Effectivity of Silymarin in improving hepatic fibrosis among patients with non alcoholic fatty liver disease – placebo controlled RCT

INTERVENTION: Place of study: Medicine Out Patient Department, Chittagong Medical College Hospital, Chittagong, Bangladesh Patients who meet up inclusion and exclusions criteria will be informed in details about the study. Such 80 patients will be finally included in the study. Written informed consent in Bengali for inclusion in the trial will be obtained from all study subjects. The potential risks and benefits of the use of the drug will be explained to them. All patients who have given consent will do baseline SGPT (ALT), SGOT(AST) and Fibroscan of Liver Consenting Patients will be divided into 2 groups using simple randomization. Interventional product: Cap Silybin 140mg (each capsule contains Silymarin 140mg, which is the dried extract of Milk Thistle Fruit). Group 1: Cap placebo (Capsule visually identical to Cap Silybin 140mg containing an inert substance), One(1) Capsule to be taken orally, twice(2) daily for one(1) year. Group 2: Cap Silybin 140mg, One(1) Capsule to be taken orally, twice(2) daily for one(1) year. All patients will get appropriate diet and lifestyle modification advice. All patients will get appropriate treatment for comorbid diseases such as HTN, IHD, DM, Dyslipidemia or Hypothyroidism if any one or more are present, according to standard guidelines and protocols. CONDITION: Nonalcoholic Fatty Liver Disease PRIMARY OUTCOME: Decrease in Fibroscan score of Liver (Kpa) [After 1(one) year of treatment]; Decrease in SGOT (IU/L) [ After 1(one) year of treatment]; SECONDARY OUTCOME: SGOT/SGPT ratio [After 1(one) year of treatment]; INCLUSION CRITERIA: Fatty liver on ultrasonography of the hepatobilliary system ‐ Hepatocellular steatosis is the hallmark of NAFLD, and steatosis in more than 5% of hepatocytes is required for the diagnosis of NAFLD. Fatty liver is diagnosed based on the following ultrasound parameters; parenchymal brightness, increased echogenicity of the liver parenchyma in comparison to the corte Xof the right kidney, deep beam attenuation, bright vessel walls, and gallbladder wall definition.