Randomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in … (NCT00755950) | Clinical Trial Compass
TerminatedPhase 2/3
Randomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in Patients With Acute Viral Hepatitis
Stopped: Low enrollment
Egypt70 participantsStarted 2008-10
Plain-language summary
The purpose of this study is to assess whether two higher doses (280mg or 420mg three times daily)of silymarin therapy are safe and tolerable, and shorten the illness in patients with acute viral hepatitis compared to placebo.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
What they're measuring
1
Incidence, severity and duration of Adverse Events
Timeframe: Four weeks after enrollment
2
Normalization of total (<1.0 mg/dl) and direct bilirubin (<0.3 mg/dl)