Catechin Gargling for Influenza Infection

This study has been completed.
Sponsor:
Collaborators:
Shizuoka General Hospital
Seirei Hamamatsu General Hospital
White Cross Nursing Home
Information provided by:
University of Shizuoka
ClinicalTrials.gov Identifier:
NCT00239213
First received: October 13, 2005
Last updated: October 28, 2006
Last verified: October 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00239213     History of Changes
Other Study ID Numbers: CT2005002
Study First Received: October 13, 2005
Last Updated: October 28, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 18, 2014