A human study for evaluation of effectiveness and safety of Perilla frutescens Britton extract consumption on improving hepatoprotective and antioxidative capacity
- Conditions
- Not Applicable
- Registration Number
- KCT0000911
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1) Subject who voluntarily agrees to participate and signs in informed consent form
2) Age: = 20 years
3) BMI: = 25kg/m2 and = 35kg/m2
4) ALT or AST: = the upper limit of normal levels(ULN)?1.5 and < ULN?5
1) Chronic smoker (= 20 cigarettes/d)
2) Heavy drinker(= 420g/week)
3) Subject with following diseases and past medical history
? viral hepatitis, liver dysfunction, serious liver disease, primary biliary cirrhosis, drug-induced liver disease, autoinnune liver disease, inherited liver disease
? General infectious disease (included tuberculosis), serious CVD, renal disease, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, ulcerative colitis, uncontrolled mental illness, HIV
4) Received organ transplantation or bone marrow transplantation
5) Predicted to use prohibited drugs
6) Administration of drugs that affect liver function within 6 months before the first visit or administration of steroid over 14 days
7) Consumption of dietary supplements or oriental medicine that affect liver function and antioxidative capacity within 8 weeks before the first visit
8) Subjects with hypersensitivity to test materials
9) Participation in other human study within 12 weeks before the first visit
10) Pregnant or lactating women
11) Any condition that the principal investigator believes may put the subjects at undue risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Markers of hepatic function
- Secondary Outcome Measures
Name Time Method Antioxidative markers, etc.