UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024362 |
|---|---|
| Receipt number | R000028045 |
| Scientific Title | Effects of catechin-derivative-treated masks on the prevention of influenza infection: an exploratory randomized study |
| Date of disclosure of the study information | 2016/10/14 |
| Last modified on | 2020/01/21 09:46:30 |
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Basic information
Public title
Effects of catechin-derivative-treated masks on the prevention of influenza infection: an exploratory randomized study
Acronym
Effects of catechin-derivative-treated masks on the prevention of influenza infection
Scientific Title
Effects of catechin-derivative-treated masks on the prevention of influenza infection: an exploratory randomized study
Scientific Title:Acronym
Effects of catechin-derivative-treated masks on the prevention of influenza infection
Region
| Japan |
Condition
Condition
Influenza infection
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects catechin-derivative-treated masks on the prevention of influenza infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence rate of influenza-like illness during the study period
Key secondary outcomes
1)Incidence rate of laboratory-confirmed influenza A or B virus infection
2)Incidence rate of laboratory-confirmed influenza infection or influenza-like illness
3)Incidence rate of acute upper respiratory tract infection
4)Mask-wearing rate
5)Incidence of adverse device effect and defect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Catechin-derivative-treated mask/60 days
Interventions/Control_2
Non-catechin-derivative-treated mask/60 days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Written informed consent obtained before participation
2)Aged 20 years old or older
3)Opportunity to interact with influenza infected subjects
4)Willing and able to wear masks during the study period
5)Willing and able to fill out questionnaires
Key exclusion criteria
1)Green tea allergy
2)Allergy to mask material
3)Severe immune disease
4)Chronic systemic infectious disease
5)History of influenza infection within the previous 6 months and influenza infection within 24 hours after participation
6)Subjects diagnosed by a physician inappropriate to participate in the study
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka, Japan
TEL
+81-54-264-5762
hyamada@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka, Japan
TEL
+81-54-264-5762
Homepage URL
http://u-shizuoka-ken.ac.jp
hyamada@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
White Cross Nursing Home
Osaka University
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
静岡県立大学（静岡県）/University of Shizuoka(Shizuoka)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028045
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| Registered date | File name |
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| Registered date | File name |
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