Evaluation of Efficacy of Phalatrikadi Ghan Vati in Patients of Non-Alcoholic Fatty Liver Disease through Reverse Pharmacology Approach – Study Protocol

Abstract

Background: Non-alcoholic fatty liver disease (NAFLD), mostly diagnosed incidentally, is a rapidly emerging liver disorder. In absence of any specific treatment, current management focuses on theuse of hepatoprotective agents in addition to lifestyle modification and prevention of metabolic syndrome. Several Ayurveda agents have shown promising effects in patients over centuries of use. But this evidence needs to be assessed scientifically through reverse pharmacology approach. A polyingredient Ayurveda drug, Phalatrikadighanvati (PGV) has been selected for this study because of its long history of use and that its individual contents have shown positive results in liver disorders. Objective: Evaluation of efficacy of Phalatrikadighanvati in patients of non alcoholic fatty liver disease (NAFLD) along with its pharmaceutical and analytical study. Materials and Methods: The drug shall bepharmaceutically processed and analyzed as per pharmacopoeial standards.Present study has been designed as a randomized placebo controlled double blind clinical trial in two stages. The first stage shall be a pilot study to decide the best effective and safe dose in patients of NAFLD. The pilot study shall include two groups of 10 patients each in a dose of PGV 500mg and 1gm respectively twice a day for 12 weeks. After theselection of thebest dose, RCT will be conducted on that dose in the second stage.It shall be a Phase 2 trial with 60 patients divided equally in two groups.The patients in group one shall be given a dose as per the outcome of the pilot study twice a day and another group shall be administered placebo for a period of 12 weeks. Results: Efficacy of Phalatrikadi ghan vati will evaluated in terms of subjective and objective parameters using paired and unpaired t-test. Conclusion: PGV is expected to improve the diagnostic parameters in patients of NAFLD thus proving to be efficacious in managing NAFLDand act as a potent hepatoprotective agent.