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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023668
Receipt No. R000027262
Scientific Title The verification study for safety evaluation of test food overdose in human: an open-label trial
Date of disclosure of the study information 2017/06/19
Last modified on 2017/02/01

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Basic information
Public title The verification study for safety evaluation of test food overdose in human: an open-label trial
Acronym The verification study for safety evaluation of test food overdose in human
Scientific Title The verification study for safety evaluation of test food overdose in human: an open-label trial
Scientific Title:Acronym The verification study for safety evaluation of test food overdose in human
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the safety of overdose the test food
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Body measuring
2. Physical examination
3. Internal medicine examination
4. Blood test
5. Urinalysis
6. Subjective symptom
*1 Perform examinations and tests at 0 week and at 2 and 4 weeks after the ingestion and at follow-up period 2 weeks
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 4 weeks
Follow-up duration: 2 weeks
Test material: "Garlic egg yolk 229-55 ninnikugogo"
Dose: Take five capsules, three times a day
Administration: Take five capsules after each meal
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adults
Key exclusion criteria 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Currently taking medicines and/or herbal medicines

4. Allergic to medicines or foods related to the test food of this trial

5. Pregnant, lactating, or planning to get pregnant during the trial period

6. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial

7. Judged unsuitable for participating in this trial by physician
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization Temahimado Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor 1. Seishin-kai Medical Association Inc, Takara Medical Clinic.

2. Evaluation Center of Health and Nutrition 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 医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Suzuki N, Yamamoto K, Kakino K, Takara T. Safety Evaluation of the Safety of Excessive Ingestion of Garlic-egg Yolk-containing Supplements in Humans-An Open-label Trial-. Jpn Pharmacol Ther. 2016; 44(12): 1795-1819.
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
2015 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 14 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
2016 Year 08 Month 18 Day
Last modified on
2017 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027262

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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