UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032818
Receipt number 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 16:54:40

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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 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

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

Value
https://center6.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