Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis

124 patients with mild-to-moderate symptomatic knee osteoarthritis were randomized to daily treatment with tablets of either PG201, a 12-herb formulation, or SKI306X, a 3-herb formulation. The purpose of this study was to evaluate if PG201 demonstrated non-inferior efficacy and safety compared to SKI306X when assessed after 8 and 12 weeks. Efficacy parameters included a visual analog scale for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, the Euro Quality of Life 5 Dimensions questionnaire (EQ-5D), patient assessed symptom improvement, and rescue analgesia consumption. Adverse events and serious adverse events were monitored and documented. Results demonstrated no significant differences between groups in any efficacy or safety measure.