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Catechin Gargling for Influenza Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00239213
First Posted: October 14, 2005
Last Update Posted: October 31, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Shizuoka General Hospital
Seirei Hamamatsu General Hospital
White Cross Nursing Home
Information provided by:
University of Shizuoka
  Purpose
The purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection.

Condition Intervention
Influenza Infection Drug: catechin extracts (health food)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Shizuoka:

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

Secondary Outcome Measures:
  • severity of symptoms including complications and hospitalization

Estimated Enrollment: 400
Study Start Date: November 2005
Estimated Study Completion Date: April 2006
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.
  Eligibility

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 Submitted: October 13, 2005
First Posted: October 14, 2005
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