A human study for evaluation of the effect of Theracurmin CR-033P on improving hepatic function and satety: 12 weeks, multi-center, double-blind, randomized, placebo-controlled trial

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0002988
• Lead Sponsor: HANDOK INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatic fat(CT)

Secondary Outcome Measures

Name	Time	Method
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)