Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- cluster of differentation4 and 8(CD4 and CD8)
研究概览
简要总结
Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.
详细描述
Study will be carried on children patients with β- thalassemia major attending The Hematology Unit of Pediatric Department at Tanta University Hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. Then Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.
Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of Nigella sativa in those patient.
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thalassemia with iron overload
排除标准
- •Thalassemia complicated with diabetes mellitus or hepatitis
- •Patients who discontinue treatment
研究组 & 干预措施
patients receiving Nigella
40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.
干预措施: nigella sativ (Drug)
结局指标
主要结局
cluster of differentation4 and 8(CD4 and CD8)
时间窗: 3 months
CD4 and CD8 cell per cmm
malondialdehyde
时间窗: 3 months
nmol serum level of malondialdehyde (nmol per liter)
total antioxidant
时间窗: 3 months
total antioxidant(mmol per liter)
次要结局
- total iron binding capacity(3 months)
- Serum iron(3 months)
- serum ferritin(3 months)
- complete blood count(3 months)