Clinical Benefits of Boswellia Serrata (BOSMAX®) in Early Knee Osteoarthritis: A Randomized,Placebo-Controlled,Double-Blind Study

Abstract

Osteoarthritis (OA) is a major cause of pain and reduced mobility in older adults, with few effective treatments currently available. This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Boswellia serrata extract (BOSMAX®), a botanical anti-inflammatory agent, in participants with non/mild OA. A total of 150 adults aged 40–75 were randomized to receive either BOSMAX® or a placebo daily for 90 days. Primary outcome measures included WOMAC scores, visual analog scale (VAS) for pain, and Lequesne Functional Index; secondary endpoints were SF-36 scores, tumor necrosis factor-alpha (TNF-α), and high-sensitivity C-reactive protein (hs-CRP). Significant improvements were observed in the BOSMAX® group compared with the placebo. The mean total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores decreased significantly at days 30 (−6.28), 60 (−15.24), and 90 (−24.55; P < .05). WOMAC sub-scores (pain, stiffness, and function) and VAS pain scores also showed significant reductions at days 60 and 90. Lequesne Index scores improved progressively (−1.37, −2.93, and −4.53 at days 30, 60, and 90, respectively; P < .05). TNF-α and hs-CRP levels decreased significantly (−104.75 ng/L and −5.67 ng/mL, respectively; P < .05) at day 90. However, no significant changes were observed in SF-36 scores. Both treatments exhibited good tolerability, with only one mild and unrelated adverse event reported. Vital signs, physical exams, and laboratory parameters remained clinically unchanged. BOSMAX® significantly improved knee-joint symptoms and inflammatory markers over 90 days in individuals with non/mild OA, supporting its potential as a safe therapeutic option.