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 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT00755950
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of acute viral hepatitis (\<1 month) as manifested by a combination of the following symptoms: jaundice, dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, aversion to smoking and right upper abdominal discomfort, pain or feeling of pressure.
* Serum ALT level \> 2.5 times the upper limit of normal.
* Albumin level \>3.5 gm/dl
* Negative anti-HCV antibody
* Males and females \>= 18 years of age.
* Subject has given written informed consent. If patient is between 18 and 21 years parents/legal guardian have/has also signed the informed consent form.
* The subject is able and willing to undertake all study-required procedures and has the ability to take oral medications.
Exclusion Criteria:
* Subjects \< 18 years of age
* Pregnant or breastfeeding women
* Suspected hypersensitivity to silymarin or multivitamins
* Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy)
* Chronic liver disease as cirrhosis
* Subjects with positive anti-HCV antibody
* Simultaneous elevation of bilirubin \> 10 mg/dl along with an ALT level between 100 and 150 U/L
* Platelets count \<150,000
* Subjects with morbid obesity i.e. a Body Mass Index (BMI) \> 40
* Subjects with severe illness, e.g., multisystem failure, cancer or poorly controlled diabetes i.e. known diabetic with Hemoglobin A1C (HbA1C)\>7%
* Obvious history of drug-induced acute hepatitis. A careful history of all medications, pesticide and other hepatotoxic exposures occurring within one month prior to symptom onset will be taken. If a patient is unaware of the name of the drugs, (s)he will be asked to bring it for inspection.
* Current use of Silymarin or recent use within past two weeks.
* Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of, the protocol (e.g. severe mental illness)
* The subject is currently participating in any clinical trial (marketed product or otherwise), or has done so within 30 days or 5 half-lives (whichever is longer) prior to screening visit
* History or current drug or alcohol abuse
* Female patient with childbearing potential without negative pregnancy test
* Patient is known to be HIV positive.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00755950
Study Brief:
Protocol Section:
NCT00755950