UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059397 |
|---|---|
| Receipt number | R000067929 |
| Scientific Title | Observational Study on Physical and Mental Discomfort |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2025/10/14 17:11:01 |
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Basic information
Public title
Observational Study on Physical and Mental Discomfort
Acronym
Observational Study on Physical and Mental Discomfort
Scientific Title
Observational Study on Physical and Mental Discomfort
Scientific Title:Acronym
Observational Study on Physical and Mental Discomfort
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Screening for inflammatory risk factors (SCR) will be conducted to assess smoking status, stress levels, dietary habits, and alcohol consumption. Based on fatigue and insomnia status, subjects will be classified into four groups (A, B1, B2, and C). Biological data, including inflammatory markers and facial image data, will be collected from each group to obtain data for identifying subjects with chronic inflammatory conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Biochemical and hematological tests, high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), derivatives of reactive oxygen metabolites (d-ROMs), biological antioxidant potential (BAP), HbA1c, matrix metalloproteinases (MMP-1, MMP-3, MMP-9), dehydroepiandrosterone sulfate (DHEA-S), estradiol (E2; females only), total testosterone (males only), and free testosterone (males only).
Key secondary outcomes
(2) Urinalysis: 8-hydroxy-2'-deoxyguanosine (8-OHdG).
(3) Chalder Fatigue Questionnaire (CFQ-11).
(4) Athens Insomnia Scale (AIS).
(5) Perceived Stress Scale (PSS-10).
(6) Kessler Psychological Distress Scale (K6).
(7) Short Form-12 Health Survey (SF-12).
(8) Somatic Symptom Scale-8 (SSS-8).
(9) Lifestyle and medical history: smoking, alcohol consumption, exercise, sleep, breakfast habits, processed food intake, vegetable intake, eating out, past medical history, and medication use.
(10) Facial condition questionnaire.
(11) Facial image and video recording.
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
| 40 | years-old | <= |
Age-upper limit
| 56 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged 40 years or older and under 56 years at the time of obtaining informed consent.
(2) Individuals who have sufficient decision-making capacity, have received a full explanation of the purpose and content of this study, fully understand the information provided, and voluntarily agree to participate by providing their own written informed consent.
Key exclusion criteria
(1) Individuals who regularly use drugs affecting the evaluation (e.g., steroids, anti-allergic agents, immunosuppressants, antihistamines).
(2) Individuals with severe allergic diseases such as pollinosis.
(3) Individuals under dermatological treatment for facial skin.
(4) Individuals who routinely use therapeutic topical agents on the face.
(5) Individuals with skin conditions such as atopic dermatitis.
(6) Individuals using a cardiac pacemaker.
(7) Individuals with or with a history of serious cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic diseases.
(8) Individuals with chronic diseases (e.g., diabetes, hyperlipidemia, hypertension) under medical treatment.
(9) Individuals who received cosmetic procedures such as laser treatment, peeling, or long-lasting facial hair removal within the past year.
(10) Individuals currently visiting a clinic for aesthetic treatment or skin problems.
(11) Individuals expected to have excessive sun exposure to the face (e.g., sea or pool) from October 22 to December 18, 2025.
(12) Individuals who received or plan to receive tanning, cosmetic, or aesthetic treatments on the face during the same period.
(13) Individuals who experienced discomfort or health problems from blood sampling.
(14) Individuals suspected of infection with hepatitis B, hepatitis C, syphilis, or HIV.
(15) Women who are pregnant, possibly pregnant, breastfeeding, or intending pregnancy during the study.
(16) Individuals unable to maintain their usual lifestyle due to travel, relocation, exams, or other major events during the study period.
(17) Individuals currently in another study, within four weeks of prior study participation, or planning to join another study.
(18) Individuals judged ineligible by the principal investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Department , 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 | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Clinical Trial Department , 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
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO HEALTHCARE CO., LTD.
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
Institutional review board of Tsukiji Futaba Clinic
Address
1-9-9, Tsukiji, Chuou-ku, Tokyo, Japan
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | 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
| 2025 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2025 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067929
