UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062000 |
|---|---|
| Receipt number | R000070946 |
| Scientific Title | A verification study of effects of consumption of the test food on hair growth or hair: an open-label study |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 11:30:59 |
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Basic information
Public title
A verification study of effects of consumption of the test food on hair growth or hair
Acronym
A verification study of effects of consumption of the test food on hair growth or hair
Scientific Title
A verification study of effects of consumption of the test food on hair growth or hair: an open-label study
Scientific Title:Acronym
A verification study of effects of consumption of the test food on hair growth or hair
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on hair growth or hair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured values of the percentage of anagen hairs and the percentage of telogen hairs of hair follicle, the number of hairs, the percentage of vellus hair, the percentage of non-vellus hair, and the density of hair at 12 weeks after consumption (12w)
Key secondary outcomes
1. The measured values of the amount of gray hair, thickness of hair on the head, the amount of hair loss on the head, stickiness of head and scalp, condition of the firmness of the hair, condition of dandruff, volume of hair, satisfaction with hair condition, and concerns and stress related to hair condition at 12w
2. Individuals who experienced adverse events
3. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening
4. Physical measurements, urinalysis, and peripheral blood test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test product: Test food
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
Key exclusion criteria
Individuals (who / whose)
1. are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. have an implanted pacemaker or implantable cardioverter defibrillator
3. are currently undergoing treatment for any of the following chronic diseases:
cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. have a past or current medical history of atopic dermatitis, who have bronchial asthma, conjunctivitis, or atopic dermatitis, or whose family members have any of these diseases
5. may develop allergic rhinitis or who plan to take medication for symptom relief during this study
6. have any symptoms (e.g., diseases such as urticaria, inflammation, eczema, external wound, acne, boil, wart, or traces of them) on the skin at evaluation sites (face or cephalon) that may influence the results of this study
7. have undergone or plan to undergo any special procedures (such as hair transplantation or hair extension) within the last four weeks or during this study
8. shaving of their head will interfere with their daily life
9. cannot collect hair due to short hair such as shaved hair
10. uric acid level is 7.0 mg/dL or more
11. have a medical history of drug or alcohol dependence
12. consume Foods for Specified Health Uses or Foods with Functional Claims
13. are taking or using medications (including herbal medicines) or supplements
14. are allergic to medications and foods related to the test product, particularly those allergic to salmon
15. are pregnant, lactating, or planning pregnancy during this study
16. are deemed unsuitable for participation in this study by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
API Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
API 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070946
