Fraxinus excelsior and Vitamin E Combination for NAFLD (FEVEN)

Abstract

Objective: The combination of Vitamin E 400 IU soft gelatin capsule and Fraxinus excelsior 500 mg soft gelatin capsules (Ensules+) were evaluated for safety and efficacy as compared to Vitamin E 400 IU soft gelatin capsules in patients with NAFLD. Material and Methods: The prospective, open-label, comparative, randomized, single centre clinical trial was conducted by Macleods Pharmaceuticals in collaboration with Muktai Hospital, Nashik. Total of 24 NAFLD patients were divided into 2 groups and received either Vitamin E (400 IU) soft gelatin capsule or Ensules+ (combination of Vitamin E 400 IU and Fraxinus excelsior 500mg) soft gelatin capsules BID for 8 weeks. The Grades of Liver steatosis after 8 weeks, liver function test (AST, ALT, ALP, bilirubin levels) and serum lipid profile (Tg, Tc, HDL, LDL) was evaluated at the end of the study. Result: Nonalcoholic fatty liver disease (NAFLD) patients with Vitamin E and Ensules+ therapy BID for 8 weeks revealed no significant difference in the physical parameters like mean body temperature, pulse rate and blood pressure from baseline to end of the study. Significant improvement in lipid profile and liver function parameters were observed in both the groups at the end of the study as compared to the baseline. The % improvement in Tc and LDL (3.27 % and 4.93% respectively) from baseline were significant in Ensules+ group (B) as compared to Vitamin E group (A) (1.10% and 1.13 % respectively), also HDL levels were significantly elevated (1.34 %) in Ensules+ group. Percentage improvement in liver function parameters in group A patients treated with Ensules+ Capsule had higher AST (53.64%), ALT (59.53%) ALP (38.43%) and Bilirubin levels (56.54%) as compared to group B patients treated with vitamin E capsules. 5 Patients treated with Ensules+ (combination of Vitamin E 400IU and Fraxinus excelsior 500mg) soft gelatin capsules) showed significant regression with the fatty liver disease at the end of the study. Conclusion: Combination of Vitamin E and Fraxinus excelsior (Ensules+) capsule were found to be better in improving the lipid profile and liver function parameters in patients with NAFLD. To the best of our knowledge, this is the first study which compares the combination with Vitamin E capsule and found to be more effective in treating patients with NAFLD.