KCT0004080已完成未知
A 12-week, multi-center, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of white ginseng extract on Liver function
International Ginseng & Herb Research Institute0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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) Adults and adults aged 19 to 70 years at the time of screening
- •2) Those whose serum ALT level exceeds the upper limit of reference range of research institute
- •3) Those who have heard the full explanation of this human application test, fully understand it, and have voluntarily decided to participate and have agreed in writing to comply with the precautions.
排除标准
- •1) A person whose serum ALT level exceeds 3 times the upper limit of the reference range of the research institute
- •2) Those taking liver function improvement medicines and health functional foods within 4 weeks before screening
- •3) Those who have received antipsychotic medication within 2 months before screening
- •4) Those taking Chinese medicine within 4 weeks of the first day of administration (However, if the other conditions are reasonable according to the judgment of the tester, they can participate in the study.)
- •5) Those who are suspected of drug or alcohol addiction
- •6) Those who have a history of clinically significant hypersensitivity to ginseng or red ginseng
- •7) Applicable to persons with a history of gastrointestinal diseases (eg Crohn's disease) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
- •8) Those with at least one history of esophageal variceal bleeding, hepatic coma, ascites, etc. within 1 year before the first administration
- •9) Patients with acute and chronic hepatitis (hepatitis B and C)
- •10) hepatitis virus (hepatitis B and C hepatitis virus) carriers
- •11) Those with clinically significant acute or chronic cardiovascular, endocrine, immune, respiratory, hepatic, urinary, neuropsychiatric, musculoskeletal, inflammatory
- •12) Persons with signs of cirrhosis, liver cancer or liver cancer
- •13) Those with an average alcohol consumption of 21 unit / week or more within 3 months before screening
- •14) Pregnant or lactating women
- •15) If there is a possibility of pregnancy among the pregnant women who do not accept the implementation of the appropriate contraceptive method (except for women who have undergone sterilization)
- •16) Those who participated in the application test for the human body within 2 months before the screening test
- •17) Diagnostic test Those who showed the following results in medical examination ? Serum Creatinine> 2.0 mg / dL
- •18) Diagnostic test A person who is determined to be ineligible for participation in the study due to medical examination result or other reasons
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