UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046705 |
|---|---|
| Receipt number | R000053268 |
| Scientific Title | Study of inactivation of SARS-CoV-2 in saliva by ingestion of a candy containing tea-derived components in healthy adults |
| Date of disclosure of the study information | 2023/01/25 |
| Last modified on | 2023/01/25 09:31:41 |
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Basic information
Public title
Study of inactivation of SARS-CoV-2 in saliva by ingestion of a candy containing tea-derived components in healthy adults
Acronym
Study of inactivation of SARS-CoV-2 in saliva by candy containing tea-derived components
Scientific Title
Study of inactivation of SARS-CoV-2 in saliva by ingestion of a candy containing tea-derived components in healthy adults
Scientific Title:Acronym
Study of inactivation of SARS-CoV-2 in saliva by candy containing tea-derived components
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether the viral titer of saliva decreases by ingestion of a candy containing tea-derived components
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
viral titer of saliva
Key secondary outcomes
Tea-derived components concentration in saliva
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of candy A
Interventions/Control_2
Single ingestion of candy B
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women between the ages of 20 and 65 at the time of obtaining the consent document for participation in the exam.
(2) Those who have received sufficient explanation about the purpose and contents of this study, have the ability to consent, voluntarily apply for participation after understanding it well, and can consent to participate in this study in writing.
Key exclusion criteria
(1) Persons suffering from severe liver disorder, cardiovascular disorder, respiratory disorder, endocrine disorder, metabolic disorder
(2) Those who may have an allergic reaction to the test meal
(3) Those who are pregnant, breastfeeding, or willing to become pregnant during the test period
(4) Those with irregular menstrual cycles
(5) Persons with extremely irregular eating habits, shift workers, late-night workers
(6)Subjects who are attending other studies or attended other studies within the past 3 months.
(7) Persons who regularly use pharmaceuticals (including Chinese herbs) or supplements
(8) Those who do not agree with the purpose of the explanation of this study conducted in advance
(9) Others who are judged by the investigator to be inappropriate for this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Matsuda |
Organization
Kyoto prefectural university of medicine
Division name
Department of immunology
Zip code
602-8566
Address
465, kajii-cho, kawaramachihirokoji, kamigyo-ku, Kyoto, 602-8566, Japan
TEL
0752515330
mazda@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kobayashi |
Organization
ITO EN, Ltd.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL
0548541247
Homepage URL
m-kobayasi@itoen.co.jp
Sponsor or person
Institute
Kyoto prefectural university of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Ethnical Review Board
Address
465, kajii-cho, kawaramachihirokoji, kamigyo-ku, Kyoto, 602-8566, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 25 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053268
