Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Malonyldiadehyde (MDA)
研究概览
简要总结
The purpose of this study is to determine the efficacy of antioxidant cocktails on the alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.
详细描述
60 cases of beta-thalassemia/Hb E patients. All patients will be diagnosed with hemoglobin typing of beta-thalassemia/Hb E disease and not receive blood transfusion or any treatment at least 3 months prior study. The study will be randomized controlled trial that designed before and after treatment with antioxidant cocktail. The antioxidant cocktail consists of vitamin E 400 IU/day, curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day. All patients will receive antioxidant cocktail daily for 12 months. The patients will be regularly followed up and analyzed biochemical parameters every two months during treatment and after withdrawal for 3 months.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18-50 years
- •hemoglobin level between 6-9 g/dL during screen visit
- •WHO performance status grade 0-2
- •signed in informed consents prior to the study entry.
排除标准
- •receiving iron chelator and blood transfusion.
- •pregnancy or breastfeeding
- •receiving other drugs except folic acid at least 30 days before study.
研究组 & 干预措施
Curcuminoids
The administrate curcuminoids is intervention for 30 patients
干预措施: curcuminoids, N-acetylcysteine, deferiprone and vitamin E (Drug)
Curcuminoids
The administrate curcuminoids is intervention for 30 patients
干预措施: Curcuminoids and alpha-tocopherol (Drug)
Vitamin E
The vitamin E is intervention for 30 patients
干预措施: curcuminoids, N-acetylcysteine, deferiprone and vitamin E (Drug)
Vitamin E
The vitamin E is intervention for 30 patients
干预措施: Curcuminoids and alpha-tocopherol (Drug)
结局指标
主要结局
Malonyldiadehyde (MDA)
时间窗: 1 year after treatment with antioxidant cocktail.
Lipid peroxidation will be assayed by measuring the formation of malonyldialdehyde (MDA). The formation of MDA on red blood cell will be exposed by hydrogen peroxide. Then, MDA will be extracted by trichloroacetic acid (TCA) and will be reacted with thiobarbituric acid (TBA) in boiling condition to MDA-TBAR complex. This complex will be given pink color and measuring at 532 and 600 nm
次要结局
未报告次要终点