Elastographic liver evaluation of Katukyadi churna in the management of Non-Alcoholic Steatohepatitis (NASH) – A single arm clinical trial.

Non Alcoholic Steatohepatitis (NASH) is the most severe histological form of non-alcoholic fatty liver disease (NAFLD). It progress to cirrhosis in 20% population and 40% will have death due to liver pathology. Still consensus on pharmacotherapy is yet to be evolved and till date there is no US FDA approved drug for NASH. Ayurveda formulation Katukyadi churna is explored in the possible management of NASH. Study is a single arm with pre and post test design. Sonologically diagnosed patients of fatty liver (n = 30) were screened. 11 patients meeting elastoghraphic criteria (6.4-11.7 kPa) were enrolled in the study. K. churna was administered in the dose of 6 g twice a day with water at the middle of the meal for a period of 6 months. Subjective parameters were Aruchi (Anorexia), Agnimandhya (loss of appetite), Ajeerna (indigestion), Gouravata. Follow up assessments were done on every 30th day. Study showed that K. churna produced significant improvement in various parameters. Significant decrease in weight, (p < 0.001), BMI (p < 0.001), Elastography (p = 0.001), total bilirubin (p = 0.02), Alanine Aminotransferase (ALT) (p < 0.001), Aspartate Aminotransferase (AST) (p = 0.001), Albumin (p = 0.04), Triglycerides (p = 0.005) were observed. Subjective symptoms like Ajeerna (p = 0.002), Agnimandhya (p = 0.004), Arochaka (p = 0.001), Gouvravata (p = 0.002) showed significant improvement. K. churna showed clinical significance in terms of improvement from pathological ranges to normative ranges in elastography, total bilirubin, AST, Albumin. K. churna reduced weight, BMI, hardness and stiffness of the liver, liver function derangements, triglycerides and improved other subjective clinical parameters. Drug has promising results in NASH and warrants further studies.