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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029627
Receipt No. R000033845
Scientific Title Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Date of disclosure of the study information 2018/12/31
Last modified on 2017/11/09

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Basic information
Public title Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Acronym Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Scientific Title Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Scientific Title:Acronym Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Region
Japan

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

Objectives
Narrative objectives1 We confirm pharmacokinetics of royal jelly metabolites by measuring a blood level of the metabolites before and 0.25, 0.5, 1, 2, 4, 8, 12 h after intake of protease digested royal jelly.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We confirm pharmacokinetics of royal jelly metabolites by measuring a blood level of the metabolites before and 0.25, 0.5, 1, 2, 4, 8, 12 h after intake of protease digested royal jelly.
Key secondary outcomes We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis. (Measuring before and 12 h after intake of protease digested royal jelly.)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Protease digested royal jelly
Intake:2,400 mg
Ingesion:1day
Interventions/Control_2
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
69 years-old >=
Gender Male and Female
Key inclusion criteria The subjects of the experiment and the Japanese who meet the criteria for all of the following.
1) Healthy japanese
2) Males and females from 20 to 69 years old
3) BMI 18.5-24.9
4) Volunteers who is capable to understand and sign the informed consent
Key exclusion criteria The subjects in conflict with any of the following condition are excluded.
1) A person who has a food allergy
2) A person who has an asthma
3) A women who is pregnant, hope for the pregnancy, or breastfeeding
4) A parson who participated in other clinical trial at resent (past 3 months)
5) A person who has the infectious disease
6) A person 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.
7) A person who with the disease to liver, kidney, heart, diabetes and serious desease
8) A person who has received medical treatment of drug now
9) A person who can not visit the designated examination date (including the previous night) and be hospitalized until the trial end.
11) A person who Those who can not quit smoking from dinner the day before the examination to the examination end
12) A person who cannot take in royal jelly according to instruction or cannot maintain rest until the trial end.
13) A person who can not ban the intake of royal jelly-containing food from one week before the clinical trial.
14) A person who cannot keep regular hours
15) A person who is not daily service (who is night or rotation duty)
16) A person who has taken the blood sampling 200 mL within 4 weeks or 400 mL within 3 months at the time of starting this trial
17) A person who is a heavy alcohol drinker (over 500 mL beer per day )
18) A person who is a heavy smorker (over 20 cigarettes per day)
19) A person who dentified as improper by the principal investigator or subinvestigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Sugimoto
Organization Medical corporation Koganeibasi Sakura Clinic
Division name Not applicable
Zip code
Address 2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
TEL 042-382-5101
Email info@kb-clinic.com

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Yamaga
Organization Yamada Bee Company, Inc.
Division name Institute for Bee Products & Health Science
Zip code
Address 194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL 0868-54-3825
Homepage URL
Email my1636@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 Research Center for Immunological Analysis. Inc.
Name of secondary funder(s) none

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
2018 Year 12 Month 31 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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 19 Day
Last modified on
2017 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033845

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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