A human study for investigating effects of Acanthopanax koreanum Nakai extract consumption on hepatic function in moderate drinkers
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001353
- Lead Sponsor
- Jeju Technopark
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 69
1) Wiling to provide own written informed consent to trial participation
2) Adult male & female = 20 years
3) Moderate drinkers
- Male: = 210g of alcohol/week
- Female: = 140g of alcohol/week
4) gamma-Glutamyl Transpeptidase(GGT) = 60 IU/L
5) Proven fatty liver (liver ultrasound)
1) More than or equal to 420 g of alcohol/week
2) Serum alanine Transaminase, aspartate Transaminase or total bilirubin > 5 x upper normal limit
3) Following past medical history
? Viral hepatitis (HBsAg+, HCV-Ab+), liver failure, primary biliary cirrhosis, drug-induced liver disease, biliary disease, autoimmune liver disease, surgery-induced liver disease, hereditary liver disease
? Systemic inflammation(tuberculosis), severe cardiovascular, digestive, renal, thyroid disease, autoimmune disease, malignant neoplasm, multisystem failure, inflammatory bowel disease, psychiatric disease, HIV positive, uncontrolled hypertension
4) Organ or bone marrow transplant recipient
5) Gastro-intestinal surgery (except appendectomy)
6) Concomittent medications
? Anti-tuberculosis, Non-steroidal anti-Inflammatory drugs, antibiotics: isoniazid, rifampin etc.
? Cholagogues: choline orotate, chenodeoxycholic acid, ursodeoxycholic acid etc.
? Liver pills: biphenyl-dimethyl-dicarboxylate, ornithine HCL, silymarin, carnitine orotate, citiolone, arginine thiazolidine carboxylate, coriolan, urazamide, ornithine arspartate, arginine tidiacicate, metadoxine, silybin, malotilate, timonacic etc.
? Hepatotoxic drugs: acetaminophen, amoxicillin, amiodarone, chlorpromazine, ciprofloxacin, diclofenac, erythromycin, fluconazole, methyldopa, oral contraceptives, phenytoin, rifampin etc.
? Anti-epileptics: cytochrom P450 inducer, phenobarbital etc.
7) Continuous consumption of health functional foods (antioxydant vitamin, Oriental Raisin Tree, Anthocyanin, Lentinula edodes, Milk Thistle) within 8 weeks prior to first visit
8) Continuous consumption herbal medicines
9) Hypersensitivity to Acanthopanax koreanum Nakai extract
10) Participation of other clinical study within 12 weeks prior to first visit
11) Pregnant, lactating, child-bearing age women
12) Ineligible for study participation due to other reasons, according to the investigator’s judgment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method gamma-Glutamyl Transpeptidase(GGT);Adverse events
- Secondary Outcome Measures
Name Time Method Alanine Transaminase;Aspartate Transaminase;Lactate Dehydrogenase;Hepatic fat level (Liver-CT)