None listed
Conditions
Interventions
Dietary Supplement : Subjects were
-White ginseng extract group: 2 capsules per day, 3 capsules per day, morning and evening meal intake (3 g / day, white ginseng extract 2.4 g / day)
-Placebo:2 caps
Sponsors
International Ginseng & Herb Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT, GGT variation | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function indicator (AST, ALP, total bilirubin);Fatty Liver Index (FLI);Antioxidant Index Test (TAS);Multidimensional Fatigue Scale (MFS);Adverse events;Vital signs | — |
Countries
Korea, Republic of
Contacts
Public ContactBong Song
Wonkwang University
Outcome results
None listed