A Prospective Randomized Comparative intervention Study of Efficacy and Safety of Saroglitazar and Vitamin E in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH) - SVI

Bilal Ahmad Mir0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

研究概览

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•Inclusion Criteria
•1. Confirmed Diagnosis of NAFLD established either by imaging or liver biopsy according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasaniet al.2017).
•2.Adults ( >18years)

•Exclusion Criteria
•1.Absence of regular or excessive use of alcohol within 2 years prior to initial screening.
•2.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis.
•3.Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or Imaging techniques.
•4.Patients with Hypothyroidism and celiac disease.
•5. Presence of alternative causes of fatty liver, including:
•Weight loss >10% in the 6 months before the Screening Visit
•Total parenteral nutrition, starvation or protein-calorie malnutrition
•Use of drugs associated with NAFLD.
•6. History of malignancy in the past 5 years and/or active neoplasm
•7. Pregnant/lactating female
•8. History of bladder disease and/or haematuria or has current haematuria.

发起方

Bilal Ahmad Mir