UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051529 |
|---|---|
| Receipt number | R000058782 |
| Scientific Title | Effects of consumption of the test food on hair growth or hair: an open-label, non-randomized, pre-post comparison trial |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/10 15:48:19 |
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Basic information
Public title
Effects of consumption of the test food on hair growth or hair
Acronym
Effects of consumption of the test food on hair growth or hair
Scientific Title
Effects of consumption of the test food on hair growth or hair: an open-label, non-randomized, pre-post comparison trial
Scientific Title:Acronym
Effects of consumption of the test food on hair growth or hair
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
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
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The number of hairs and the percentage of gray hair at four, 12, and 20 weeks after consumption (4w, 12w, and 20w)
Key secondary outcomes
1. The percentage of vellus hair, the percentage of non-vellus hair, the percentage of anagen hair, the density of hair, the number of fallen hair, an original questionnaire using visual analogue scale (VAS) (the amount of gray hair, thinness 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) at 4w, 12w, and 20w
2. The scalp condition at 4w, 12w, and 20w.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 20 weeks
Test food: Hair growth supplement
Administration: Take three capsules with water once daily.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: 20 weeks
Test food: Anti-gray hair supplement
Administration: Take three capsules with water once daily.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_3
Non intake
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 subjects
5. Subjects who voluntarily consent to participate in this trial
6. Subjects who have been suffering from thinning hair or gray hair for the past two years
Key exclusion criteria
Subjects (who/whose)
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, 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 trial
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 trial
8. shaving of their head will interfere with their daily life
9. cannot collect hair due to short hair such as shaved hair
10. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
11. are currently taking medications (including herbal medicines) and supplements
12. are allergic to medicines and/or the test food related products
13. have a medical history of drug or alcohol dependence
14. are pregnant, lactating, or planning to become pregnant during this trial
15. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
16. are judged as ineligible to participate in this study by the physician
Target sample size
60
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
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Milbon Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
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
| 2024 | Year | 06 | Month | 01 | 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
72
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
| 2023 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058782
