None listed
Conditions
Interventions
Dietary Supplement : Subjects take placebo or Theracurmin CR-033P twice a day (1 capsules/time) for 12 weeks
Sponsors
HANDOK INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject who voluntarily agrees to participate and signs in informed consent form 2) 20 = Age < 75 years 3) Subject who has fatty liver 4) 40 < one or more of ALT or AST < 120
Exclusion criteria
Exclusion criteria: 1) Subjects with High quality of the meal (recommended food score > 36) 2) Subjects who constantly performed severe exercises at least 10 hours per week 3) Chronic smoker (= 20 cigarettes/d) 4) alcoholics or Subjects who usually drink alcohol as follows -male = 210 g / week (3.5 bottles of soju/week, 4 glasses/day) -female = 140 g / week (2.5 bottles of soju/week, 3 glasses/day) 5) BMI: < 23kg/m2 or = 35kg/m2 6) Subject with following diseases and past medical history ? diseases related hepatic function -viral hepatitis -serious liver disease(hepatic insufficiency, etc.) primary biliary cirrhosis, drug-induced liver disease -autoimmune liver disease -liver disease induced by drug or operation, inherited liver disease ? infectious disease (tuberculosis, etc.), serious cardiovascular disease, disease of digestive system, renal disease, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, Inflammatory Bowel Disease, serious mental illness,HIV positive ? who has continuous symptom releated with gastrointestinal diseases (brash, dyspepsia etc.) 7) Received organ transplantation or bone marrow transplantation 8) Be applicable to one or more - AST or ALT = 120 U/L - ALP = the upper limit of normal levels(ULN)?3 - Platelet = 105/mL or a-fetoprotein > 20 ng/mL - Albumin =3.3 g/dL or total bilirubin = 3 mg/dL - Creatinine = the upper limit of normal levels(ULN)?2 - HbA1c = 7.0% 9) Predicted to use prohibited drugs 10) Administration of drugs that affect liver function within 12 weeks before the first visit (medication for hyperlipidemia,antidiabetics, high dose of estrogen or administration of steroid over 14 days (but, medication of antihypertensives and antihyperlipidemia(such as statin) is permitted, as long as they had been used at a constant dosage/commenced at least 3 months prior to the study/be expected to maintain the dosage during the study) 11) Continuous consumption of dietary supplements or oriental medicine within 4 weeks before the first visit 12) Subjects with hypersensitivity to test materials 13) Participation in other human study within 12 weeks before the first visit 14) Pregnant or lactating women 15) Any condition that the principal investigator believes may put the subjects at undue risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic fat(CT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological test(WBC, RBC, Hb et al.), Blood chemical test(ALP, BUN, creatinine et al.), Urine test(pH, protein, glucose et al.);Hepatic function related markers(ALT, AST, GGT) | — |
Countries
Korea, Republic of
Contacts
Public ContactSoyeong Park
Bundang CHA General Hospital
Outcome results
None listed