Catechin Containing Mask for the Prevention of Influenza Infection
This study has been completed.
Sponsor:
University of Shizuoka
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
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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
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:
|
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 May 16, 2013