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

Author(s):  
Piyush Chaudhary ◽  
Bharat Rathi ◽  
Renu Rathi ◽  
Vidushi Tyagi

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.

2015 ◽  
Vol 24 (2) ◽  
pp. 197-201 ◽  
Author(s):  
Ramesh P. Arasaradnam ◽  
Michael McFarlane ◽  
Emma Daulton ◽  
Erik Westenbrink ◽  
Nicola O’Connell ◽  
...  

Background & Aims: Non-Alcoholic Fatty Liver Disease (NAFLD) is the commonest cause of chronic liver disease in the western world. Current diagnostic methods including Fibroscan have limitations, thus there is a need for more robust non-invasive screening methods. The gut microbiome is altered in several gastrointestinal and hepatic disorders resulting in altered, unique gut fermentation patterns, detectable by analysis of volatile organic compounds (VOCs) in urine, breath and faeces. We performed a proof of principle pilot study to determine if progressive fatty liver disease produced an altered urinary VOC pattern; specifically NAFLD and Non-Alcoholic Steatohepatitis (NASH).Methods: 34 patients were recruited: 8 NASH cirrhotics (NASH-C); 7 non-cirrhotic NASH; 4 NAFLD and 15 controls. Urine was collected and stored frozen. For assay, the samples were defrosted and aliquoted into vials, which were heated to 40±0.1°C and the headspace analyzed by FAIMS (Field Asymmetric Ion Mobility Spectroscopy). A previously used data processing pipeline employing a Random Forrest classification algorithm and using a 10 fold cross validation method was applied.Results: Urinary VOC results demonstrated sensitivity of 0.58 (0.33 - 0.88), but specificity of 0.93 (0.68 - 1.00) and an Area Under Curve (AUC) 0.73 (0.55 -0.90) to distinguish between liver disease and controls. However, NASH/NASH-C was separated from the NAFLD/controls with a sensitivity of 0.73 (0.45 - 0.92), specificity of 0.79 (0.54 - 0.94) and AUC of 0.79 (0.64 - 0.95), respectively.Conclusions: This pilot study suggests that urinary VOCs detection may offer the potential for early non-invasive characterisation of liver disease using 'smell prints' to distinguish between NASH and NAFLD.


2017 ◽  
Vol 23 (10) ◽  
pp. 1881 ◽  
Author(s):  
Shira Zelber-Sagi ◽  
Shiran Bord ◽  
Gali Dror-Lavi ◽  
Matthew Lee Smith ◽  
Samuel D Towne Jr ◽  
...  

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