To assess the efficacy & safety of NILIN™ SR tablets in the management of osteoarthritis of knee

Abstract

To assess the efficacy & safety of Nilin™ SR tablets in the management of osteoarthritis of knee. 32 subjects from the age group 40-65 years having osteoarthritis of the knee, with no other rheumatologic condition were enrolled. Subjects were judged to have osteoarthritis with clinical diagnostic features; Knee pain for most days of the month, Morning stiffness of less than 30 minute duration, stiffness while resting the affected joint and age over 40 years. The primary outcome was self-reported pain, stiffness and physical function scores as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 6-minute walk distance and VAS scale measured at 0hr and 1, 2 and 4hrs respectively. Secondary outcomes included laboratory investigations and serological biomarker, i.e. Hs-CRP. A significant improvement in the clinical and biochemical endpoints along with excellent tolerability indicates that Nilin^TM SR can be used for the long term management of Osteoarthritis. Of the 32 subjects 30 subjects completed the study. Wilcoxon paired sample test indicated WOMAC Score significantly reduced from baseline to final visit for all the three parameters; Pain (P<0.0001) Stiffness (P<0.0001) and Physical disability (P<0.0001).A significant reduction was also noted in the visual analogue scale over the course of 4 hours after ingestion of medication. A significant improvement in the 6-minute walk distance (P < 0.05) and decrease in Hs-CRP levels was observed. No adverse events were reported in the trial.