UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039676 |
|---|---|
| Receipt number | R000045242 |
| Scientific Title | Verification of the effect of aroma on exercise characteristics-Group comparison study- |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2020/09/02 11:47:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of the effect of aroma on exercise characteristics-Group comparison study-
Acronym
Verification of the effect of aroma on exercise characteristics
Scientific Title
Verification of the effect of aroma on exercise characteristics-Group comparison study-
Scientific Title:Acronym
Verification of the effect of aroma on exercise characteristics
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of changes in exercise characteristics by aroma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise test
(Odorless control,Aroma A,Aroma B)
Key secondary outcomes
Psychological examination
(Odorless control,Aroma A,Aroma B)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Aroma A:Sticker
Once
Interventions/Control_2
Aroma B:Sticker
Once
Interventions/Control_3
Odorless target:Sticker
Once
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male and female aged 30 to 59 years old at the time of the informed consent
2.No smoking (past smoking experience is acceptable)
3.No aroma use
4.Healthy (No problem in the preliminary inspection)
5.No history of hospitalization / visit within 1 year
6.Have received the health checkup for 2019 and have no problem(Minor abnormalities and follow-up observations are within the standard)
7.BMI value between 18.5 and 30
8.No abnormalities in wrist or back condition (injuries, numbness, paralysis, etc.)
9.No problem with physical condition (electrocardiogram, blood pressure, pulse, body temperature) on the day of the test, and the doctor's interview, and who is considered to be inappropriate to attend the present study by the investigator
10.Applicants who receive a sufficient explanation of the purpose and content of this study, have the ability to consent, have a good understanding, volunteer to participate, and agreed to participate in this study
11.Subjects who can come on the designated inspection day and can be inspected
Key exclusion criteria
1.Subjects who check in the range of 25% from very dislike in the VAS type questionnaire with scent taste (very dislike-very like)
2.Subjects under 30 and over 60
3.Subjects who is currently going to the hospital and are under treatment
4.Subjects with mental disorders
5.Subjects under medication
6.Subjects who are pregnant or possibly pregnant, or lactating
7.Abnormality found in ECG check
8.Subjects who has high blood pressure / low blood pressure (except systolic blood pressure 90-135mmHg)
9.Subjects who has tachycardia (pulse rate over 90 beats / min)
10.Subjects with respiratory, circulatory, otolaryngological diseases (including chronic sinusitis), or orthopedic diseases
11.Subjects who cannot smell the aroma
12.Subjects with smoking habits
13.Subjects who drink a large amount of alcohol every day (1500ml / day for beer, 3go / day for sake, 2go / day for shochu)
14.Subjects who may show allergic symptoms by the test product (or person who have allergic symptoms)
15.Subjects who prefer unscented and subjects who do not like aroma (have aversion to menthol (e.g., scents such as VICKS vaporub)
16.Subjects who use aroma in daily life * Aroma is the use of a diffuser, aroma lamp, etc. take an aromatic bath such as essential oils.
17.Subjects with physical pain which causes problems in daily life
18.Those who cannot walk for more than 10 minutes without resting in everyday walking
19.Subjects who have difficulty going up and down the stairs
20.Subjects who cannot ride a bicycle for more than 20 minutes
21.Subjects who are left-handed
22.Subjects who are participating in other clinical studies
23.Subjects who have problem with the physical condition measurement on the day of the testing or a doctor's interview, and are judged by the investigator to be inappropriate for this study
24.Subjects who are considered to be inappropriate to attend the present study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Abe |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totuska-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3891
Ay0272@fancl.co.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Imasu |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totuska-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3868
Homepage URL
toimasu@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
jimukyoku@tes-h.co.jp
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
うえのあさがおクリニック
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 04 | 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
24
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
| 2020 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 13 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 19 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 03 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045242
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
