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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034539
Receipt No. R000039376
Scientific Title Effects of enzyme-treated royal jelly for Skin Conditions for healthy individuals.
Date of disclosure of the study information 2019/06/30
Last modified on 2021/03/11

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Basic information
Public title Effects of enzyme-treated royal jelly for Skin Conditions for healthy individuals.
Acronym Effects of enzyme-treated royal jelly for Skin Conditions for healthy individuals.
Scientific Title Effects of enzyme-treated royal jelly for Skin Conditions for healthy individuals.
Scientific Title:Acronym Effects of enzyme-treated royal jelly for Skin Conditions for healthy individuals.
Region
Japan

Condition
Condition Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of enzyme-treated royal jelly for Skin Conditions of healthy individuals.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes skin moisture content
Key secondary outcomes -Indexes for skin conditions
(transepidermal water loss, skin viscoelasticity, visual evaluation, etc.).
-Changes in Physical examinations from the baseline evaluation (visit0)
(interview, auscultation, percussion, inspection, palpation, etc.)
-Clinical laboratory values.

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 enzyme-treated royal jelly
Intake: 1,344 mg
Ingestion: 84 day
Interventions/Control_2 Placebo
Intake: 1,344 mg
Ingestion: 84 day
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
80 years-old >
Gender Male and Female
Key inclusion criteria Target Healthy Japanese male and female subjects must satisfy the following selection criteria.
- Aged betmeen 20 and 79 years.
-With skin dryness.
- Can understand and comply with the rules written in protocol during clinical study period.
- With writteninformed consent spontaneously.
- Judged appropriate for participation in this study by the doctor.
Key exclusion criteria The following exclusion criteria apply to subjects.
- Intake royal jelly or enzyme-treated royal jelly-containing food daily.
- Have a food allergy or bee sting allergy or asthma.
- Visit dermatology department(for the purpose of treating atopic dermatitis etc.).
- With strange skin conditions at measurement points.
- Intake medicines or health foods that may affect results.
- Have a disorder to absorption, distribution, metabolism, excretion of food, such as digestive tract, liver, kidney, heart and cardiovascular system.
- With a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on.
- Undergoing medication treatment or going to receive medication.
- Conducting hormone replacement therapy.
- Have received a cosmetic medicine/
- Will get sunburned during the test period.
- Can not continue regular life
- Have an irregular habit because of working at night or working under work-shift form.
- Have taken the blood sampling either 200 mL within 4 weeks or 400 ml within 3 months at the time of starting this clinical study.
- Drinks more than 500 ml beer daily
- A smoker.
- Nursing or pregnant woman.
- Participated in other clinical trial including patch test of cosmetics within last 3 months.
- Working at the health food, cosmetics or pharmaceutical company.
- Judged not appropriate by principal investigator.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Kayoko
Middle name
Last name Numano
Organization Queen's Square Medical Facilities
Division name Not applicable
Zip code 220-6208
Address 2-3-5,Minatomirai,Nishi-ku,Yokohama-shi,Kanagawa, 220-6208, Japan
TEL 045-682-4112
Email sakurai@inforward.co.jp

Public contact
Name of contact person
1st name Nobuaki
Middle name
Last name Okumura
Organization Yamada Bee Company, Inc.
Division name 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 no1780@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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Aesthetic Dermatology Symposium Ethics Committee
Address 15-1-604,Himonya 5-Chome,Meguro-ku,Tokyo,Japan
Tel 03-3794-1235
Email info@jp-ads.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
2019 Year 06 Month 30 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 Completed
Date of protocol fixation
2018 Year 11 Month 05 Day
Date of IRB
2018 Year 11 Month 08 Day
Anticipated trial start date
2018 Year 11 Month 09 Day
Last follow-up date
2019 Year 04 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 17 Day
Last modified on
2021 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039376

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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