Efficacy of rosuvastatin plus saroglitazar versus saroglitazar alone in patients of MASLD (ROSARO TRIAL)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare mean reduction in liver stiffness values after 24 weeks of intervention
研究概览
简要总结
Patients with advanced fibrosis defined by liver stiffness more than 8 Kpa to 20Kpa will be enrolled and randomised to either saroglitazar or combination of saroglitazar with rosuvastatin. Primary objective is to compare improvement in liver stiffness over 24 weeks. Secondary objective is to compare improvement in liver stiffness at 52 weeks. Also changes in lipid profile and other metabolic parameters will be compared at similar timeline. blood samples will be collected and evaluated for changes in cytokeratin-18 for studying changes in hepatic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults with MASLD with Liver stiffness 8 to 20 Spa.
排除标准
- •Hepatitis B or C, Significant alcohol intake, Patients on vitamin E or saroglitazar, Cirrhosis, malignancy,Pregnancy,lactation, uncontrolled diabetes, patients on statin for cardiovascular disease,Inability to perform fibroscan.
结局指标
主要结局
To compare mean reduction in liver stiffness values after 24 weeks of intervention
时间窗: To compare mean reduction in liver stiffness values after 24 weeks of intervention
次要结局
- To compare mean reduction in liver stiffness at 52 weeks, Proportion of patients achieving decrease in at least one grade of fibrosis, Mean reduction in steatosis measured by FibroScan, Mean improvement in AST, ALT, LDL, Triglyceride, HDL, VLDL, fasting blood sugar and HOMA IR at 24 weeks, Changes in cytokeratin-18 and TNF alpha at 24 and 52 weeks of intervention(24 weeks and 52 weeks)
研究者
Ajay kumar Mishra
SGPGI Lucknow