Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000048124) titled 'Estimation of anti-SARS-CoV-2 effect in saliva from healthy individuals who ingest candies containing tea-derived components' on Dec. 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kyoto Prefectural University of Medicine
Condition:
Condition - Healthy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To estimate SARS-CoV-2 inactivation effect in saliva from healthy individuals who ingest candies containing tea-derived components
Basic objectives2 - Pharmacodynamics
Intervention:
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
Eligibility:
Age-lower limit - 20
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 Size - 30
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054049
Disclaimer: Curated by HT Syndication.