Assessment of effective dose and tolerability of an herbal formulation Phalatrikadi Ghana Vati in patients of Non-Alcoholic Fatty Liver Disease through Dose Escalation

Background: Non-alcoholic fatty liver disease (NAFLD) is a rapidly growing public health concern with limited treatment options. Ayurveda offers plant-based remedies, which have been traditionally used since centuries but lack scientific evidence. The reverse pharmacology (RP) approach provides a framework for their scientific evaluation. This study aimed to determine the best effective and tolerable dose of Phalatrikadi Ghana Vati (PGV) for NAFLD management. Methods: A dose escalation study was conducted on 36 participants with NAFLD. Participants were randomly allocated to three groups receiving 500mg, 1000mg, or 1500mg of PGV twice daily for four weeks. Clinical symptoms (abdominal pain, nausea, indigestion), liver function tests (ALT, AST), and tolerability were assessed. Results: PGV significantly reduced abdominal pain (udarshula) compared to baseline, with the 1000mg dose showing the most significant improvement (p=0.002). Improvements in liver function tests were also observed, with the 1000mg dose again demonstrating the most significant reduction in ALT levels (p<0.01). PGV at 500mg and 1000mg was well-tolerated, but two patients in the 1500mg group reported mild gastrointestinal side effects. Discussion: This study suggests that PGV at a dose of 1000mg twice daily is safe, effective, and well-tolerated for managing NAFLD symptoms and improving liver function. The individual ingredients of PGV possess documented hepatoprotective properties, which may contribute to its therapeutic effect. Conclusion: RP offers a promising approach for evaluating Ayurvedic medicines. PGV at 1000mg twice daily demonstrates potential as a safe and effective treatment for NAFLD. Further research is needed to confirm these findings and explore the underlying mechanisms of action.