Healthy subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals aged 18 years or older at the time of consent, regardless of gender 2. Individuals who have provided written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1.Individuals with cognitive impairment, consciousness disorders, or other conditions that make self-determination difficult 2.Pregnant women or women who may be pregnant 3.Individuals with serious underlying medical conditions such as cardiovascular or respiratory diseases 4.Individuals with internal medical conditions such as hypertension or diabetes that cannot be adequately controlled with medication 5.Any other individuals deemed inappropriate for participation in the study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study will estimate the changes from baseline, as well as the mean values and standard deviations for each of the following parameters during the use of the Golden Value e-Ion product and a control (blank) product. Statistical comparisons will be made to assess differences between the two conditions: I. Peripheral tissue blood flow II. Cardiac output | — |
Secondary
| Measure | Time frame |
|---|---|
| This study will estimate the changes from baseline and compare the mean values and standard deviations for the following parameters under two conditions: use of the Golden Value e-Ion product and use of a control (blank) product. Statistical analysis will be conducted to examine differences between the two products: I. Autonomic nervous function, as assessed by heart rate variability (HRV) analysis II. Core body temperature III. Blood pressure and heart rate IV. Scores from the State-Trait Anxiety Inventory (STAI) Form Y-1 and a Visual Analog Scale (VAS) questionnaire | — |
Countries
Japan
Contacts
Saitama Medical University Research Administration Center