A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract -Open Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000034469
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
(1) Subjects who are under treatment with medications. (2) Subjects who contract or are undertreatment for serious diseases (e.g., kidney disease, liver disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease). (3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) during test periods. (4) Subjects who can't stop drinking from 2 days before each measurement. (5) Subjects who have declared allergic reaction to ingredients of test foods. (6) Subjects who have donated over 400mL of blood and/or bood components within the last three months prior to study initiation. (7) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating. (8) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (9) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study. (10) Subjects who are judged as unsuitable for the current study by the investigator or subinvestigators for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Doctor's questions, Vital signs, Hematological test, Blood biochemical test, Urinalysis, Adverse event
- Secondary Outcome Measures
Name Time Method