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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032482
Receipt No. R000037038
Scientific Title Royal jelly improves endothelial function
Date of disclosure of the study information 2018/06/01
Last modified on 2020/03/18

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Basic information
Public title Royal jelly improves endothelial function
Acronym Royal jelly improves endothelial function
Scientific Title Royal jelly improves endothelial function
Scientific Title:Acronym Royal jelly improves endothelial function
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Medicine in general Cardiology Geriatrics
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study assesses whether royal jelly improves endothelial function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of rective hyperemia peripheral arterial tonometry (RH-PAT) index 4 weeks after administration of royal jelly supplements.
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Administration of royal jelly supplement for 4 weeks.
Interventions/Control_2 Administration of placebo supplement for 4 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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Subjects who did not have hypertension, diabetes, or
dyslipidemia.
2) non-smoker
3) Participates who are confirmed their willingness to participate in this study and be obtained written consent afterexplanation of the study.
Key exclusion criteria Subjects who meet the following criteria are excluded from the subjects of this study.
1) Those who have been pointed out hypertension, diabetes, dyslipidemia by health screening.
2) Current smoker or those with a history of smoking within one year
3) Patients undergoing hypertension, diabetes, and
dyslipidemia
4) Patients undergoing any drug therapies in any medical disorders (kidney diseases, gastrointestinal diseases, heart diseases, lung diseases, neurological diseases, endocrine diseases, collagen diseases, or blood diseases)
5) Patients undergoing periodic medical therapy other than 4)
6) Patients who have severe complications such as malignant tumor or whose life expectancy is severely restricted
7) Patients who may be pregnant or may be pregnant (receive a pregnancy test as necessary)
8) Patients who are allergic to honey
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Tsujita
Organization Kumamoto University
Division name Department of Cardiovascular Medicine, Graduate School of Medical Sciences
Zip code 862-8556
Address 1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL 81-96-373-5175
Email tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Koichiro
Middle name
Last name Fujisue
Organization Kumamoto University Hospital
Division name Cardiovascular medicine
Zip code 862-8556
Address 1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL 81-96-373-5175
Homepage URL
Email fujisues@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Sugi Bee Garden
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 The Human Ethics Review Committee of Kumamoto University
Address 1-1-1, Honjo, Chuo-ku, Kumaoto
Tel 81-96-373-5657
Email byi-senshin@jimu.kumamoto-u.ac.jp

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
2018 Year 06 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 100
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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 06 Day
Date of IRB
2018 Year 08 Month 10 Day
Anticipated trial start date
2018 Year 08 Month 10 Day
Last follow-up date
2020 Year 02 Month 29 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 05 Month 06 Day
Last modified on
2020 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037038

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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