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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032817
Receipt No. 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

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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
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 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=R000037418

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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