UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054153 |
|---|---|
| Receipt number | R000061795 |
| Scientific Title | Effect of Aroma of Traditional Chinese Medicine on Fatigue and Work Efficiency: A Randomized, Non-Blinded, Crossover Comparative Study |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/04/15 12:22:26 |
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Basic information
Public title
Effect of Aroma of Traditional Chinese Medicine on Fatigue and Work Efficiency: A Randomized, Non-Blinded, Crossover Comparative Study
Acronym
Effect of Aroma of Traditional Chinese Medicine on Fatigue and Work Efficiency
Scientific Title
Effect of Aroma of Traditional Chinese Medicine on Fatigue and Work Efficiency: A Randomized, Non-Blinded, Crossover Comparative Study
Scientific Title:Acronym
Effect of Aroma of Traditional Chinese Medicine on Fatigue and Work Efficiency
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the aroma of traditional Chinese medicine on improving fatigue and work efficiency, and its impact on perceived body temperature and autonomic nervous system function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
Subjects will remain in a non-interventional (odor-free) room for approximately an hour, during which they will undergo a series of examinations.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who are office workers and primarily engage in desk work.
(2) Subjects who have received explanation about the purpose and content of this study, possess the capacity to consent, understand the content well, and can provide consent electronically through informed consent.
Key exclusion 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.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Research Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Sugioka |
Organization
Macromill, Inc.
Division name
Clinical Research Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
Homepage URL
sugioka@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Heating & Ventilation A/C Company, Panasonic Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Tsukiji Futaba Clinic.
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo, Japan, 104-0045
Tel
03-6226-5812
tohru@hikobae.net
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
コンフォメディケア小規模多機能ホーム（東京都）
医療法人社団曙光会コンフォガーデンクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061795
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
