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 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT03738358
Eligibility Criteria:
Inclusion Criteria:
* Age between 19-year-old and 79-year-old
* Weight (≥50kg)
* Is diagnosed as fatty liver on ultrasonography within 24 weeks from screening day
* Has willingness and ability to participate whole clinical study period
* Willing to give informed consent form
Exclusion Criteria:
* Patient with alcoholic fatty liver
* Patient with inflammatory bowel disease
* Is required treatment for like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study
* Has any medical history with virus or toxic hepatitis
* Has any medical history of gastrointestinal surgery (except simple appendectomy \& repair of hernia)
* Has medical history of malignant tumor (except non-melanoma skin cancer) within the last 5 years from the screening day
* Took any drugs (UDCA, silymarin, omega-3, fenofibrate etc.) which is decided as unsuitable drug for combined-dose by investigator
* Over 4 times of maximum reference range of ALT or AST
* Average drinking quantity per week \> alcohol 140 g
* Pregnant or nursing women
* Is currently participating into another clinical study
* Being made a decision from investigator as unsuitable to participate this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
79 Years
Study:
NCT03738358
Study Brief:
Protocol Section:
NCT03738358