A human study for investigating effects of Acanthopanax koreanum Nakai extract consumption on hepatic function in moderate drinkers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001353

Enrollment

Registered

2015-01-20

Start date

2013-11-14

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Oral administration of Acanthopanax koreanum Nakai extract low-dose(1.5g/day), high-dose(3g/day) or placebo, twice daily for sixteen weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
gamma-Glutamyl Transpeptidase(GGT);Adverse events	—

Secondary

Measure	Time frame
Alanine Transaminase;Aspartate Transaminase;Lactate Dehydrogenase;Hepatic fat level (Liver-CT)	—

Countries

Korea, Republic of

Contacts

Public ContactDOO-YEOUN CHO

Ajou University Hospital

dyc74@naver.com+82-31-219-4271

Outcome results