UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032817
Receipt number R000037418
Scientific Title Safety verification test using a overdose of the test food "Brazilian green propolis" that intended for healthy individuals
Date of disclosure of the study information 2018/09/30
Last modified on 2018/12/19 16:55:10

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Basic information

Public title

Safety verification test using a overdose of the test food "Brazilian green propolis" that intended for healthy individuals

Acronym

Safety verification test using a overdose of the test food "Brazilian green propolis" that intended for healthy individuals

Scientific Title

Safety verification test using a overdose of the test food "Brazilian green propolis" that intended for healthy individuals

Scientific Title:Acronym

Safety verification test using a overdose of the test food "Brazilian green propolis" that intended for healthy individuals

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will check about safety while people take usual "Brazilian green propolis" excessively for 4 weeks. We evaluated safety through physical examinations (interviews, auscultation, percussion, inspection, palpation, etc.) and changes in clinical laboratory values from the baseline evaluation (vist0, week0) to the second evaluation (visit2, week 4).

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis (Measuring before and 2, 4week after intake of "Brazilian green propolis".).

Key secondary outcomes



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

Brazilian green propolis containing food
Intake:6,375 mg
Ingesion:28day

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

45 years-old >=

Gender

Male and Female

Key inclusion criteria

Target subjects must satisfy the following selection criteria.
1. Healthy Japanese men and women aged more than 20 years, less than 45 years at the time of giving informed consent.
2. A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy.
3. A person who has freely given consent and has understood the purpose of the study.
4. BMI:18.5 - 30.0
5. Excessive exercise can prevent a person from participating in the clinical study.
6. A person who can take three meals a day basically and prohibit great intemperance during the clinical study.
7. A person who can conduct contraception by an appropriate way during the clinical study.
8. Participant who understands that clinical visits are mandatory during clinical study period.
9. A person who are considered fit for the enrollment in the clinical study.

Key exclusion criteria

The subjects in conflict with any of the following condition are excluded.
1. Have a disorder to absorption, distribution, metabolism, excretion of food, such as digestive tract, liver, kidney, heart and cardiovascular system
2. 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. (Excluding polypectomy and appendectomy)
3. A person with a history of cerebrovascular disorder.(Excluding asymptomatic lacunar infarct)
4. Have a medical history of allergy disease or asthma.
5. A person with hypersensitivity or idiosyncrasy, such as food allergies.
6. Be Suspected alcohol or drug dependence
7. A parson who participated in other clinical trial at resent (past 84 days)
8. A person who has taken the blood sampling 400 mL or 200 mL within 84 days, or platelet apheresis within 14days at the time of starting this trial
11. Have a irregular habit
12. Had participated over the past 3 months, or currently participate in other clinical trials

Target sample size

20


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 Takashi Asama

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

ta1022@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)

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 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=R000037418


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name