NCT00809042已完成2 期
The Effect of Combination Therapy of Hydroxyurea With L- Carnitine and Magnesium Chloride on he-Matologic Parameters and Cardiac Function of β-Thalassemia Intermedia Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hematologic Parameters
研究概览
简要总结
The purpose of this study is determination of the efficacy of combination of hydroxyurea with L-carnitine or magnesium in improving hematologic parameters and cardiac status in patients with β-thalassemia intermedia in comparison with hydroxyurea alone .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 4 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Beta thalassemia intermedia patients with mean hemoglobin level >= 7gr/dl, need to blood transfusion with more than 6 months interval or no need to blood transfusion
排除标准
- •Hypothyroidism
- •Hypoparathyroidism
- •Diabetes mellitus
- •Hepatitis B and C
- •Positive tests for human immunodeficiency virus
- •Any cardiac symptoms or receiving drug for cardiac disease
- •Presence of other hemoglobinopathies except thalassemia intermedia and pregnant or lactating womens
研究组 & 干预措施
1
Experimental
Hydroxyurea
干预措施: hydroxyurea (Drug)
2
Active Comparator
L-carnitine and hydroxyurea
干预措施: L-carnitine and hydroxyurea (Drug)
4
Active Comparator
L-carnitine , magnesium chloride and hydroxyurea
干预措施: hydroxyurea,L-carnitine and magnesium chloride (Drug)
3
Active Comparator
magnesium chloride and hydroxyurea
干预措施: hydroxyurea and magnesium chloride (Drug)
结局指标
主要结局
Hematologic Parameters
时间窗: monthly
次要结局
- echocardiographic parameters(6 months)
研究者
研究点 (1)
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