ArticleJournal of Ayurveda and integrative medicine
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.
Article in Journal of Ayurveda and integrative medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveThe 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.
methodsProspective, 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.
resultsA 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.
conclusionThe 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.
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