A prospective, randomized, controlled, open-label blinded end point clinical study of Ayulite in comparison with vitamin E for efficacy and safety in patients with non-alcoholic fatty liver disease

Abstract

Objective

The incidence of non-alcoholic fatty liver disease is increasing globally including India and the USA. Currently, vitamin E and pioglitazone are the only recommended drug treatments available. We aim to study the safety and efficacy of Ayulite a polyherbal capsule formulation containing combination of 11 herbs in patients with non-alcoholic fatty liver disease in comparison with Vitamin E.

Methods

Prospective, randomized, open-label blinded end point controlled clinical study for efficacy and safety of Ayulite in patients with non-alcoholic fatty liver disease (NAFLD) compared to Vitamin E supplements. Ultrasonography was used to grade fatty liver and vibration-controlled transient elastography was used to assess both the hepatic steatosis and fibrosis.

Results

A total of 67 patients were randomized (Ayulite group n = 33, vitamin E group n = 34), of which 61 patients were included for final analysis. Mean age of patients in the ayulite group and vitamin E group was 43.69 ± 9.89 years and 44.62 ± 10.42 years respectively with no other statistical difference in demographic characteristics between the groups. 4/29 in Ayulite [grade 1 fatty liver (n = 3), grade 2 (n = 1) and 7/32 patients in vitamin E (grade 1 fatty liver(n = 4), grade 2 fatty liver(n = 3)] completely recovered after 90 days of treatment with no statistical difference between the groups. Controlled Attenuation Parameter increased in Ayulite(p 0.002), decreased Ayulite (p NS). There were 8 and 10 adverse events were noted in ayulite and vitamin E group respectively.

Conclusion

The efficacy and safety of Ayulite was comparable to vitamin E which makes it a potential herbal option in the management of patients with grade 1 and 2 fatty liver.