AflaB2® and osteoarthritis: a multicentric, observational, post-marketing surveillance study in Indian patients suffering from knee osteoarthritis
Keywords:Aflapin®, Native collagen type II, AflaB2®, Osteoarthritis, Oral tolerization, 5-LOX
Background: Osteoarthritis (OA) is one of the most debilitating chronic degenerative joint disorder characterized by pain, inflammation and stiffness of joints with wear and tear of the cartilage. Recent evidences suggest the involvement of the immune pathway in OA development. This study was conducted to evaluate the efficacy and safety of AflaB2® capsules containing Aflapin® and native collagen type II in knee OA patients.
Methods: Total 40 knee OA subjects were enrolled at the out-patient department (OPD) of three different sites under supervision of physicians as per the inclusion and exclusion criteria of the study. Subjects were instructed to consume AflaB2® capsules once daily orally for three months. They were informed to visit the respective study center as per the schedule visits to assess and record the efficacy and safety.
Results: AflaB2® treatment showed significant reduction in pain and stiffness with improvement in physical functions compared to the baseline. The reduction in pain score was observed from 2nd visit on visual analogue scale (VAS). The VAS score was reduced to 1.63±1.23 (p<0.001) from its baseline score 6.0±1.04 at the end of the treatment. The WOMAC Total Score was reduced to 18.1±6.04 (p<0.001) from its baseline score 74.4±8.07 at the end of the treatment. The improvement was observed in WOMAC pain, stiffness and physical functions score. No significant side-effect was reported with AflaB2® treatment throughout the study.
Conclusions: The present study provides the evidence in support of the potential efficacy and excellent tolerability of oral intake of AflaB2® capsules in reducing OA symptoms.
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