UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045060 |
|---|---|
| Receipt number | R000051476 |
| Scientific Title | Prevention of acute upper respiratory tract inflammation by green tea gargling: concentration-dependent effects in a randomized controlled trial |
| Date of disclosure of the study information | 2021/08/05 |
| Last modified on | 2022/08/26 16:51:09 |
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Basic information
Public title
Prevention of acute upper respiratory tract inflammation by green tea gargling: concentration-dependent effects
Acronym
Prevention of acute upper respiratory tract inflammation by green tea gargling
Scientific Title
Prevention of acute upper respiratory tract inflammation by green tea gargling: concentration-dependent effects in a randomized controlled trial
Scientific Title:Acronym
Prevention of acute upper respiratory tract inflammation by green tea gargling
Region
| Japan |
Condition
Condition
Acute upper respiratory tract inflammation
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the concentration dependent effects of green tea gargling on the incidence of acute upper respiratory tract inflammation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1 The occurrence of acute upper respiratory tract inflammation.
Key secondary outcomes
1 The occurrence of influenza
2 The occurrence of SARS COVID-2
3 Term from when clinical trial starts to when acute upper respiratory tract inflammation occurs
4 Severity of symptoms
5 Number of occurrences
6 Complication such as pneumonia and encephalopathy or hospitalization
7 Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12 weeks,
Active drink, green tea including high catechin concentration
three times a day
Interventions/Control_2
12 weeks,
Active drink, green tea including low catechin concentration,
three times a day
Interventions/Control_3
12 weeks,
Control-drink, water
three times a day
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women, high school/university students
(2) Able to give written informed consent
(3) Able to gargle and
to write questionnaire
Key exclusion criteria
(1) Potentially having the allergy to green tea
(2) Having severe systemic chronic infectious diseases
(3) Subjects diagnosed by physicians inappropriate to participate in the study
Target sample size
405
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
+81-54-264-5762
hyamada@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
+81-54-264-5762
Homepage URL
http://u-shizuoka-ken.ac.jp
hyamada@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Department of Drug Evaluation and Information Graduate School of Pharmaceutical Science, University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Laboratory of Animal Physiology, School of Agriculture, Meiji University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of the University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel
054-264-5103
rinri@u-shizuoka-ken.ac.jp
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）、明治大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
209
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 04 | Day |
Last modified on
| 2022 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051476
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
