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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032818
Receipt No. R000037417
Scientific Title Brazilian Green Propolis pharmacokinetics study in healthy volunteers
Date of disclosure of the study information 2018/09/30
Last modified on 2018/12/19

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Basic information
Public title Brazilian Green Propolis pharmacokinetics study in healthy volunteers
Acronym Brazilian Green Propolis pharmacokinetics study in healthy volunteers
Scientific Title Brazilian Green Propolis pharmacokinetics study in healthy volunteers
Scientific Title:Acronym Brazilian Green Propolis 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 Propolis metabolites after intake of Propolis.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We confirm pharmacokinetics of Propolis metabolites by measuring a blood level of the metabolites before and 0.5,1,1.5,2,4,8,12,24 h after intake of Propolis.
Key secondary outcomes We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis (Measuring before and 24 h after intake of Propolis.).

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Brazilian Green Propolis containing food(1)
Intake: 1,275mg
Ingesion:once
Interventions/Control_2 Brazilian Green Propolis containing food(2)
Intake:1,425mg
Ingesion:once
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
45 years-old >=
Gender Male and Female
Key inclusion criteria The subjects who meet all of the following criteria are included in this study.
1) Healthy Japanese
2) Males and females from 20 to 45 years old (at the time of consent acquisition)
3) BMI 18.5-25.0
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 previous history of allergy
2) A person who has a previous history of asthma
3) A woman who is pregnant, hope for the pregnancy, or breastfeeding
4) A person who participated in other clinical trial within 12 weeks prior to ingestion of experimental diet
5) A person who has a positive reaction on the trial for infectious disease at screening
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. (not included appendectomy)
7) A person who has a disease of liver, kidney and heart, diabetes and serious desease
8) A person who has received medical treatment of drug
9) A person who can not visit the designated inspection date (including the previous night) and be hospitalized until the end of a trial.
10) A person who can not quit eating and drinking excluding the designated food the day before the trial to the end of a trial.
11) A person who can not quit smoking from dinner the day before the trial to the end of a trial.
12) A person who cannot take in experimental diet according to instruction or cannot maintain rest until the end of a trial.
13) A person who can not ban the intake of propolis containing food within one week prior to the clinical trial.
14) A person who cannot keep regular hours
15) A person who is not daily service (who is night duty or rotating shift)
16) A person who has taken a blood sample (such as blood donation) of more than 200 mL within 4 weeks or more than 400 mL within 3 months prior to the start of this trial
17) A person who is a heavy alcohol drinker (over 500 mL per day in beer)
18) A person who is a heavy smorker (over 20 cigarettes per day)
19) A person who are judged inappropriate as the subject by the principal investigator or subinvestigators.
Target sample size 10

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 Hidenori Matsuzaki
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 hm1380@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)

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 09 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 05 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 13 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
2018 Year 05 Month 31 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037417

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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