UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049039 |
|---|---|
| Receipt number | R000055420 |
| Scientific Title | Several evaluations for those suffering from thinning hair |
| Date of disclosure of the study information | 2024/02/16 |
| Last modified on | 2024/09/30 17:46:44 |
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Basic information
Public title
Several evaluations for those suffering from thinning hair
Acronym
Several evaluations for those suffering from thinning hair
Scientific Title
Several evaluations for those suffering from thinning hair
Scientific Title:Acronym
Several evaluations for those suffering from thinning hair
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the functionality of the test food on hair and scalp in healthy adult subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of Life Questionnaire(0 week, 12week and 24week)
Key secondary outcomes
VAS Questionnaire
Measuring Hair and Scalp Condition
Scalp moisturization
Blood test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of test food once daily for 24 weeks
Interventions/Control_2
Oral intake of control food once daily for 24 weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese men and women between the ages of 40 and 64 at the time of consent
Subjects who notice thinning hair compared to when they were in their 20s
Subjects who can agree to the contents of the examination
Key exclusion criteria
Subjects suffering from alopecia areata
Subjects who are currently undergoing any kind of outpatient treatment or drug treatment
Subjects with underlying medical conditions
Subjects with allergies
Subjects taking medications, health foods, or topical products that may affect the results of the study
Subjects who have had hair transplants or plan to have hair transplants during the study period
Subjects who have difficulty maintaining their lifestyle during the test period
Subjects who have difficulty completing the subject logbook
Subjects who is pregnant or lactating or planning to become pregnant or lactate during the study period
Subjects participating in other clinical trials
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Takuto |
| Middle name | |
| Last name | Yamasaki |
Organization
Hayashikane Sangyo Co., Ltd.
Division name
functional food division
Zip code
750-8608
Address
2-4-8 Yamatomachi, Shimonoseki-Shi, Yamaguchi, JAPAN
TEL
083-267-0094
Homepage URL
tyamasaki@hayashikane.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Hayashikane Sangyo Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
jimukyoku@mail.souken-r.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 16 | 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
56
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
| 2022 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055420
