Efficacy of N-Acetylcysteine in Improving/Normalizing ALT & AST in Patients of NAFLD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change in Alanine transaminase,aspartate aminotransferase
研究概览
简要总结
Currently researches are focusing on the effect of antioxidants in the treatment of non-alcoholic fatty liver disease (NAFLD). Since N-acetyl cysteine (NAC) has been proven to have antioxidant and anti-inflammatory properties, therefore, we will conduct this study to determine the effect of NAC in patients of NAFLD with raised liver enzymes.
详细描述
The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing globally, and presents a challenge for the medical community since it has no FDA approved treatment. An important feature of non-alcoholic fatty liver disease (NAFLD) is hepatic steatosis leading to hepatic dysfunction . It has been reported that NAFLD patients with increased liver enzymes have a greater risk of developing complications like cirrhosis and end-stage liver disease. since N-acetyl cysteine (NAC) has been proven to have antioxidant and anti-inflammatory properties, therefore, we will conduct this study to determine the effect of NAC in patients of NAFLD with raised liver enzymes (ALT, AST). Patients presenting with ultrasound showing fatty liver with raised liver enzymes will be recruited. They will be randomized into two groups (group A and group B).
The odd number patients will be allocated group A and even number patients will be allocated to group B.
Group A: patients in this group will be advised to follow a diet plan & daily 20 minutes brisk walking.
Group B: Patients in this group will be given NAC 200mg BD along with diet plan & exercise. This drug will be provided to the patients by the investigators free of cost.
The liver function tests and side effects of NAC will be followed at 12 weeks .
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients of both genders between the ages of 20 years and 60 years, giving consent to be included in the study.
- •Patients having fatty liver on ultrasound with raised ALT and AST levels
排除标准
- •• Patients having other causes of steatosis eg, excessive alcohol consumption,
- •Patients taking steatogenic medications such as, methotrexate , corticosteroids etc.
- •Patients suffering from other diseases that could increase ALT levels eg. Viral hepatitis, HIV, autoimmune liver diseases, infiltrative liver diseases.
- •Patients suffering from malignancies.
- •Patients who are not compliant to the medicine.
- •Pregnant and nursing females
研究组 & 干预措施
DIET& EXERCISE
diet plan & daily 20 minutes brisk walking.
干预措施: Diet and exercise (Behavioral)
N Acetylcysteine WITH DIET & EXERCISE
NAC 200mg BD along with diet plan & exercise.
干预措施: Diet and exercise (Behavioral)
N Acetylcysteine WITH DIET & EXERCISE
NAC 200mg BD along with diet plan & exercise.
干预措施: NAC with diet and exercise (Drug)
结局指标
主要结局
Change in Alanine transaminase,aspartate aminotransferase
时间窗: 12 weeks
Change in Alanine transaminase,aspartate aminotransferase
次要结局
- Side Effects of NAC(12 weeks)
研究者
Tazeen Rasheed
Associate Professor
Dow University of Health Sciences