Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Serum ferritin level
研究概览
简要总结
Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective and iron chelating activities. The present study has been designed to investigate the therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 6-month randomized, double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy or the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are assessed at the beginning and the end of the trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of major Beta-thalassemia
- •Age 12 years or older
- •Iron overload condition (serum ferritin levels between 1000-5000 ng/mL) Regular desferrioxamine administration (50 mg/kg)
- •Continuous blood transfusions
- •Negative CRP test
- •Exclusion criteria:
- •Hepatitis B or C infection
- •Positive HIV test
- •Chronic renal or heart failure
- •Iron chelating therapy with other iron chelators
排除标准
- 未提供
研究组 & 干预措施
Silymarin (LEGALON)
干预措施: Silymarin (LEGALON) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Serum ferritin level
时间窗: after 3 months and 6 months from beginning of the trial
次要结局
- Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels(At the beginning and the end of the trial)