Evaluation of clinical efficacy and safety of RG-01 (Rumalaya gel) in management of chronic subacute inflammatory joint disorders

Pain is an inevitable part of chronic subacute inflammatory disorders and although there are many analgesics available for chronic mild intermittent joint pain; topical gel are often preferred; being effective, safe, convenient and economical. These topical gel contain counterirritants and rubefacients, which had been well studied in terms of its pharmacological properties. This study was planned to evaluate the efficacy and safety of the RG-01 (Rumalaya gel) in chronic subacute inflammatory joint disorders. Sixty-five ambulatory patients, of either sex were enrolled in the study and a written informed consent was obtained from all these patients. All included patients had clinical diagnosis of either of the following: Osteoarthroses, Polyarthritis, spondylosis, arthralgia, frozen shoulder, fibrofascitis, gout, neuralgia and low back pain over a period of 6 months prior to the study. Patients with established hypertension, renal, hepatic or cardiac failure, on longterm steroid treatment & suffering from autoimmune disorder; spastic condition or genetic disorders were excluded from the study. All patients were advised to apply Rumalaya ointment over the affected area, thrice daily for a period of 8-12 weeks. Statistical analysis of the observations was done according to intention-to-treat principles. Changes in various parameters from baseline values after the 5 month were evaluated by paired ‘t’ test. The minimum level of significance was fixed at 95% confidence limit and a 2-sided p value of less than 0.05 was considered significant. In patients with arthralgia, spondylosis and polyarthritis there was significant reduction in joint tenderness, joint swelling, mobility restriction and early morning joint stiffness, at the end of the study. In patients with osteoarthritis of knees, there was moderate reduction in joint tenderness, joint swelling, mobility restriction and early morning joint stiffness at the end of the study. In patients with low back pain though there was reduction in severity of pain, yet spinal mobility & early morning joint stiffness did not improve. In patients with sprains there was appreciable reduction in tenderness and improvement in joint mobility. There was good compliance to the treatment and there were no adverse events reported or observed in the study patients, during the entire period. INTRODUCTION It has been proposed that pain to be divided into two entities: “physiological” and “pathophysiological (clinical)”. “Physiological pain” describes the situation, in which a noxious stimulus activates peripheral nociceptors, which then transmit sensory information through several relays until it reaches the brain and is recognized as a potentially harmful stimulus. The pathophysiologic processes that occur after tissue injury result in a stimulusresponse pattern that is quite different from that seen after physiological pain and therefore has been termed “pathophysiologic pain”.