Comparison of the Safety and Efficacy of Newly-Developed Generic Ursodeoxycholic Acid (Cholicray^®) and Ursophar^® as Standard Drug in Patients with Non-alcoholic Fatty Liver Disease: A Phase IIa Double-Blind Randomized Controlled Clinical Trial

Abstract

Background: Ursodeoxycholic acid (UDCA) is a complementary treatment used to improve liver enzyme tests and reduce the risk of gallstone formation. Objectives: This study aimed to compare the safety and efficacy of two UDCA formulations: Cholicray® (a newly-developed generic drug, manufactured by Reyhaneh Pharmaceutical Co.) and Ursophar® (a standard drug, manufactured by Koushan Pharmed Co.), in patients with non-alcoholic fatty liver disease (NAFLD), which is one of the most prevalent chronic liver disorders. Methods: In this randomized, double-blind, phase IIa clinical trial, a total of 73 patients with ultrasound-confirmed grade II NAFLD who presented to Baqiyatallah Clinic were enrolled after obtaining informed consent. Patients were randomly allocated in blocks to receive either Cholicray® or Ursophar®. By the end of the study, 55 patients (28 in the Cholicray® group and 27 in the Ursophar® group) completed the full 3-month treatment course and were included in the final analysis. Changes in liver enzymes, alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST), as well as any adverse events (dermatological, gastrointestinal, ocular, renal, pulmonary, neurological systems), were recorded and compared before and after treatment. Results: The findings indicated that both Cholicray® and Ursophar® reduced the levels of liver enzyme markers. The reduction in ALT levels was statistically significant in both groups (P = 0.001 and P = 0.004 for Ursophar® and Cholicray®, respectively). Additionally, there were no statistically significant differences in mean changes and adverse effects reported before and after treatment between the groups. Conclusions: The results of this study demonstrated that Cholicray®, similar to the standard treatment Ursophar®, has beneficial effects on liver enzyme biomarkers (LEBs) and does not induce significant adverse effects. However, our results are preliminary and require validation through larger, more comprehensive studies.