UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022621
Receipt No. R000026075
Scientific Title Raman spectrometer for human healthy skin (Intake of royal jelly)
Date of disclosure of the study information 2016/07/01
Last modified on 2018/08/13

* 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 Raman spectrometer for human healthy skin
(Intake of royal jelly)
Acronym Raman spectrometer for human healthy skin
(Intake of royal jelly)
Scientific Title Raman spectrometer for human healthy skin
(Intake of royal jelly)
Scientific Title:Acronym Raman spectrometer for human healthy skin
(Intake of royal jelly)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the moisture effect under the intake of royal jelly
Basic objectives2 Others
Basic objectives -Others To evaluate the moisture effect under the intake of royal jelly
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes TEWL, disutribution of natural moisturaizing factor, amino acids, and lipid in the skin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Administration of the 1000mg royal jelly for 16 weeks
Interventions/Control_2 Administration of pracebo for 16 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
20 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria Healthy female
Key exclusion criteria Administration of steroid and immunosuppressant
Pregnancy
Food allergy, bee allergy and asthma
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atushi Otsuka
Organization Kyoto University
Division name Division of Dermatology
Zip code
Address 54 Kawahara-cho Shogoin Sakyo-ku Kyoto-shi 606-8507 Japan
TEL 075-751-3605
Email otsukamn@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chisa Nakashima
Organization Kyoto University
Division name Division of Dermatology
Zip code
Address 54 Kawahara-cho Shogoin Sakyo-ku Kyoto-shi 606-8507 Japan
TEL 075-751-3605
Homepage URL
Email chisa313@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Kyoto University
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
Address
Tel
Email

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
2016 Year 07 Month 01 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
SC conductance was significantly higher in a RJ group than a control group at day 84. 
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
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2017 Year 05 Month 17 Day
Date of closure to data entry
2017 Year 05 Month 17 Day
Date trial data considered complete
2018 Year 03 Month 12 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 06 Day
Last modified on
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026075

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.