Tokyo, Aug. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058836) titled 'Effects of wearing a test substance that generates far-infrared rays and weak electric currents on concentration and physical range of motion' on Aug. 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Japan Clinical Trial Association
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluating the effects of wearing test products on concentration and physical range of motion
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - For concentration assessment, the hat-type device (test product) was worn once, and for range of motion assessment, the ankle band-type device (test product) was worn for two weeks.
Interventions/Control_2 - For concentration assessment, the hat-type device (placebo) was worn once, and for range of motion assessment, the ankle band-type device (placebo) was worn for two weeks.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Subjects who suffer from fatigue, stiff shoulders, or lower back pain
2.Subjects who feel a decline in concentration or find it difficult to focus
Key exclusion criteria - 1. Subjects with a history of treatment that may have affected the test site.
2. Subjects with color vision deficiency (reduced color perception).
3. Subjects unable to wash the test product.
4. Subjects who have started taking a new medication within the past two months.
5. Subjects currently attending chiropractic clinics, gyms, or yoga classes.
6. Subjects planning to change their lifestyle during the study period.
7. Subjects who have participated in or plan to participate in other clinical trials within the past month prior to consent acquisition.
8. Subjects who are currently pregnant or breastfeeding (including those who have recently given birth).
9. Subjects with alcoholism or heavy smokers.
10. Subjects with a history of food or contact allergies.
11. Subjects receiving hormone replacement therapy.
12. Subjects unable to walk independently without assistance.
13. Subjects suspected of mild or severe dementia.
14. Subjects deemed inappropriate by the principal investigator.
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Date of IRB - 2025 Year 07 Month 10 Day
Anticipated trial start date - 2025 Year 08 Month 20 Day
Last follow-up date - 2025 Year 09 Month 10 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067278
Disclaimer: Curated by HT Syndication.