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
- Conditions
- Healthy person
- Registration Number
- JPRN-UMIN000020607
- Lead Sponsor
- Medical Fusion Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events period : from Visit0 to Visit3
- Secondary Outcome Measures
Name Time Method -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