrials.gov Identifier: NCT00239213
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : October 31, 2006
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection.

Condition or disease Intervention/treatment
Influenza Infection Drug: catechin extracts (health food)

Detailed Description:
In-vitro experimental studies have revealed that tea catechin extracts induce preventive effects on influenza infection. However, few studies have been conducted on the effects of tea gargling on influenza infection, and the clinical evidence is unclear. Also there have been no studies reported on the gargling effects with tea catechin extracts on the prevention of influenza infection.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized Clinical Study of Catechin Gargling Effects on the Prevention of Influenza Infection
Study Start Date : November 2005
Estimated Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Cianidanol
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Incidence rates of influenza infection during the study

Secondary Outcome Measures :
  1. severity of symptoms including complications and hospitalization

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers
  • aged 20 to 65 years old
  • obtained written informed concent before participation
  • inoculated with influenza vaccine before entering the study

Exclusion Criteria:

  • other gargling except water during the study
  • possessing tea allergy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239213


Locations
Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan, 430-8558
White Cross Nursing Home
Higashi Murayama, Tokyo, Japan, 189-0021
Shizuoka General Hospial
Shizuoka, Japan, 420-8527
Sponsors and Collaborators
University of Shizuoka
Shizuoka General Hospital
Seirei Hamamatsu General Hospital
White Cross Nursing Home
Investigators
Principal Investigator: Hiroshi Yamada, MD, PhD University of Shizuoka
More Information

ClinicalTrials.gov Identifier: NCT00239213     History of Changes
Other Study ID Numbers: CT2005002
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: October 31, 2006
Last Verified: October 2006

Keywords provided by University of Shizuoka:
catechins
gargling
healthy volunteers

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases