Tokyo, March 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061029) titled 'Effects of Palm G-poin Stimulation Using a Novel Stimulation Device on Microcirculatory Blood Flow' on March 24.
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 evaluate, using a crossover design, the effects of the G-point on the palm stimulation with a novel stimulation device on microcirculatory blood flow.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - G-point stimulation - Washout - Sham stimulation
Interventions/Control_2 - Sham stimulation - Washout - G-point 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 90 years at the time of written informed consent.
2. Participants 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.
3. Participants who can come to the facility on the designated test date and take the test.
4. Participants who are healthy enough to exercise.
Key exclusion criteria - 1.Participants with chronic diseases associated with exercise restrictions, or those currently receiving treatment for any diseases.
2.Participants 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.Participants with a history or current diagnosis of low back pain or spinal disorders (e.g., herniated disc, spinal canal stenosis).
4.Participants with a history or current diagnosis of severe cardiovascular, respiratory, hepatic, renal, hematologic, or gastrointestinal disorders that may adversely affect health during exercise.
5.Participants with severe anemia.
6.Participants who have continuously used medications (oral or topical) for disease treatment within the past month.
7.Participants with a body mass index (BMI) exceeding 30.
8.Participants with potential allergies to materials (e.g., plastic) used in the device.
9.Participants with irregular lifestyles due to shift work or night work.
10.Participants who are currently participating in another clinical trial, or who have participated in another clinical trial within the past three months.
11.Participants who are pregnant, breastfeeding, have the potential to become pregnant, or intend to become pregnant during the study period.
12.Participants who are judged as ineligible to participate in this study by the principal investigator.
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 23 Day
Date of IRB - 2025 Year 11 Month 19 Day
Anticipated trial start date - 2026 Year 03 Month 26 Day
Last follow-up date - 2026 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069841
Disclaimer: Curated by HT Syndication.