Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CD(cluster of differentiation)4 and CD8 count
研究概览
简要总结
- Evaluate the therapeutic effects, health benefits, and immunological effect of Al-hijamah in children with beta thalassemia major.
- Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, in those patients.
详细描述
The present study will be carried on 60 children patients with β- thalassemia major attending The Hematology Unit of Paediatric Departments at Tanta University Hospital. Participants will divide into 3 groups:
Group 1: 20 patients receive Al-hijamah.
Group 2: 20 patients receive Al-hijamah plus iron chelation therapy.
Group 3: 20 patients receive iron chelation therapy only
Participants undergo:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children suffering from beta thalassemia major, with age range from 4-18 years.
排除标准
- •Children with Congenital heart disease
- •Children with Rheumatic heart disease
- •Presence of heart failure
- •Children with Coronary arterial disease
- •Children with Cardiomyopathy
- •Children with hypotension
- •Children with inflammatory skin diseases e.g. acute burns
研究组 & 干预措施
Group 1: ALhijama
20 patients under went Al-hijamah procedure for iron chelation
干预措施: Al-hijamah (Procedure)
Group 2: AL-hijama with deferasirox
20 patients receive deferasirox and Al-hijamah.
干预措施: Al-hijamah (Procedure)
Group 2: AL-hijama with deferasirox
20 patients receive deferasirox and Al-hijamah.
干预措施: Deferasirox (Drug)
Group 3:deferasirox
20 patients already receiving deferasirox
干预措施: Deferasirox (Drug)
结局指标
主要结局
CD(cluster of differentiation)4 and CD8 count
时间窗: 3month
count and percentage
次要结局
- serum levels of cholesterol and triglyceride(3month)
- alanine amino transferase , aspartate amino transferase(3month)
- serum ferritin(3 months)
- malodialdehyde ant total antioxidant capacity(3 months)