Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT04555434
Eligibility Criteria:
Inclusion Criteria:
1. Those who agreed to participate in this study and signed a written consent
2. Adult men and women over 20
3. Patients diagnosed with non-alcoholic fatty liver
※ Exclusion criteria for alcoholic liver disease
* Those who have an alcoholic drinking ability of at least 60g per day for at least one year before visiting (30g for women)
* 1 bottle of shochu 360 ml \* 20% = 72 g, 1 bottle of beer 500 ml (330 ml for commercial use) \* 5% = 25 (16.5 g)
4. Patients with higher liver numbers than normal ※ Adult normal liver level range by enzyme
* AST, ALT: 40 or less
* ALP: 20-130
* GOT: 0-30, GPT: 0-38
* GGT: 10-62 (male), 7-35 (female)
Exclusion Criteria:
1. Those who have consumed probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk, etc. within the past month.
2. Those who have continuously taken antibiotics within the last 2 months or who are likely to take them during the study period
3. Those who have continuously consumed medicines or health functional foods that affect liver function within the past month.
4. Those who have participated in other clinical trials within the past 1 month (but not applicable to medical device clinical trials)
5. If you have any of the following
* Alcoholic liver disease, hereditary metabolic disease, autoimmune hepatitis
* systemic inflammatory disease or immune disease
* Hepatocellular carcinoma
* Uncontrolled cardiopulmonary disease
* Other serious systemic disorders in the heart, lungs, blood, and endocrine system
6. A person with a history of malignancy diagnosis within the last 5 years
7. Pregnant or lactating women
8. Persons who have hypersensitivity to the test drug / placebo or components contained in the test drug / placebo or have severe allergic reactions
9. Those who are not suitable for the clinical trial because the investigator judges
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
62 Years
Study:
NCT04555434
Study Brief:
Protocol Section:
NCT04555434