Human body test for evaluating the efficacy and safety of white ginseng extract for liver functio
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0004080
- Lead Sponsor
- International Ginseng & Herb Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ALT, GGT variation
- Secondary Outcome Measures
Name Time Method iver function indicator (AST, ALP, total bilirubin);Fatty Liver Index (FLI);Antioxidant Index Test (TAS);Multidimensional Fatigue Scale (MFS);Adverse events;Vital signs