Tokyo, Dec. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056518) titled 'Research on Stress Prediction Using a Tongue Imaging App' on Dec. 20.
Study Type:
Observational
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to explore the feasibility of using tongue images captured by a specialized app to predict stress levels in individuals.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Male and female aged over 20 years at the time of consent acquisition.
2. Individuals who are conscious of daily stress and are identified as experiencing stress via a web-based questionnaire at the time of consent.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria - 1. Individuals who regularly consume Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health foods (including supplements) with claims of reducing or alleviating stress and are unable to discontinue use from the time of consent.
2. Individuals taking medications that could affect the study, such as anxiolytics, antidepressants, sleeping pills, or sleep inducers.
3. Individuals diagnosed with or being treated for depression.
4. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
5. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
6. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
7. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target Size - 120
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 11 Month 19 Day
Date of IRB - 2024 Year 11 Month 15 Day
Anticipated trial start date - 2025 Year 01 Month 10 Day
Last follow-up date - 2025 Year 03 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063893
Disclaimer: Curated by HT Syndication.