Background: This 12-week study aimed to investigate the efficacy of the topical application of phytoconstituents derived from nine Indian medicinal plants by regulating the biomarker, 4-hydroxyproline protein, that stimulates the production of collagen in cartilage, in the treatment of knee osteoarthritis (OA), characterized by the gradual breakdown of the cartilage that cushions the joints, leading to pain, stiffness, reduced range of motion, limited mobility, and an increased proportion of obesity. Methods: A total of 144 patients with OA, verified by the Kellgren-Lawrence scale, were included, with 72 receiving topical phytotherapy (TPT) and 72 receiving nutraceutical supplements. At weeks 0 and 12, IL-10, TNF-alpha, malondialdehyde, creatine kinase-muscle, aldolase-A, and 4-hydroxyproline levels, pain-related outcomes, and anthropometric measurements have been assessed as per the approved protocol and kits for both groups. Results: The results showed that the TPT group had significantly reduced inflammation, oxidative stress, pain, and joint stiffness and improved cartilage formation compared to the control group. The areas under the ROC curves, risk ratios, and Kellgren-Lawrence scores of the studied risk factors in the TPT group were highly significant (p<0.0001) at week 12. Conclusion: These findings suggest topical phytotherapy for regulating the biomarker, 4-hydroxyproline, of collagen may have great potential in treating OA and provide a novel therapeutic approach for patients suffering from OA compared to the control group, as correlated with the KL scale. Key words: Osteoarthrosis; 4-hydroxyproline; Topical phytotherapy; ROC curves.
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