UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000019159|
|Scientific Title||Non-blinded safety verification test using a dose of the test food "EMFCTR-01" five times higher than that intended for healthy individuals|
|Date of disclosure of the study information||2015/10/02|
|Last modified on||2017/09/08|
|Public title||Non-blinded safety verification test using a dose of the test food "EMFCTR-01" five times higher than that intended for healthy individuals|
|Acronym||Non-blinded safety verification test using a dose of the test food "EMFCTR-01" five times higher than that intended for healthy individuals|
|Classification by specialty||
|Classification by malignancy||Others|
|Narrative objectives1||We will check about safety while people take usual "EMFCTR-01" 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) to the second evaluation (visit2) or post evaluation.|
|Basic objectives -Others||We verified the effects of "EMFCTR-01" on other parameters, including organ functionality, through, physical examinations (interview, auscultation, percussion, inspection, palpation, etc.). antioxidative effect, oxidative stress level and changes in clinical laboratory values from the baseline evaluation (visit0) to the second evaluation (visit2) or post evaluation.|
|Primary outcomes||Adverse events|
|Key secondary outcomes||-Body mass index(BMI)
-Blood pressure/pulse/body temperature
-General blood test
-Antioxidative effect and oxidative stress level
-Stool characteristics, stool frequency, stool output
|Basic design||Single arm|
|Blinding||Open -no one is blinded|
|No. of arms||1|
|Purpose of intervention||Prevention|
|Type of intervention||
|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 of Japanese nationality for 20 years.
3) A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy.
4) A person who has freely given consent and has understood the purpose of the study.
5) BMI:18.5 -30.0
6) Blood pressure
Systolic blood pressure : less than 159mmHg
Diastolic blood pressure : less than 99mmHg
7) Pulse rate
8) Body temperature
9) Excessive exercise can prevent a person from participating in the clinical study.
10) Excessive eating can prevent a person from participating in the clinical study.
11) Women of childbearing ages who consent avoidance of the pregnancy during the clinical study.
12) Participant who understands that clinical visits are mandatory during clinical study period.
13) A person who are considered fit for the enrollment in the clinical study.
|Key exclusion criteria||The following exclusion criteria apply to subjects.
1) Use of any prescription drugs or any over-the-counter drugs from -7 day to -1 day before dosing.
2) A person with diseases of the digestive tract, liver, kidney, heart, and circulatory system that might affect test food absorption, distribution, metabolism, and excretion.
3) A person with a lengthy surgical history, including gastrointestinal suture surgery, or intestinal resection. However, polypectomy and appendectomy will not exclude a patient.
4) A person with a history of cerebrovascular disease (asymptomatic lacunar infarction is excluded).
5) A person with tattoo.
6) A person with hypersensitivity or idiosyncrasy, such as food allergies.
7) A person with alcohol or drug dependency.
8) A person who has participated in other clinical trials within 84 days of giving informed consent.
9) A person who has donated 400 ml of blood within 84 days, 200 ml of blood within 28 days, or a blood component (plasma or platelets) within 14 days of giving informed consent.
10) A person trying to become pregnant within the clinical study period.
11) Unable or unwilling to use medically acceptable means of contraception.
12) Nursing or pregnant woman.
13) A person whose diagnosis requires treatment of mental illness by a clinical investigator.
14) A person who is unable to comply with administrative matters during the clinical study.
15) Other people, who are determined ineligible by the clinical investigator.
|Target sample size||10|
|Research contact person|
|Name of lead principal investigator||
|Organization||MEDOC Medical Dock&Clinic|
|Division name||Internal medicine|
|Address||4-3, Yasudadori, Syowa-ku, Nagoya, Aichi, 466-0857, Japan|
|Name of contact person||
|Organization||Medical Fusion Co.,Ltd.|
|Division name||Clinical development division|
|Address||Nagoya Life Science Incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya, Aichi, 464-0858, Japan|
|Institute||Medical Fusion Co.,Ltd.|
|Category of Funding Organization||Profit organization|
|Nationality of Funding Organization|
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|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
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|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Unpublished|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB|
|Anticipated trial start date||
|Last follow-up date||
|Date of closure to data entry|
|Date trial data considered complete|
|Date analysis concluded||
|Other related information|
|Last modified on||
|Link to view the page|
|Registered date||File name|
|Research case data specifications|
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|Research case data|
|Registered date||File name|