NCT05584956招募中3 期
Clinical Study to Evaluate the Possible Efficacy and Safety of L- Carnitine and Sildenafil in Children Having Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Cardiopulmonary functions
研究概览
简要总结
This study aims to investigate the possible efficacy and safety of L_Carnitine and Sildenafil on patient with Beta thalassemia complicated with increased Tricuspid Regurgitant Jet Velocity
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
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with Beta thalassemia major who have increased TRJV more than 2.5m/s.
- •Children age from 6-18 years
排除标准
- •Others hemolytic anemia
- •Young age before 6 years of age
- •Allergy to Sildenafil or L-carnitine
- •Patient with documented causes of pulmonary hypertension rather than caused by Beta thalassemia.
- •Hepatic dysfunction: serum Alanine Aminotransferase (ALT) 3X.
- •Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
研究组 & 干预措施
Group 1
Active Comparator
n=22): Patients will receive traditional treatment and L- carnitine 50mg/kg/day orally (maximum dose 3g per day)
干预措施: L_carnitine (Drug)
Group 2
Active Comparator
n=22): Patients will receive traditional treatment and Sildenafil 0.25mg/kg/dose every 6 h orally (maximum dose 60 mg per day)
干预措施: Sildenafil (Drug)
结局指标
主要结局
Cardiopulmonary functions
时间窗: 3 months
change in the studied cardiopulmonary functions at the baseline and 3 months after intervention
次要结局
- Biochemical parameters(3 months)
研究者
Mostafa Zaki Zedan
Clinical pharmacist
Tanta University
研究点 (1)
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