Safety overdose study intake foods containing plant extracts
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000053541
- Lead Sponsor
- Miura Clinic, Medical Corporation Kanonkai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 15
Not provided
(1)Subjects with a history of diabetes, liver disease, renal disease, gastrointestinal disease, heart disease, respiratory disease, peripheral angiopathy, or other serious disease (2)Subjects who have undergone gastrointestinal surgery (3)Subjects with abnormal liver and renal function test values (4)Subjects who are currently undergoing treatment for a disease (5)Subjects who are allergic to food or drugs (6)Subjects with anemia symptoms (7)Women who wish to become pregnant (including possible pregnancy) or lactating women during participation in this study (8)Subjects who play intense sports and subjects who are on a diet (9)Subjects with extremely irregular eating habits (10)Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (11)Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs) (12)Subjects who drink more than 60 g of average daily pure alcohol (13)Subjects who smoke an average of 21 or more cigarettes a day (14)Subjects who are participating or will participate in other clinical trials at the start of this study (15)Subjects who are judged to be unsuitable for the study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event Physical examination (blood pressure, pulse) Laboratory test values (Hematology, blood biochemistry, urinalysis)
- Secondary Outcome Measures
Name Time Method