UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048124 |
|---|---|
| Receipt number | R000054049 |
| Scientific Title | Estimation of anti-SARS-CoV-2 effect in saliva from healthy individuals who ingest candies containing tea-derived components |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2022/06/21 17:47:01 |
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Basic information
Public title
Estimation of anti-SARS-CoV-2 effect in saliva from healthy individuals who ingest candies containing tea-derived components
Acronym
Anti-SARS-CoV-2 effect in saliva from healthy individuals who ingest candies containing tea-derived components
Scientific Title
Estimation of anti-SARS-CoV-2 effect in saliva from healthy individuals who ingest candies containing tea-derived components
Scientific Title:Acronym
Anti-SARS-CoV-2 effect in saliva from healthy individuals who ingest candies containing tea-derived components
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate SARS-CoV-2 inactivation effect in saliva from healthy individuals who ingest candies containing tea-derived components
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Viral inactivation effects in saliva before ingestion of a candy containing tea-derived components and 0, 5 and 15 min after cessation of the candy ingestion.
Key secondary outcomes
Concentrations of catechin-related components in the saliva before ingestion of a candy containing tea-derived components and 0, 5 and 15 min after cessation of the candy ingestion. And viral RNA levels of SARS-CoV-2 treated with the saliva samples.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of a candy containing green tea for 5 minutes
Interventions/Control_2
Ingestion of a candy containing black tea for 5 minutes
Interventions/Control_3
Ingestion of a candy containing neither green tea nor black tea for 5 minutes
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 volunteers who has no symptoms and do not receive an administration of immunosuppressants including corticosteroid.
2. Patients who voluntarily participate in the study and give written consent.
3. Patients aged 20 years old or above and 75 years old or younger at the time of consent.
Key exclusion criteria
1. Patients with severe disease (inducing patients who receive an administration of immunosuppressants including corticosteroid).
2. Patients with history of either liver or kidney disease.
3. Patients allergic for either tea or catechins.
4. Patients whom the doctor in attendance considers inadequate for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osam |
| Middle name | |
| Last name | Mazda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Immunology
Zip code
602-8566
Address
Kajiicho, Kawaramachi-Hirokoji, Kamigyo, Kyoto, Japan
TEL
+81-75-251-5330
mazda@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osam |
| Middle name | |
| Last name | Mazda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Immunology
Zip code
602-8566
Address
Kajiicho, Kawaramachi-Hirokoji, Kamigyo, Kyoto, Japan
TEL
+81-75-251-5330
Homepage URL
mazda@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
ITO EN Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
Address
Kajiicho, Kawaramachi-Hirokoji, Kamigyo, Kyoto, Japan
Tel
81-75-251-5330
mazda@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
| 2025 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 21 | Day |
Last modified on
| 2022 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054049
