Efficacy of thalidomide in transfusion dependent thalassemia: a randomized double blind placebo controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of blood transfusions required after thalidomide intervention
研究概览
简要总结
This shall be a randomized double blind placebo controlled trial on patients with diagnosis of transfusion dependent thalassemia, 12 to 25 years of both genders registered in the Thalassemia Unit of the Department of Pediatrics, IMS, BHU. Patients would be randomized to receive either thalidomide or placebo. Randomization would be done by computer generated computerized tables. Baseline work up would be done and patients would be entered in the trial after written informed consent. They would be followed up regularly to see their requirement of blood transfusions during 6 months. At the end of 6 months, investigations would be repeated and the requirement of blood transfusions would be calculated to see the effect of thalidomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both genders would be selected Transfusion dependent Homozygous beta thalassemia HbE beta thalassemia Hydroxy urea refractory.
排除标准
- •Pregnant/planning pregnancy/lactating females Hepatitis B,C and HIV positive patients Patients with renal, cardiac, liver disease History of cerebrovascular accidents Splenectomized patients.
结局指标
主要结局
Number of blood transfusions required after thalidomide intervention
时间窗: baseline, 3 months, 6 months
次要结局
- Rate of fall of hemoglobin(Change in RBC indices)
研究者
Vineeta Gupta
Department of Pediatrics, Institute of Medical Sciences, BHU