UMIN-CTR Clinical Trial

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
Email	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
Email	hi1727@yamada-bee.com

Sponsor
Institute	Yamada Bee Company, Inc.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054574