Efficacy and Safety of Aflapin®, a Novel Boswellia Serrata Extract, in the Treatment of Osteoarthritis of the Knee: A Short-Term 30-Day Randomized, Double-Blind, Placebo-Controlled Clinical Study

医学 骨关节炎 沃马克 安慰剂 齿叶乳香树 可视模拟标度 内科学 随机对照试验 软骨寡聚基质蛋白 临床试验 胃肠病学 物理疗法 病理 替代医学
作者
Vasu Karlapudi,Krishna Bhagavan Sunkara,Purna Rajeswari Konda,Kadainti VS Sarma,Meher Prasanna Rokkam
出处
期刊:Journal of the American Nutrition Association 卷期号:42 (2): 159-168 被引量:14
标识
DOI:10.1080/07315724.2021.2014370
摘要

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-β-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.
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