Back to resultsEfficacy of Silymarin for Acute Hepatitis
Primary Purpose
Hepatitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Silymarin (Silybum marianum)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis focused on measuring Acute hepatitis, Acute viral hepatitis, Acute nonviral hepatitis, Silymarin, Milk Thistle
Eligibility Criteria
Inclusion Criteria:
- Patients admitted to the fever hospital and presenting with symptoms and signs that may be consistent with a diagnosis of acute hepatitis.
- Recent (<1 month) history of illness.
- Elevation of ALT > 2.5 normal.
- At least 13 years old.
Exclusion Criteria:
- History suggestive of severe drug-induced acute hepatitis.
- Children 12 years and younger.
- Pregnant or breastfeeding women
- Suspected hypersensitivity to Silymarin or vitamin preparations.
- Evidence of advanced liver disease e.g. history or presence of ascitis, bleeding esophageal varices, and hepatic encephalopathy.
- Patients who are critically ill, with multisystem failure or cancer.
- Substance abuse such as IV drugs.
- Any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment or could interfere with the patient's participation in and completion of the protocol.
Sites / Locations
Outcomes
Primary Outcome Measures
Primary outcomes were symptoms and signs of acute hepatitis and results of liver function tests on days 3, 5 and 7 in the hospital and in the outpatient clinic at weeks 2, 4, and 8.
Secondary Outcome Measures
Side-effects and adverse events were ascertained by self-report on days 3, 5 and 7 in the hospital and in the outpatient clinic at weeks 2, 4, and 8. .
Full Information
NCT ID
NCT00412763
First Posted
December 15, 2006
Last Updated
April 21, 2021
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT00412763
Brief Title
Efficacy of Silymarin for Acute Hepatitis
Official Title
Efficacy of Silymarin for Treatment of Acute Hepatitis In Egypt: A Randomized, Double-Blinded, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
5. Study Description
Brief Summary
The overall objective of this project is to assess whether Silymarin therapy shortens illness or prevents complications in patients with acute hepatitis. We will specifically compare responses in acute hepatitis patients treated with Silymarin to those given a control preparation of a vitamin supplements in a double blinded, randomized, placebo-controlled trial.
Detailed Description
The study is designed as a double-blinded placebo controlled trial. We compare a 4 week course of therapy with silymarin tablets and a low-dose vitamin preparation (placebo) and then follow-up for a total of 8 weeks to assess treatment response. Outcomes of our randomized controlled trial are improvement in symptoms and signs, normalization of liver functions, time to resuming normal activities, and and sense of well-being. This protocol follows the standard therapeutic care for acute hepatitis except that the patients will receive either a herbal supplement (silymarin), which many patients are taking anyway, or a vitamin placebo.
Freshly collected serum will be tested for anti-HAV IgM, anti-HBc Igm, anti-HBs, HBs Ag, anti-HCV antibody, HCV-RNA, anti-HDV IgM, anti-HEV IgM, CMV and EBV and for alanine aminotransferase (ALT), AST, direct and total bilirubin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis
Keywords
Acute hepatitis, Acute viral hepatitis, Acute nonviral hepatitis, Silymarin, Milk Thistle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Silymarin (Silybum marianum)
Primary Outcome Measure Information:
Title
Primary outcomes were symptoms and signs of acute hepatitis and results of liver function tests on days 3, 5 and 7 in the hospital and in the outpatient clinic at weeks 2, 4, and 8.
Secondary Outcome Measure Information:
Title
Side-effects and adverse events were ascertained by self-report on days 3, 5 and 7 in the hospital and in the outpatient clinic at weeks 2, 4, and 8. .
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted to the fever hospital and presenting with symptoms and signs that may be consistent with a diagnosis of acute hepatitis.
Recent (<1 month) history of illness.
Elevation of ALT > 2.5 normal.
At least 13 years old.
Exclusion Criteria:
History suggestive of severe drug-induced acute hepatitis.
Children 12 years and younger.
Pregnant or breastfeeding women
Suspected hypersensitivity to Silymarin or vitamin preparations.
Evidence of advanced liver disease e.g. history or presence of ascitis, bleeding esophageal varices, and hepatic encephalopathy.
Patients who are critically ill, with multisystem failure or cancer.
Substance abuse such as IV drugs.
Any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment or could interfere with the patient's participation in and completion of the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George T Strickland, MD, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Efficacy of Silymarin for Acute Hepatitis
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