KCT0001353已完成未知
A human study for investigating effects of Acanthopanax koreanum Nakai extract consumption on hepatic function in moderate drinkers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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