An Open label, phase II clinical study to evaluate the efficacy and safety of DPOR/JR2007 in osteoarthritis of knee

Abstract

AimTo evaluate the effect of DPOR/JR2007 in patients with moderate to severe knee osteoarthritis. MethodsForty-two subjects received DPOR/2007 (1400 mg) tablets twice a day over a 12-week period. Each tablet contained 7 standardised botanical ingredients i.e. Aristolochia indica, Balsamodendron mukul, Cassia tora, Hemidesmus indicus, Withania somnifera, Pterospermum acerifolium, and Vitex negundo. Primary efficacy variable was assessment of change in Q.1 (Pain while walking on flat surface) of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-Pain. Secondary efficacy variables consisted, change in Q.2 (Pain while going up and down the stairs) of WOMAC-Pain, WOMAC domains, Short Form-8 (SF-8) Quality of life (QoL) questionnaire, Global assessment of OA and use of rescue medication. Tumour Necrosis Factor - α (TNF-α) and Interleukin-6 (IL-6) serum levels were also measured in the study. ResultsThe mean (SD) Q.1 baseline scores of 3.5 (0.73) were significantly reduced to 2.5 (0.66) at the end of study period; p < 0.001. Similar mean reduction was reported for Q.2 and each of the WOMAC dimensions; p < 0.001 and the SF-8 scores also demonstrated significant improvement in subjects QoL; p < 0.001. For biomarker assessment, TNF-α was reduced in both sexes with significant decrease being observed in female subjects; p < 0.05. Analysis showed that serum IL-6 levels were increased in subjects but was not of clinical significance. Further, DPOR/JR2007 was well-tolerated with fewer adverse events, increased global assessment scores and minimum rescue medication usage. ConclusionDPOR/JR2007 supplementation was effective in relieving the pain and stiffness in patients with chronic knee OA and improvement was evident within 8–12 weeks. Future studies are warranted for understanding the exact mechanism of DPOR/JR2007 with respect to inflammatory cytokines.