Healthy adults
Conditions
Interventions
Participants will wear a finger temperature measurement device and alternate every 40 minutes between rooms maintained at 25 and 15 degrees Celsius. Finger temperature will be measured throughout. A t
Sponsors
KOBAYASHI Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese males and females aged between 20 and 50 years at the time of obtaining informed consent (2) Individuals with a BMI between 18.5 and 30 (3) Individuals who have sufficient decision-making capacity, received a full explanation of the study objectives and procedures, fully understood the contents, voluntarily agreed to participate, and provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Individuals currently undergoing pharmacological treatment for any disease 2. Individuals with a history of, or currently being treated for, serious diseases such as diabetes, kidney disease, liver disease, heart disease, thyroid disorders, adrenal disorders, or other metabolic diseases 3. Individuals with a history of, or currently diagnosed with, autoimmune diseases such as collagen disease or rheumatoid arthritis 4. Individuals with chronic diseases who are regularly taking medications 5. Individuals with known allergies to metals or resins 6. Individuals with implanted metallic medical devices such as pacemakers 7. Individuals with visible inflammation, trauma, or dermatological conditions (e.g., erythema, erosion, contact dermatitis) on the skin of the left hand (dorsum and palm) 8. Individuals with visible deformity, edema, or limited range of motion in the left ring finger 9. Individuals who have donated more than 200 mL of blood in the past month or more than 400 mL within the past three months 10. Individuals who are aware of having anemia in daily life 11. Individuals who are aware of cold sensitivity (poor peripheral circulation) in the hands or feet 12. Individuals with a history or current condition of drug or alcohol dependence 13. Individuals who experience any symptoms (e.g., headaches, rhinitis, urticaria) in response to temperature changes such as cold-induced urticaria or temperature-sensitive allergies 14. Pregnant or lactating women, or those who may be pregnant 15. Individuals who are unable to remove rings or other accessories from their hands on the day of the study 16. Individuals currently participating in another clinical trial, or who have participated in another clinical trial within the past 3 months 17. Any other individuals deemed unsuitable for participation in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation, agreement, and temporal trends between finger temperature measured by thermography and that measured by the finger temperature monitoring device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Correlation, agreement, and temporal trends between finger temperature measured by thermography and that measured by the finger temperature monitoring device, analyzed by individual, sex, and ambient room temperature. 2. Safety and tolerability (based on questionnaire responses). | — |
Countries
Japan
Contacts
Public ContactShota Kajiyama
KOBAYASHI Pharmaceutical Co., Ltd. Life Science Research Department R&D Headquarters
Outcome results
None listed