Impact of antioxidant cocktail in treatment of transfusion dependent beta thalassemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Hb level
研究概览
简要总结
The subjects will be divided into 2 equal groups . one group will be treated with a antioxidant cocktail for 12 months. That group will receive Vit-E 400 IU/day, 200mg/day NAC, and 50mg/kg/day DFP. And other group will not receive antioxidant cocktail .this group will be for comparison with 1st group. after starting this antioxidant cocktail we will see hemoglobin of pt at regular interval of 3 months and follow up this for 1 year and then compare this with those thalassemia pt in which antioxidant was not given
purpose of this trial is to reduce blood transfusion frequency in transfusion dependent thalassemic pts
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 1-18 years
- •Hb concentration 4–9g/L.
排除标准
- •Major congenital anamolies child will be excluded.
结局指标
主要结局
1.Hb level
时间窗: baseline | after 3 months | then at 6th month | then at 9th month | then finally after 1 year
2. Blood transfusion numbers in a year
时间窗: baseline | after 3 months | then at 6th month | then at 9th month | then finally after 1 year
3. changes in liver enzymes
时间窗: baseline | after 3 months | then at 6th month | then at 9th month | then finally after 1 year
次要结局
- changes in coagulation profile(baseline)
研究者
Dr Arti Purohit
Shyam shah medical college