UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052116 |
|---|---|
| Receipt number | R000059220 |
| Scientific Title | Effects of green tea gargling on coronavirus disease-2019: A randomized controlled trial |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2024/07/27 17:20:00 |
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Basic information
Public title
Effects of green tea gargling on coronavirus disease-2019: A randomized controlled trial
Acronym
Prevention of coronavirus disease-2019 by green tea gargling
Scientific Title
Effects of green tea gargling on coronavirus disease-2019: A randomized controlled trial
Scientific Title:Acronym
Prevention of coronavirus disease-2019 by green tea gargling
Region
| Japan |
Condition
Condition
coronavirus disease-2019
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of green tea gargling on preventing coronavirus disease-2019
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The occurrence of coronavirus disease-2019
Key secondary outcomes
(1)The occurrence of influenza
(2)The occurrence of upper respiratory tract infections
(3)Term from when clinical trial starts to when acute upper respiratory tract infections occur
(4)Severity of symptoms
(5)Number of occurrence
(6)Complications
(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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12 weeks,
Active drink, green tea
three times a day
Interventions/Control_2
12 weeks,
Control-drink, water
three times a day
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)18-70 years old, Men and women,
(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 dysphagia
(3)Having severe systemic chronic infectious diseases
(4)Subjects diagnosed by physicians inappropriate to participate in the study
Target sample size
1100
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
University of Shizuoka
Institute
Department
Personal name
Hiroshi Yamada
Funding Source
Organization
ITO EN, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Laboratory of Animal Physiology, School of Agriculture, Meiji University
Faculty of Medicine School of Health Science, Kagoshima University
White Cross Society
Seirei Hamamatsu General Hospital
Central Research Institute, ITO EN, Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the University of Shizuoka Research Ethics Committee
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）、鹿児島大学（鹿児島県）、白十字会（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 15 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059220
