The Potential Role of N-Acetyl Cysteine or Alpha-Lipoic Acid as Adjuvant Therapies in the Treatment of Patients With Beta Thalassemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The change from baseline in carotid intima media thickness (CIMT)
研究概览
简要总结
The current study is to investigate the potential roles of N-acetyl cysteine and Alpha-lipoic acid in patients with beta-thalassemia.
详细描述
Beta-thalassemia (β-thalassemia) is a hereditary blood disorder, which is characterized by a genetic disorder in the production of β-globin chains. β-thalassemia is inherited mainly by an autosomal recessive manner resulting in reduced synthesis or absence of β-globin chains, leading to ineffective erythropoiesis and chronic hemolytic anemia. It is classified according to the severity into major, intermedia and minor.
This is a randomized, parallel, clinical study that will be conducted on sixty-six patients with beta-thalassemia. The study duration will be 12 weeks. Patients will be divided into three groups as follows:
Group I (n = 22):
This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only.
Group II (n = 22):
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with beta-thalassemia who will receive conventional thalassemia management.
- •Both genders.
- •Age ≥ 18 years old.
排除标准
- •Patients with familial hypercholesterolemia or history of premature atherosclerosis.
- •Patients with a prior history of significant cardiovascular diseases, such as coronary artery disease, myocardial infarction, or stroke.
- •Patients with severe renal dysfunction.
- •Patients with severe hepatic dysfunction.
- •Patients with diabetes.
- •Patients who will be non-compliant with the prescribed therapy.
- •Patients with other hemoglobinopathies.
- •Pregnant women.
- •Obese patients.
- •Patients who will receive antioxidant or anti-inflammatory medications.
- •Patients with inflammatory diseases, such as Systemic lupus erythematous, rheumatoid arthritis and inflammatory bowel disease.
- •Patients with oxidative stress related diseases, such as Alzheimer, Parkinson, COPD and cancer.
研究组 & 干预措施
Group 1: (Iron chelating agent group)
Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only.
干预措施: Iron chelating intervention (Drug)
Group 2: (Iron chelating agent + NAC group)
Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for 12 weeks.
干预措施: Iron chelating intervention (Drug)
Group 2: (Iron chelating agent + NAC group)
Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for 12 weeks.
干预措施: N Acetyl cysteine 600mg (Drug)
Group 3: (Iron chelating agent + ALA group)
Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for 12 weeks.
干预措施: Iron chelating intervention (Drug)
Group 3: (Iron chelating agent + ALA group)
Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for 12 weeks.
干预措施: Alpha Lipoic Acid 600 MG Oral Tablets (Drug)
结局指标
主要结局
The change from baseline in carotid intima media thickness (CIMT)
时间窗: 3 months
Non-invasive imaging technique, such as carotid ultrasonography will be used to measure carotid intima media thickness
次要结局
- Change in Malondialdehyde (MDA)(3 months)
- Change in high sensitivity C-reactive protein (hs-CRP)(3 months)
- Change in asymmetric dimethyl arginine (ADMA)(3 months)
- Change in lipid profile(3 months)
研究者
Mahmoud Mohamed Elkholy
Teaching Assistant
Tanta University