UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000020607 |
| Receipt No. | R000023788 |
| Official scientific title of the study | Efficacy and long-term safety trials - Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose - |
| Date of disclosure of the study information | 2016/01/18 |
| Last modified on | 2017/09/08 (Ver. 18) |
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| Basic information | ||
| Official scientific title of the study | Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose - |
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| Title of the study (Brief title) | Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose - |
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| Condition | ||
| Condition | Healthy person | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | We will check about safety while people take usual or 3times-dose "EMFCTR-01" for 12 weeks.
We evaluated safety through physical examinations (interviews, auscultation, percussion, inspection, palpation, etc.), changes in clinical laboratory values, and diary by subject from the baseline evaluation (vist0) to the third evaluation (visit3) or post evaluation. |
| Basic objectives2 | Others |
| Basic objectives -Others | We evaluated Efficacy of the test food "EMFCTR-01" through the fecal status from the next day after obtaining informed consent to Visit3. Also, we verified the effects of "EMFCTR-01" on other parameters, including organ functionality, through, physical examinations (interview, auscultation, percussion, inspection, palpation, etc.), and changes in clinical laboratory values from the baseline evaluation (visit0) to the third evaluation (visit3) or post evaluation. |
| Trial characteristics_1 | Confirmatory |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Adverse events
period : from Visit0 to Visit3 |
| Key secondary outcomes | -Physical signs, physical symptom, primary disease, complications, anamnesis, history of present illness
-Concomitant medications, adjunctive therapy -Blood pressure/pulse -Body temperature -Height, Weight, Body mass index(BMI) -12-lead electrocardiogram -General hematology tests -Blood biochemistry tests -Urinalysis -The fecal situation (fecal frequency, fecal volume , fecal property) -Meal recording -State of facial skin as examined by Robo Skin Analyzer RSA50. -State of hair as examined by Mobile Skin Analyzer AOT-ST. -Blood pressure pulse wave -Hardness of muscle -CT examination |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Randomized |
| Randomization unit | Individual |
| Blinding | Double blind -all involved are blinded |
| Control | Placebo |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | Numbered container method |
| Intervention | ||
| No. of arms | 3 | |
| Purpose of intervention | Prevention | |
| Type of intervention |
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| Interventions/Control_1 | dosing period : 12 weeks
dose : usual dose ("EMFCTR-01"concentration 11mL/33mL) frequency : once a day |
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| Interventions/Control_2 | dosing period : 12 weeks
dose : 3 times dose 33mL ("EMFCTR-01"concentration 33mL/33mL) frequency : once a day |
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| Interventions/Control_3 | dosing period : 12 weeks
dose : plasebo 33mL ("EMFCTR-01"concentration 0mL/33mL) frequency : once a day |
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| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Target subjects must satisfy the following selection criteria.
-Healthy Japanese men and women aged more than 30 years, less than 55 years at the time of giving informed consent. -A person of Japanese nationality for 20 years. -A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy. -A person who has freely given consent and has understood the purpose of the study. -A person whom the tendency of the property of the feces(the score of the property of the feces/days) is less than 2.5 from the next day of the agreement acquisition day to -1 day. -BMI:18.5 -30.0 -Blood pressure Systolic blood pressure:less than 159mmHg Diastolic blood pressure:less than 99mmHg -Pulse rate:50-100 times/minute -Body temperature:35.5-37.0 degrees -Excessive exercise can prevent a person from participating in the clinical study. -A person who can take three meals a day basically and prohibit great intemperance during the clinical study. -A person who can conduct contraception by an appropriate way during the clinical study. -Participant who understands that clinical visits are mandatory during clinical study period. -A person who are considered fit for the enrollment in the clinical study. |
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| Key exclusion criteria | The following exclusion criteria apply to subjects.
-Use of any prescription drugs or any over-the-counter drugs from -7 day to -1 day before dosing. -A person who have used the steroid drug within the past three months of consent acquisition date. -A person with diseases of the digestive tract, liver, kidney, heart, and circulatory system that might affect test food absorption, distribution, metabolism, and excretion. -A person with a lengthy surgical history, including gastrointestinal suture surgery, or intestinal resection. However, polypectomy and appendectomy will not exclude a patient. -A person with a history of cerebrovascular disease (asymptomatic lacunar infarction is excluded). -A person with tattoo. -A person with hypersensitivity or idiosyncrasy, such as food allergies. -A person with alcohol or drug dependency. -A person who has participated in other clinical trials within 84 days of giving informed consent. -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. -The person who hopes for pregnancy or the person who can't prevent conception during the clinical study. -Nursing or pregnant woman. -A person whose diagnosis requires treatment of mental illness by a clinical investigator. -A person who housemate is participating or a plan to participate in this clinical study. -A person with taking "tenshi no Lara" within the past for 1 year from an agreement acquisition day. -A women who is postmenopausal -A person who are engaged in night duty. -The person doing the hair dyeing, the permanent wave and the frizzled hair correction, etc. which have an influence on a hair and scalp. -A person who is unable to comply with administrative matters during the clinical study. -A person who are determined ineligible by the clinical investigator. |
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| Target sample size | 45 | |||
| Research contact person | |
| Name of lead principal investigator | Hitoshi Yoshida |
| Organization | MEDOC Medical Dock&Clinic |
| Division name | Internal medicine |
| Address | 4-3, Yasudadori, Syowa-ku, Nagoya, Aichi, 466-0857, Japan |
| TEL | 052-752-1135 |
| chiken@medoc.jp | |
| Public contact | |
| Name of contact person | Hiromichi Hayashi |
| 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 |
| TEL | 052-745-3300 |
| Homepage URL | http://www.m-fusion.co.jp/ |
| info@m-fusion.co.jp | |
| Sponsor | |
| Institute | Medical Fusion Co.,Ltd. |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Eminet Co.,Ltd. |
| Organization | |
| Division | |
| Category of Funding Organization | Profit organization |
| Nationality of Funding Organization | |
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| Name of secondary funｄer(s) | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
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| Date of disclosure of the study information |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Related information | |
| URL releasing protocol | |
| Publication of results | Unpublished |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023788 |
