UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055915 |
|---|---|
| Receipt number | R000063888 |
| Scientific Title | Observational studies to elucidate fatigue factors and mechanisms |
| Date of disclosure of the study information | 2024/11/09 |
| Last modified on | 2024/10/22 12:18:48 |
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Basic information
Public title
Observational studies to elucidate fatigue factors and mechanisms
Acronym
Fatigue Observational Study
Scientific Title
Observational studies to elucidate fatigue factors and mechanisms
Scientific Title:Acronym
Observational studies to elucidate fatigue factors and mechanisms
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the subjective and objective indicators that may be related to fatigue in adult male and female subjects and to determine the causes and mechanisms of fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of the relationship between fatigue status and physical/mental measurement items
Key secondary outcomes
Analysis of the relationship between fatigue and autonomic nervous system activity, blood factors, and sebaceous RNA expression factors
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women between the ages of 30 and 59
Key exclusion criteria
1. Participants who suffer from chronic diseases other than allergic conditions such as allergic rhinitis (e.g., diabetes, hypertension, dyslipidemia, gout, renal diseases, rheumatoid arthritis, respiratory diseases) and are currently taking medication.
2. Participants deemed unable to participate in the trial by a physician due to liver, kidney, heart diseases, respiratory disorders, endocrine disorders, metabolic disorders, consciousness disorders, diabetes, or other diseases.
3. Participants diagnosed with chronic fatigue syndrome by a physician.
4. Participants currently suffering from mental disorders.
5. Participants suffering from sleep disorders such as insomnia or sleep apnea syndrome.
6. Participants who consume alcohol excessively [equivalent to 60g of alcohol/day or more].
7. Participants who have donated 200mL or more of blood within one month or 400mL or more within three months prior to the start of this trial.
8. Participants using implanted medical devices such as pacemakers or implantable cardioverter defibrillators.
9. Participants suffering from skin diseases on the face (e.g., atopic dermatitis, acne vulgaris, psoriasis).
10. Participants using topical medications on the face.
11. Participants who work night shifts or rotational shifts and are not on a day shift schedule.
12. Participants currently participating in other clinical trials or planning to participate in other trials during the period of this trial.
13. Participants who are currently pregnant or intend to become pregnant during the trial period.
14. Participants deemed inappropriate for participation in this trial by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
Organization
Kao Corporation
Division name
Human Healthcare Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8348
hibi.masanobu@kao.com
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
Organization
Kao Corporation
Division name
Human Healthcare Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8348
Homepage URL
hibi.masanobu@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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
株式会社クロス・マーケティング 初台リサーチセンター（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 09 | 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 | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of the relationship between fatigue status and physical/mental measurement items
Management information
Registered date
| 2024 | Year | 10 | Month | 22 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063888
