UMIN ID: UMIN000054153
Registered date:15/04/2024
Effect of Aroma of Traditional Chinese Medicine on Fatigue and Work Efficiency: A Randomized, Non-Blinded, Crossover Comparative Study
Basic Information
Recruitment status | Pending |
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Health condition(s) or Problem(s) studied | Healthy Adult |
Date of first enrollment | 2024/04/18 |
Target sample size | 24 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Subjects will remain in a room infused with the aroma of traditional Chinese Medicine for approximately an hour, during which they will undergo a series of examinations. Subjects will remain in a room infused with the aroma of single-herbal medicine for approximately an hour, during which they will undergo a series of examinations. Subjects will remain in a non-interventional (odor-free) room for approximately an hour, during which they will undergo a series of examinations. |
Outcome(s)
Primary Outcome | Blood Pressure, Pulse, Body Temperature, Autonomic Nervous System Function, VAS questionnaire (Body coldness, Fatigue, Sleepiness, Motivation, Concentration, Comfort of room smell), the score of Uchida-Kraepelin Performance Test |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 25years-old |
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Age maximum | 60years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | (1) Subjects currently suffering from severe chronic disease and undergoing treatment and medication under physicians. (2) Subjects who have been diagnosed with abnormal electrocardiogram (such as arrhythmia). (3) Subjects with nasal congestion or those who have difficulty discerning scents. (4) Smokers. (5) Subjects who are sensitive to the smell of traditional Chinese medicine or herbal medicine. (6) Pregnant women, those who may be pregnant, and breastfeeding women. (7) Subjects are currently participating in other clinical trials. |
Related Information
Primary Sponsor | Macromill, Inc. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Heating & Ventilation A/C Company, Panasonic Corporation |
Secondary ID(s) |
Contact
public contact | |
Name | Ayumi Sugioka |
Address | Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan Japan 108-0075 |
Telephone | 03-6716-0700 |
sugioka@macromill.com | |
Affiliation | Macromill, Inc. Clinical Research Unit, Life Science Division |
scientific contact | |
Name | Soma Ode |
Address | Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan Japan |
Telephone | 03-6716-0700 |
ohde@macromill.com | |
Affiliation | Macromill, Inc. Clinical Research Unit, Life Science Division |