Status:
TERMINATED
Randomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in Patients With Acute Viral Hepatitis
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
MADAUS GmbH
The Egyptian Company for Blood Transfusion Services
Conditions:
Acute Hepatitis A
Acute Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 hepa...
Detailed Description
Currently, acute viral hepatitis (AVH) management is based on diet and rest and silymarin remains among the most popular herbs being used for treating viral hepatitis both in the U.S. and abroad. Alth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00755950
Start Date
October 1 2008
End Date
December 1 2015
Last Update
April 23 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Alexandria University Hospital
Alexandria, Alexandria Governorate, Egypt
2
Tanta Fever Hospital
Tanta, Gharbeya Governorate, Egypt
3
Banha Fever Hospital
Banhā, Kaluobeya Governorate, Egypt