Research Question:~Compare the efficacy & safety of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA alone versus Placebo among Compensated chronic liver diseased patients~Primary Objective:~To assess the efficacy of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA 250mg alone and versus Placebo in the reduction of total serum bilirubin, Direct serum bilirubin and elevated liver Enzymes from baseline to End of Treatment (EOT)~Secondary Objectives:~To assess the efficacy of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA 250 mg alone and versus Placebo in reducing the degree of steatosis as measured by Vibration-controlled transient elastography with Controlled Attenuation Parameter (CAP)~To assess the safety of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA 250 mg alone and versus Placebo among compensated Chronic Liver Diseased Patients~To describe improvement in quality of life for patients after treatment~A study population of 297 patients suffering from compensated chronic Liver Disease, who will be randomized according to Vibration-controlled transient elastography in screening visit into 2 groups:~Group 1: with non-cirrhosis, F0, F1 and F2.~Group 2: with advanced fibrosis and cirrhosis, F3 and F4.~Each group will receive either Ursoplus® capsules (UDCA 250mg & Silymarin 140mg), or UDCA alone or Placebo, through Stratified random sampling.~Duration for enrollment: 6 months Total duration of the study/subject will be approximately: 6 months for treatment and follow-up visits including the screening visit~Subjects will be enrolled for a duration of 6 months including the screening visit~Screening visit 1 (Treatment initiation)~Visit 2: after 1st month, follow-up 1~Visit 3: after 2nd month, follow-up 2~Visit 4: after 3rd month, follow-up 3~Visit 5: after 4th month, follow-up 4~Visit 6: after 5th month, follow-up 5~End of Study visit, after 6th month of treatment, follow-up 6
This study aims to compare the efficacy & safety of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA alone versus Placebo among Compensated Chronic Liver Diseased Patients