A 25-week Multicentric Prospective Open Labelled Trial Comparing the Safety and Efficacy of Saroglitazaar Magnesium 4mg with Dapagliflozin Propanediol Monohydrate 10mg along with Standard of Care in the Treatment of Metabolic Associated Steatotic Liver Disease.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To see the improvement in liver steatosis and liver fibrosis in response to Saroglitazaar Magnesium 4mg or Dapagliglozin propendiol Monohydrate 10mg
研究概览
简要总结
A 25-week multicentric prospective trial to compare the efficacy of Saroglitazaar Magnesium 4mg with Dapagliflozin Propendial Monohydrate 10mg along with the standard of care in persons with Metabolic Associated Steatotic Liver Disease. Persons with Grade 3 fatty liver or stage 2 liver fibrosis on Fibroscan will be put on either of the two drugs based on the discretion of the treating physician. The participants will be followed up for 6 months and repeat Fibroscan will be done . the response to the two drugs will be recorded and compared for safety and efficacy
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •A diagnosis of MASLD/NAFLD established by Vibration Controlled Transient Elastography using FIBROSCAN.
- •All persons with grade 3 fatty liver and F2 -F4 liver fibrosis on Fibroscan.
排除标准
- •Persons with known cirrhosis of liver persons with T1DM Persons taking alcohol in quantity more than allowed Persons already taking thiozolidedinediones, Vitamin E and SGLT2 inhibitors.
- •Persons taking alcohol in a quantity more than the standard limits set by aasld (Asia PACIFIC region) Persons having positive HBsAg and anti-HCV Persons with other causes of liver diseases e.g., Wilsons Disease, Autoimmune Disease, alcoholic liver disease Persons on steatogenic drugs like amiodarone, methotrexate, oral contraceptives, and glucocorticoids.
- •Pregnant and Lactating females Persons having underlying diseases like acute viral hepatitis, congestive hepatomegaly, or billiary congestion which can disturb the estimation done by fibro scan Persons having Hepatocellular Carcinoma Persons having known allergy to saroglitazaar magnesium Persons having any other severe illness that may render the follow-up visits difficult Persons not giving written consent for the study.
结局指标
主要结局
To see the improvement in liver steatosis and liver fibrosis in response to Saroglitazaar Magnesium 4mg or Dapagliglozin propendiol Monohydrate 10mg
时间窗: 6 months
次要结局
- To see the improvement in Liver Function Test(6 months)
研究者
Dr Dinesh Kumar
HARSHA CLINIC AND DIABETES CENTRE