RESUMEN
BACKGROUND AND OBJECTIVE: Aflapin®, also known as AprèsFlex® was developed as an enhanced bioavailable extract of Boswellia serrata gum resin, standardized to 20% 3-O-acetyl-11-keto-ß-boswellic acid. This randomized, double-blind, placebo-controlled clinical trial confirms the efficacy of Aflapin in ameliorating the symptoms of osteoarthritis (OA) of the knee. METHODS: Based on the inclusion/exclusion criteria of the American College of Rheumatology, seventy subjects were recruited and randomized into Placebo (n = 35) and Aflapin (n = 35) groups. Subjects received either 100 mg Aflapin or a placebo for 30 days. All subjects were evaluated for pain and physical function using the standard tools i.e., Visual Analog Scale (VAS), Lequesne Functional Index (LFI), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the baseline (Day 0), 5, and 30 days of treatment. Additionally, several inflammatory and cartilage biomarkers, including matrix metalloproteinase-3 (MMP-3), tumor necrosis factor-α (TNFα), high-sensitive C-reactive protein (hsCRP), Cartilage Oligomeric Matrix Protein (COMP), and collagen type II cleavage (C2C) were evaluated. Total blood chemistry analyses were conducted to affirm the safety of Aflapin. RESULTS: Sixty-seven subjects completed the study. Aflapin conferred significant improvements in pain scores as early as five days of treatment. Post-trial, VAS, LFI, WOMAC pain, WOMAC stiffness, WOMAC function, and total WOMAC scores decreased in the Aflapin group by 45%, 40.9%, 44.4%, 66.3%, 44.4%, and 48%, respectively. Aflapin supplementation also reduced circulating MMP-3, TNFα, hsCRP, and C2C. CONCLUSION: This investigation affirms that Aflapin is clinically efficacious, fast-acting, and safe in the management of osteoarthritis. No significant adverse effects were observed.