Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- The change in the degree of steatosis in the Ultra Sound
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD) is a global public health concern, and the leading cause of chronic liver disease, especially in developed countries. NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. Lifestyle interventions, including dietary modification and exercise, remain the cornerstone of NAFLD treatment. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven NASH and fibrosis.
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)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography
排除标准
- •Pregnant and/or lactating women
- •Excessive alcohol use (defined as an average alcohol intake > 30 g per day in men and > 20 g per day in women)
- •Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis.
- •patients suffering from chronic kidney disease, and hyper/hypoparathyroidism
- •Hypersensitivity to carbocistiene.
研究组 & 干预措施
Control group
Patients will receive the standard conventional therapy in addition to placebo for 3 months.
干预措施: Physical activity, walking, and calorie restriction (Other)
Carbocistiene group
Patients will be given the standard conventional therapy plus carbocistiene 375 mg two times daily.
干预措施: Carbocysteine 375 MG (Drug)
Carbocistiene group
Patients will be given the standard conventional therapy plus carbocistiene 375 mg two times daily.
干预措施: Physical activity, walking, and calorie restriction (Other)
结局指标
主要结局
The change in the degree of steatosis in the Ultra Sound
时间窗: 3 months
The change in the degree of steatosis in the Ultra Sound
次要结局
未报告次要终点