Effect of N-acetylcysteine on cardiac iron status in transfusion dependent thalassemia children - A Randomized control trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
A randomized controlled trial study design will be used. Subjects will be defined as children aged 10 years-18 years of either gender with transfusion dependent beta-thalassemia diagnosis based on clinical phenotype and HPLC.
A feasibility sample of 60 patients with 30 patients in each group will be enrolled. The patients will be randomized in two groups using computer generated random number sequence. Allocation concealment will be done using serially numbered opaque sealed envelopes that will contain a paper slip with name of allocation group. The duration of study would be 1 year.
Demographic and clinical data will be recorded. Anthropometry and Clinical examination will be performed. Baseline hematologic investigations will be sent along with ECG, Echocardiography (In the department of cardiology at Lala shyam lal building) and cardiac MRI (to be done in PGIMS trauma centre as poor free on special request). No additional charges will be born by patient for any of these investigations.
Children in study group will receive tablet N -acetylcysteine at a dose of 10 mg/kg orally, once daily for six months, available in PGIMS central store as 600 mg tablet. This tablet is to be taken with food along with other medications.control group will not recieve n acetylcysteine will only recieve standard chelation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Children aged 10 to 18 years diagnosed with beta thalassemia( on regular transfusion for 1 year).
排除标准
- •Children with either of the following conditions will be excluded: 1.Children with documented renal and liver dysfunction/endocrine/ cardiac dysfunction 2.Receiving any supplementation (other than folic acid) within the past one month 3.Child on any cardioprotective drugs 4.Known hypersensitivity to N-acetylcysteine 5.Refusal of consent by parent/guardian.
研究者
Dr Alka Yadav
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak HARYAN
