UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046542 |
|---|---|
| Receipt number | R000053102 |
| Scientific Title | A study for the effect of intervention of aroma components on mood state (No.2103-014)- a placebo controlled, randomized, single-blind, parallel-group trial - |
| Date of disclosure of the study information | 2023/09/30 |
| Last modified on | 2022/10/25 14:12:50 |
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Basic information
Public title
A study for the effect of intervention of aroma components on mood state (No.2103-014)- a placebo controlled, randomized, single-blind, parallel-group trial -
Acronym
A study for the effect of intervention of aroma components on mood state (No.2103-014)
Scientific Title
A study for the effect of intervention of aroma components on mood state (No.2103-014)- a placebo controlled, randomized, single-blind, parallel-group trial -
Scientific Title:Acronym
A study for the effect of intervention of aroma components on mood state (No.2103-014)
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of inhaling aromas on mood state.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of Mood States 1
Key secondary outcomes
Profile of Mood States 2
Sleep Quality Index
Autonomic Nerve System Test
Uchida-Kraepelin Test
Olfactory Function Test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Inhalation of the test aroma twice a day for 15 days
Interventions/Control_2
Inhalation of control aroma twice a day for 15 days
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy males and females equal to or more than 20 years and less than 65 years of age
2)Subjects who use Japanese as his/her primary language
3)Subjects who are working
4)Subjects who are aware of mental fatigue on a daily basis
5)Subjects who can use electronic diary application
6)Subjects who have received their second dose of COVID-19 vaccination and have a certificate of vaccination at the time of registration
Key exclusion criteria
1)Subjects who have, have a history, are suspected of having, and/or have a daily medication for the following items: sinusitis, allergic rhinitis (hay fever, etc.), psychiatric disorders (depression, anxiety disorders, etc.), sleep apnea syndrome, restless legs syndrome, insomnia, etc., sleep-related illness, chronic fatigue syndrome, arrhythmia, heart disease, menopausal disorders, history of serious illness (malignancy, diabetes, liver disease (hepatitis), renal disease, cardiac disease, etc.)
2)Subjects who have a difficulty to perform the tests due to a decline in olfactory function, sight, or hearing
3)Subjects with a cardiac pacemaker
4)Subjects who are receiving hormone therapy
5)Those who are judged to be unsuitable as subjects based on the results of the subject background investigation or preliminary examinations
6)Subjects who may have allergies or skin irritation caused by test fragrances or alcohol
7)Subjects who are, or are planning to be pregnant or breastfeeding during test periods
8)Subjects who have irregular lifestyles due to night work, etc.
9)Subjects who plan to travel abroad or go on overseas business trips
10)Subjects who consistently drink more than the appropriate amount of alcohol
11)Smoker, or has smoked within 12 months prior to preliminary examinations
12)Subjects who continuously consume medicines, health foods, food for specified health uses, food with nutrient function claims, or food with functional claims containing ingredients that may affect mood, fatigue, stress, sleep, or the autonomic nervous system at least once a week
13)Subjects who continuously use fragrances such as perfume, aroma diffuser, aroma spray, aroma bath, incense, etc. at least once a week
14)Subjects who have participated in other clinical trials within one month prior to the preliminary examinations or plan to participate during the study period
15)Subjects who are ineligible due to principal investigator's judgement
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kuniaki |
| Middle name | |
| Last name | Obara |
Organization
Kirin Holdings Company, Limited
Division name
Kirin Central Research Institute, Research & Development Division
Zip code
251-8555
Address
Shonan Health Innovation Park , 26-1 Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan
TEL
080-1930-9932
k-obara@kirin.co.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
105-0004
Address
Shinbashi 2-16-1 Minato-ku, Tokyo, Japan
TEL
080-7290-0404
Homepage URL
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.com
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
茅場町こころのケアクリニック（東京都）
Kayaba-cho Mental Health Care Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 10 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 05 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053102
