A Standardized Extract Improves Knee Joint Function and Cartilage Morphology in Human Volunteers with Mild to Moderate Osteoarthritis in a Randomized Placebo-Controlled Study.

Background And Objective: Roxb. ex Colebr. (Family: Burseraceae; Genus: Boswellia) gum resin (Salai guggul) has profound therapeutic value in Ayurvedic and Unani medicines in alleviating several chronic inflammatory illnesses, including arthritis, asthma, skin and blood diseases, fever, etc. SN13108F (Aflapin) is a proprietary, standardized gum resin extract. This 180-day randomized, placebo-controlled clinical study aimed to evaluate cartilage morphology using magnetic resonance imaging (MRI), pain and joint function and long-term safety in the SN13108F-supplemented volunteers with knee osteoarthritis (KOA).

Materials And Methods: Eighty adult male and female subjects with the Kellgren-Lawrence grade II - III KOA were supplemented with SN13108F (100 mg/day) or a matched placebo for 180 consecutive days.

Results: SN13108F reduced ( < 0.001; vs. baseline and placebo) Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, Lequesne's Functional Index scores, improved six-minute walk test, and stair climb test. Post-trial MRI assessments of the tibiofemoral joints revealed that the cartilage volume, thickness, and joint space width were increased ( < 0.001; vs. placebo), and levels of high-sensitivity C-reactive protein, matrix metalloproteinase-3, Fibulin-3, type II collagen degradation peptide in serum, and cross-linked C-terminal telopeptide of type II collagen in urine were significantly reduced ( < 0.001; vs. baseline and placebo) in the SN13108F-supplemented subjects. Hematology, complete serum biochemistry, urine analysis, and the participants' vital signs did not alter between the groups.

Conclusion: SN13108F supplementation is safe, and it mitigates joint pain and improves musculoskeletal function and cartilage morphology in KOA.