Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058474) titled 'A verification study on the psychological and physiological effects of aroma inhalation' on July 15.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify psychological and physiological effects of the test aroma
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Inhale the aroma of the test product for 2 minutes under spontaneous respiration at the designated time.
Interventions/Control_2 - Inhale the aroma of the placebo product for 2 minutes under spontaneous respiration at the designated time.
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - 1. Female aged 20 to below 50 years at the time of consent acquisition.
2. Individuals with a body mass index (BMI) of 18.5 kg/m2 or higher and less than 25.0 kg/m2.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria - 1. Individuals who dislike citrus or woody scents.
2. Individuals with a smoking habit (except those who have abstained from smoking for more than six months).
3. Individuals who are currently taking pharmaceuticals, Foods for Specified Health Uses, Foods with Function Claims (e.g., GABA), or health foods (including supplements) that may affect the study outcomes.
4. Individuals with eye conditions (e.g., exotropia, esotropia, ptosis) or eyelash shapes that are unsuitable for pupillary measurement.
5. Individuals with conditions that interfere with pupillary measurement, such as dry eye.
6. Individuals with self-reported claustrophobia or nyctophobia.
7. Individuals who experience frequent daytime sleepiness or have irregular sleep patterns, such as night shift workers.
8. Individuals who are continuously taking therapeutic medications.
9. Individuals who are sensitive to cold (including those who feel cold in their extremities even during summer).
10. Individuals with nasal congestion due to allergic rhinitis or those who are unable to distinguish scents.
11. Individuals with injuries at the measurement site.
12. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
13. Individuals with dermatological conditions such as atopic dermatitis.
14. Individuals with chemical sensitivity or allergies to essential oils, alcohol, or synthetic fragrances.
15. Individuals with previous or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
16. Individuals who are pregnant, breastfeeding, or intending to become pregnant during trial period.
17. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target Size - 24
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 06 Month 30 Day
Date of IRB - 2025 Year 06 Month 27 Day
Anticipated trial start date - 2025 Year 07 Month 16 Day
Last follow-up date - 2025 Year 08 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066544
Disclaimer: Curated by HT Syndication.
