A POSITIVE CONTROLLED, RANDOMISED CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF LIVOMYN IN THE TREATMENT OF NAFLD

Objectives: To evaluate the clinical efficacy and safety of Livomyn in NAFLD. Material and Methods: A prospective, interventional clinical study was conducted on 300 patients of both sexes, aged between 18-65 years, confirmed with NAFLD from clinical examination, laboratory tests, ultrasound findings, and who were willing to give informed consent. All patients received Livomyn at a dose of 1tabletthrice daily for 8 weeks. All patients were evaluated at baseline and 8 weeks for biochemical investigations [hs-CRP, TNF-?, NF-?B, ALT, and AST (IU/L)]. Observation: Livomyn after 8 weeks, reduced inflammatory biomarkers including hs-CRP from 6211.8 ± 4238.2to 5119.2 ± 4668.2; TNF-? from 21.27 ± 5.94to 18.16 ± 4.95 (<0.001) and NF-?B from 2.28 ± 1.13to 1.82 ± 0.69. Further Livomyn reduced elevated liver enzymes including ALT from 29.19 ± 17.01to 22.90 ± 11.09(<0.001) and AST from 19.56 ± 10.52 to 22.90 ± 11.09(<0.001) after 8 weeks of treatment. Livomyn significantly reduced Fibrosis from 7.68 ± 2.66 to 6.82 ± 2.62(<0.001) and Steatosisfrom328.19 ± 32.45 to 310.92 ± 44.10. compared to the baseline. Similar reductions were also observed in the positive (Pioglitazone) controlled group. But none of the changes were significantly different between two groups. Result: Livomyn produced a significant reduction comparable to the positive (Pioglitazone) controlled drug, in all the inflammatory/metabolic parameters associated with NAFLD assessed after 8 weeks of treatment. No adverse events were reported by any patients. This indicates that Livomyn is clinically effective and safe for NAFLD.