Tokyo, May 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057916) titled 'Verification of effects on autonomic nervous system, by inhalation of test products-including aroma' on May 21.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - KOBAYASHI Pharmaceutical Co.,Ltd.
Condition:
Condition - Healthy female volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to compare the physiological and psychological effects of using fragrances containing synthetic fragrances as air fresheners in women aged 20 to 49 years old, using a placebo fragrance as a control.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Smell the test products-including aromas
Interventions/Control_2 - Smell the control product
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Female
Key inclusion criteria - (1) Women aged 20 to 50 at the time of obtaining informed consent
(2) Those with a BMI of 18.5 or more and less than 25.0 kg/m2
(3) Individuals who have received a sufficient explanation of the study, can understand the contents, and can give their own informed consent
Key exclusion criteria - (1) People who dislike citrus scents such as lemon, herbal scents such as lavender and eucalyptus, and woody scents such as incense and cypress.
(2) People who have a habit of smoking (excluding those who have quit smoking for more than six months)
(3) Those taking foods for specified health uses, foods with functional claims (GABA, lactobacillus drinks for stress relief, etc.), health foods (including supplements), etc. that may affect the study
(4) Persons whose eyes (exotropia, esotropia, ptosis, etc.) or eyelashes are not suitable for pupil measurement
(5) Persons who have dry eyes or other conditions that impede pupil measurement
(6) Persons who are aware of claustrophobia or nyctophobia
(7) Persons who are aware of daily daytime sleepiness or who have irregular sleep hours due to night shifts, etc.
(8) People who are taking medications on an ongoing basis
(9) People who are aware of poor circulation (including people who feel cold hands and feet even in summer)
(10) People who have stuffy noses due to allergic rhinitis, or who cannot distinguish between scents
(11) Persons with external wound at the measurement site
(12) Persons currently participating in clinical trials of other drugs or health foods, or who have completed the trial within 4 weeks
(13) Persons with symptoms of skin diseases such as atopic dermatitis
(14) Persons with a history or current history of serious diseases of the heart, liver, kidneys, digestive system, etc.
(15) Persons who are pregnant, wish to become pregnant, or are breastfeeding
(16) Individuals with chemical sensitivity or allergies to essential oils, alcohol, or synthetic fragrances
(17) Individuals who have experienced or may experience nausea from the smell of alcohol or synthetic fragrances
(18) Individuals who are deemed inappropriate for participation in this study by the principal investigator, etc.
Target Size - 20
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 04 Month 21 Day
Date of IRB - 2025 Year 04 Month 18 Day
Anticipated trial start date - 2025 Year 05 Month 21 Day
Last follow-up date - 2025 Year 05 Month 23 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066181
Disclaimer: Curated by HT Syndication.
