UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034539 |
|---|---|
| Receipt number | 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 09:31:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
no1780@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
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
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
Value
https://center6.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 |
