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Objectives: Osteoarthritis (OA) is characterized by progressive cartilage degradation and secondary inflammation of the synovial membrane. Studies have shown that mud therapy may influence serum levels of several cytokines involved in the pathogenesis of OA and chondrocyte metabolism. The main targets of our research were to make use of Lake Urmia mud for topical gel formulation, evaluation of the possible therapeutic effects of this gel on symptoms of patients with knee OA and the evaluation of serum tumor necrosis factor-α (TNF-α) level after mud therapy in comparison with the application of a placebo. Methods: Fifty (50) patients suffering from knee OA participated in this study and randomized into two groups: case group and control group. Patients in the case group received mud therapy and the placebo was applied to patients in the control group. Three (3) parameters including pain, morning stiffness, and joint functionality were assessed in all patients. Visual analogue scale and Western Ontario McMaster Osteoarthritis index (WOMAC) were the employed scales for pain assessment. Functional capacity was evaluated by using WOMAC functional capacity and WOMAC global index. All the mentioned steps were done before and after treatment. Blood samples, in both groups, were collected for measuring tumor necrosis factor (TNF)-α serum level. Results: All the differences (for three parameters), in the case group, were statistically significant. TNF-α serum level reduction in both groups were detected: 19.41% in the case group and 1.76% in the control group. Conclusions: Mud therapy using formulated gel is an effective method in knee OA treatment and pain reduction. Further studies may be needed for the evaluation of possible synergism between pharmacological treatment and mud therapy. [ABSTRACT FROM AUTHOR]