ACTRN12614000966695
Completed
Phase 2
In compensated chronic hepatitis C patients, what is the effect of silymarin alone or silymarin combined with antioxidants compared to placebo on the proportion of hepatitis C patients with ALT normalisation at week 24 compared to baseline?
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C
- Sponsor
- John Hunter Hospital
- Enrollment
- 216
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) able to give informed consent;
- •(2\) aged between 18 and 75 years;
- •(3\) hepatitis C antibody and HCV RNA positive;
- •(4\) abnormal liver tests on at least three occasions in the past two years;
- •(5\) prepared to stop Western and Chinese herbs, vitamins and nutritional supplements used in the Study for the study duration and for a wash out period of 12 weeks prior to trial entry;
- •(6\) prepared to visit the hospital site monthly for blood tests and to complete questionnaires;
- •(7\) stable on their methadone dose and less than 100 mg daily dose; and
- •(8\) women were prepared to practice two methods of contraception during the Study period.
Exclusion Criteria
- •(1\) Alcohol\-related liver disease;
- •(2\) alpha 1\-antitrypsin deficiency;
- •(3\) autoimmune hepatitis;
- •(4\) drug\-induced liver disease;
- •(5\) haemochromatosis;
- •(6\) hepatitis B and D;
- •(7\) decompensated cirrhosis (Child\-Pugh Score greater than 7\);
- •(8\) human immunodeficiency virus (HIV);
- •(9\) non\-alcoholic steatohepatitis;
- •(10\) antiviral therapy (pegylated interferon and ribavirin) in the past six months;
Outcomes
Primary Outcomes
Not specified
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