ACTRN12614000966695已完成2 期
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?
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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.
研究者
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