Randomised Open Label Comparative Study Of Saroglitazar In Patients Of Non Alcoholic Fatty Liver Disease With Type 2 Diabetes Mellitus And Non Diabetic Population
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Liver Stiffness measurement score by Fibroscan
研究概览
简要总结
Aim: TO COMPARE THE EFFECT OF SAROGLITAZAR ON STEATOSIS AND FIBROSIS IN NON ALCOHOLIC FATTY LIVER DISEASE WITH TYPE 2 DIABETES MELLITUS AND NON DIABETIC POPULATION. Objective: To evaluate and compare the effect of Saroglitazar in patients of non alcoholic fatty liver disease with and without diabetes. Drug : Saroglitazar is the only drug approved by DCGI with permission Number: MF/SND/20/000376 dated 28-Dec-2020 to treat Non-Alcoholic Fatty Liver Disease (NAFLD) with associated co morbidities such as obesity, type 2 diabetes mellitus (DM), dyslipidemia, or, Metabolic Syndrome (MS), improves insulin sensitivity and lipid oxidation by acting on PPAR-γ and PPAR-α respectively. Patients of NAFLD will be divided among diabetic and non diabetic population. The patients of both the arms will be randomised separately into study and control group. The study group of both arm will receive saroglitazar 4mg for 6 months and the effect will be compared with the control group , and effect of sarogltazar will also be compared within diabetic and non diabetic population.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of fatty liver on ultrasound Patients with Type2DM Patients without diabetes.
排除标准
- •presence of chronic hepatitis B or C infection (positive Hbs Ag or anti HCV Ab) , significant alcohol intake (>20 gm/ day for males and >10 gm/day for females).
- •Cases with a history of intake of hepatotoxic drugs, drugs leading to hepatic fibrosis or drugs supposed to decrease hepatic fibrosis ( obeticholic acid, vitamin E , pioglitazone, UDCA, omega fatty acid ) , documented cases of autoimmune hepatitis, hepatic storage disorders such as hemochromatosis and Wilson’s disease will be excluded.
- •Patients having others co-morbidities like hypothyroidism, ischemic heart disease or chronic kidney disease will not be included.
- •Pregnant patient will not be included.
结局指标
主要结局
Liver Stiffness measurement score by Fibroscan
时间窗: once before initition of drug and once after completion of 6 months course of drug
次要结局
- SGOT(SGPT)
研究者
Dr ARSH GUPTA
IMS and SUM hospital