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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT02734966
Eligibility Criteria:
Inclusion Criteria:
* RACUM ≥6
* ALTs ≥2ULN, but TBiL is ≤ 3 ULN.It may be associated with AST or ALP or TBiL exceed the upper limit of normal
* Liver biochemical abnormalities duration of no more than three months
* Patients need to fully understand and sign the inform consent form.
Exclusion Criteria:
* The liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease.
* The patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is ≤ 35g/L, prothrombin time is elongated more than 2 seconds compared to its normal range.
* The value of the TBiL is \> 3ULN.
* The value of serum creatinine is \> 1.5ULN.
* Patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract.
* Patients who are taking the drugs that might interfere the trial.
* Patients who are allergic or intolerant to the study drug.
* Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis.
* Patients who are compliant with protocol.
* Women who are pregnant, breast-feeding or with childbearing potential.
* Patients who have attended other clinical trials within 3 months.
* Not appropriate to be included after assessing by the investigators.
ULN=Upper Limited Normal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02734966
Study Brief:
Protocol Section:
NCT02734966