Evaluating the Safety and Efficacy of Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The change in the degree of steatosis in the ultrasound (US) is the primary endpoint.
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 (1). NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. NAFLD is characterized by excessive hepatic fat accumulation without other recognized causes of increased fat content (e.g., alcohol, virus, drugs, and autoimmunity). According to the Clinical Practice Guidelines of the European Association for the Study of the Liver, the diagnosis of NAFLD requires the exclusion of daily alcohol consumption >30 g for men and >20 g for women
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 60 Years（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 (US).
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, and autoimmune hepatitis.
- •Patients suffering from chronic kidney disease, hyper/hypoparathyroidism. Hypersensitivity to erdostiene.
研究组 & 干预措施
Control group
25 patients received the standard conventional therapy in addition to placebo for 3 months.
干预措施: Standard Therapy (Other)
Erdosteine group
25 patients were given the standard conventional therapy plus erdostiene 300 mg two times daily.
干预措施: Standard Therapy (Other)
Erdosteine group
25 patients were given the standard conventional therapy plus erdostiene 300 mg two times daily.
干预措施: Erdosteine (Drug)
结局指标
主要结局
The change in the degree of steatosis in the ultrasound (US) is the primary endpoint.
时间窗: 3 months
The change in the degree of steatosis in the US is the primary endpoint.
The change in fibrosis risk scores
时间窗: 3 months
According to the Brunt criteria, fibrosis is classified in stages from stage 0 to stage 4.
次要结局
未报告次要终点