Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059074) titled 'Verification of the Muscle Relaxation Effect of Palm G-Point Stimulation Using a Developed Stimulation Device' on Sept. 12.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - LEMON inc.

Condition: Condition - Healthy adults and older adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to verify, through a crossover design, whether stimulation of the G-point on the palm using a stimulation device (grip) developed as a health device can bring about a muscle relaxation effect. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Developed stimulation device (stimulation) - Washout - Dummy device (no stimulation) Interventions/Control_2 - Dummy device (no stimulation) - Washout - Developed stimulation device (stimulation)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Healthy Japanese males and females who are aged 20 to under 70 years at the time of written informed consent. 2. Subjects who have been fully informed the purpose and details of the study, have the ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing. Subjects who bend forward and cannot firmly touch the front of their palms to the floor. 3. Subjects who can come to the facility on the designated test date and take the test. 4. Subjects who bend forward and cannot firmly touch the front of their palms to the floor. 5. Subjects who are healthy enough to exercise. Key exclusion criteria - 1.Subjects with chronic diseases associated with exercise restrictions, or those currently receiving treatment for any diseases. 2.Subjects with a history or current diagnosis of chronic fatigue syndrome with exercise restrictions, psychiatric disorders, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases. 3.Subjects with a history or current diagnosis of low back pain or spinal disorders (e.g., herniated disc, spinal canal stenosis). 4.Subjects with a history or current diagnosis of severe cardiovascular, respiratory, hepatic, renal, hematologic, or gastrointestinal disorders that may adversely affect health during exercise. 5.Subjects with severe anemia. 6.Subjects who have continuously used medications (oral or topical) for disease treatment within the past month. 7.Subjects with a body mass index (BMI) exceeding 30. 8.Subjects with potential allergies to materials (e.g., plastic) used in the device. 9.Subjects with irregular lifestyles due to shift work or night work. 10.Subjects who are currently participating in another clinical trial, or who have participated in another clinical trial within the past three months. 11.Subjects who are pregnant, breastfeeding, have the potential to become pregnant, or intend to become pregnant during the study period. 12.Subjects who are judged as ineligible to participate in this study by the principal investigator. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 04 Day Date of IRB - 2025 Year 06 Month 18 Day Anticipated trial start date - 2025 Year 09 Month 14 Day Last follow-up date - 2025 Year 10 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067493

Disclaimer: Curated by HT Syndication.