THE HEP573 STUDY: A randomised, double-blind, placebo-controlled clinical trial of silymarin alone, and silymarin combined with antioxidants in chronic hepatitis C

Phase 2

Completed

• Conditions: Chronic Hepatitis C; Alternative and Complementary Medicine - Herbal remedies; Alternative and Complementary Medicine - Other alternative and complementary medicine; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12614000966695
• Lead Sponsor: John Hunter Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 216

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;
(11) platelet count less than or equal to 50 x 10 to the power of 9/L;
(12) alcohol intake greater than 70 grams per week;
(13) methadone greater than 100 mg/day or unstable on methadone dose;
(14) non prescription or recreational drugs greater than 3-4 times per week;
(15) pregnant or lactating females;
(16) potential drug-herb interactions, i.e., cyclosporin, warfarin, digoxin, selective serotonin reuptake inhibitor (SSRI), theophylline; and
(17) normal alanine aminotransferase (ALT) levels.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure was the proportion of participants experiencing ALT normalisation from baseline to Week 24. ALT normalisation was defined as a single ALT reading within the normal laboratory range during the treatment period of 24 weeks using Dimension Vista Siemens(Fisher's exact test)[From Baseline to Week 24]