NCT01935817已完成3 期
Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- transforming growth factor beta
研究概览
简要总结
Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC.
The investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older,
- •infection by HCV
- •under treatment with pegylated interferon 2 alpha and ribavirin
排除标准
- •other liver diseases
- •severe jaundice
- •pulmonary and renal chronic diseases
- •prostatic diseases
- •autoimmune diseases
- •diabetes mellitus
研究组 & 干预措施
Silybin + vitamin E + phospholipids complex
Active Comparator
Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months
干预措施: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex (Drug)
sugar pill
Placebo Comparator
one placebo pill per day for 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
transforming growth factor beta
时间窗: 12 months
serum marker of liver fibrosis
次要结局
- hyaluronic acid(12 months)
研究者
Mariano Malaguarnera
A.P.
University of Catania
研究点 (1)
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