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:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT01634256
Eligibility Criteria:
Inclusion Criteria:
* Males and females 19-70 years old
* Mild hepatic injury as indicated by ALT(Alanine Transaminase) level ≥ 40
* Able to give informed consent
Exclusion Criteria:
* Allergy or hypersensitivity to any of the ingredients in the test products
* History of reaction to any of the experimental products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* Carriers of viral hepatitis (type B and C)
* History of underlying Esophageal varices, hepatic encephalopathy, ascites(past 12 months)
* Participation in other clinical trials within the past 2 months
* Patients with acute hepatitis (type B and C)
* History of underlying cirrhosis and liver cancer
* History of underlying biliary diseases such as jaundice or gallstones
* History of underlying kidney disease such as Chronic renal failure or nephrotic syndrome
* Pregnant, planning to become pregnant, or breast-feeding
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT01634256
Study Brief:
Protocol Section:
NCT01634256