UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047867 |
|---|---|
| Receipt number | R000054574 |
| Scientific Title | Change confirmation test of hair strength using a royal jelly |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2022/11/25 09:13:32 |
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Basic information
Public title
Change confirmation test of hair strength using a royal jelly
Acronym
Change confirmation test of hair strength using a royal jelly
Scientific Title
Change confirmation test of hair strength using a royal jelly
Scientific Title:Acronym
Change confirmation test of hair strength using a royal jelly
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of Royal jelly for healthy adults for 4 weeks on hair strength.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We confirm effectiveness by measuring hair strength.
(Measuring before and 4week after intake of test food.).
Key secondary outcomes
Hair diameter
Amount of active sulfur in hair
Hair and pore score
Questionnaire
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
test foods containing royal jelly
Intake:300 mg
Ingesion:28day
Interventions/Control_2
placebo
Ingesion:28day
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
Target subjects must satisfy the following selection criteria.
1. Healthy Japanese women aged more than 20 years and lsee than 59 years at the time of giving informed consent.
2. Subjects who understands that clinical visits are mandatory during clinical study period.
3. Subjects who has freely given consent and has understood the purpose of the study.
Key exclusion criteria
The subjects in conflict with any of the following condition are excluded.
1. Subjects who have current or history of food allergies or asthma.
2. Subjects who had participated in other clinical trials such as application tests of other hair growth agents / cosmetics and drinking tests of beauty foods within the last 4 weeks prior to the current study.
3. Subjects who cannot stop taking RJ-containing foods during the test period
4. Subjects who have trauma or inflammation on the scalp.
5. Subjects with atopic dermatitis and chronic skin diseases.
6. Subjects who are using hair growth agents and hair growth agents.
7. Subjects in pregnancy or in nursing.
8. Subjects who have received "hormone replacement therapy" or taken oral contraceptives within 1 year
9. Subjects with an average hair diameter of 0.06 mm or less
10. Subjects who plan to perform care other than hair care in daily life and hair dyeing / bleaching during the test period.
11. Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ayanori |
| Middle name | |
| Last name | Yamaki |
Organization
Yamada Bee Company, Inc.
Division name
Functional lngredient research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
ay1255@yamada-bee.com
Public contact
Name of contact person
| 1st name | Hayate |
| Middle name | |
| Last name | Itatani |
Organization
Yamada Bee Company, Inc.
Division name
Functional lngredient research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
Homepage URL
hi1727@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pharmacokinetics and Biopharmaceutics, Institute of Health Bioscience, Tokushima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
Tel
0868-54-1199
hi1727@yamada-bee.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
| 2022 | Year | 06 | Month | 03 | 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
20
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 | 02 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 06 | 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 | 05 | Month | 26 | Day |
Last modified on
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054574
