Comparative study for efficacy of L-carnitine and N-acetyl cysteine on iron overload induced oxidative stress in patients with thalassemia: A Randomized Control Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference between N-Acetyl-Cysteine Vs L-Carnitine in the level of change in oxidative stress markers like MDA, GSH, SOD
研究概览
简要总结
Comparative study for efficacy of L-carnitine and N-acetyl cysteine on iron overload induced oxidative stress in patients with thalassemia: A Randomized Control Trial. Total of 100 patients of Transfusion Dependent Thalassemia on chelators will be randomized into three arms. In one arm (n=40), N-Acetyl- Cysteine 600 mg tablet will be given orally once a day for 6 months and in the second arm (n=40), L-Carnitine 1000 mg/day tablet orally will be given once in day for 6 months while in the third arm (n=20) placebo tablet will be given once a day for 6 months. Patients will be given standard of care of iron chelator, vitamin E and C, folate therapy. Primary outcome measurement is to calculate difference between NAC Vs LC in the level of change in oxidative stress markers like MDA, GSH, SOD.
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
- 5.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with thalassemia on blood transfusion 2)Patients or legally authorized representative willing to give informed consent and assent for the trial.
排除标准
- •Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition of N-Acetyl-Cysteine and L-Carnitine 2) Patients with history of central nervous system diseases (like epilepsy, psychiatric disorder) or taking any medicine for such illness.
- •Patients with history of severe renal or hepatic disease (like hepatitis B or C) 4) Patients with history of bronchospastic diseases (like asthma) 5) Patients with history of hypothyroid disorder 6) Patients on warfarin or acenocoumarin therapy.
结局指标
主要结局
Difference between N-Acetyl-Cysteine Vs L-Carnitine in the level of change in oxidative stress markers like MDA, GSH, SOD
时间窗: Two years
次要结局
- 1)Difference between N-Acetyl-Cysteine Vs L-Carnitine in liver enzymes, lipoproteins, cardiac biomarkers(-2) Number of ADRs in arms of N-Acetyl-Cysteine and L-Carnitine)
研究者
Dr. Pragna Roy
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh