Clinical Evaluation of Vedistry Shallaki + Tablets in the Management of Osteoarthritis

Objective: To establish the efficacy and safety of Vedistry Shallaki + Tablet in the management of osteoarthritis (OA). Method: A randomized, double blind, active controlled, single center, clinical study was carried out in 300 osteoarthritic subjects to evaluate the efficacy and safety of Vedistry Shallaki + Tablet in relieving symptoms of moderate to mild OA. The efficacy and safety of Vedistry Shallaki + Tablet administration in a dose of 1 tablet twice daily for 90 days was directly compared with the selective COX-2 inhibitor, celecoxib given in a dose of 100 mg twice daily using total Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score, pain score, functional ability score, visual analog scale (VAS) score and Lequesne functional index values. Results: The results of the study showed that Vedistry Shallaki + Tablet can provide significant improvement in relieving the symptoms and the pain associated with OA. Osteoarthritic subjects receiving Shallaki Plus reported statistically significant changes/decreases in their clinical symptoms and pain compared to those receiving Celecoxib. This was evident from significant changes in the total Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score, pain score, functional ability score, visual analog scale (VAS) score and Lequesne functional index values at P < 0.05 level. Conclusion: Vedistry Shallaki + Tablet promises the beneficial effects for the treatment of osteoarthritis by controlling inflammatory responses as well as the pain without any adverse effects.