KCT0003985已完成未知
A 12 week, randomized, double blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Lycium chinense fruit extract (LFE) on improving liver function in subject with impaired hepatic function
Cheongyang-Gun Rich Farm Support Center0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) 19 ~ 70 years of age
- •2) ALT level 35~105 IU/L
- •3) Subjects who agree to participated in the study and sign the informed consent form
排除标准
- •1) AST or GGT > 3-fold of normal range
- •2) Subjects who usually drink alcohol as follows within 3 months
- •-Male > 210 g/weeks
- •-Female > 140 g/weeks
- •3) Patients with acute or chronic hepatitis or carriers of viral hepatitis (type B or C)
- •4) History of underlying cirrhosis and liver cancer
- •5) History of underlying biliary diseases such as jaundice or gallstones (But, asymptomatic gallstones etc. can be enrolled under the judgment of the researcher)
- •6) Major medical illness such as cardiovascular, neurologic, hepatic, musculoskeletal system, psychiatric, endocrine system, immune, renal, malignant tumor and pulmonary disease etc.
- •7) Administration of drugs that affect liver function (antiviral drugs, antituberculosis drugs, antiseizure drugs, arthrifuge, antidepressant, lipid-lowering agents, anesthetic agents, hepatoprotective agents, NSAIDs etc.), adrenal cortex hormones or sex hormone within 4 weeks
- •8) Taking the liver function improving supplements (Milk thistle etc.), oriental medicine, OTC(Over The Counter) within 2 weeks
- •9) Allergic or hypersensitivity to drug and any of the ingredients in the test products (Lycium chinense, crystalline cellulose etc.)
- •10) History of substance abuse
- •11) History of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
- •12) Participation in other clinical trials within the previous two months
- •13) Pregnant, planning to become pregnant, or breast-feeding
- •14) emale subjects of childbearing potential who are not willing to use appropriate contraception (except for surgery for female infertility)
- •15) Laboratory test by show the following results
- •? Serum creatinine > 2.0 mg/dL
- •16) Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
研究者
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