Tokyo, Feb. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060519) titled 'Effects of wearing test products on blood flow' on Feb. 8.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Miura Clinic, Medical Corporation Kanonkai
Condition:
Condition - Healthy males and females
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluation the effects of wearing test products on blood flow in healthy adult males and females
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Wearing test products
Interventions/Control_2 - Wearing placebo products
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Healthy males and females from 20 to 64 years old
(2) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria - (1) Subjects with a history of mental illness, diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease.
(2) Subjects who have undergone gastrointestinal surgery
(3) Subjects with abnormal liver or kidney function tests
(4) Subjects with currently treated medical conditions
(5) Subjects who are allergic to food and drugs
(6) Subjects with anemia symptoms
(7) Female participants wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female participants
(8) Subjects who play intense sports and subjects who are on a diet
(9) Subjects with extremely irregular lifestyles
(10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(11) Subjects who are continuously receiving treatment with pharmaceuticals (including OTC and prescription drugs)
(12) Subjects who drink exceed 40 g of average pure daily alcohol
(13) Subjects who smoke an average of 21 or more cigarettes a day
(14) Subjects who are participating in or will participate in other clinical trials at the start of this study
(15) Others, subjects judged by the principal investigator or the co-investigator to be inappropriate for the examination
Target Size - 16
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 16 Day
Date of IRB - 2026 Year 01 Month 29 Day
Anticipated trial start date - 2026 Year 02 Month 09 Day
Last follow-up date - 2026 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069190
Disclaimer: Curated by HT Syndication.