Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior histological evidence of steatosis or steatohepatitis admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent will be included in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
RECRUITINGReduction in Hepatic Venous Pressure Gradient in the two groups from baseline.
Time frame: 1 year
Improvement in liver function test as compared to baseline.
Improvement is defined as Serum bilirubin,AST,ALT,serum Albumin within normal limits
Time frame: 1 year
Improvement in Liver Stiffness Measurement as compared to baseline.
LSM \< 10 Kpa
Time frame: 1 year
Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR)
HOMA IR \<2.5
Time frame: 1 year
Incidence of new onset upper gastrointestinal bleed in both groups
Time frame: 1 year
development of new onset of ascites in both groups.
Time frame: 1 year
Number of Spontaneous Bacterial peritonitis cases in both groups.
Time frame: 1 year
ACLF (Acute on Chronic Liver failure) cases in both groups.
Time frame: 1 year
Reduction in hepatic and systemic inflammatory markers like TNF-α in both groups
Time frame: 1 year
Reduction in hepatic and systemic inflammatory markers like C Reactive Protein in both groups
Time frame: 1 year
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Reduction in hepatic and systemic inflammatory markers like serum endotoxins in both groups.
Time frame: 1 year
Histological and permeability changes in the duodenal biopsy in both groups.
Time frame: 1 year