Abstract
Introduction: Body pain disorders like knee pain, low back pain and primary headache disorders impose burdens that include substantial personal suffering, impaired quality of life, and financial cost. Repeated attacks, and often fear of future attacks, affects the family life, social life, and employment. Objectives: To evaluate the Safety, Efficacy and tolerability of four types of Amrutanjan Pain Balm preparations for rapid pain relief in patients with primary type of headache and body pain disorders. Materials & Methods: This study is a randomized, multicentric, open label, interventional study conducted at a secondary care centre in Vellore. A total of 150 patients were screened and 144 patients were enrolled who were diagnosed with either body pain disorders like knee pain, low back pain or primary type of headache disorders like migraine, tension type headache and other primary head ache disorders. All the study participants were randomized to four arms of 36 each such that each arm comprised of 12 patients with knee pain, 12 patients with low back pain and 12 patients with primary headache disorder to receive four different formulations of Amrutanjan pain balms. Efficacy was evaluated by assessing pain reduction after treatment at various time points and duration of action. Visual analogue scale questionnaires were used post study to obtain feedback on overall status of improvement. Results: Patients enrolled with headache had 75 % tension-type, 17% migraine and 8% Cluster headache; those with knee joint Pain had osteoarthritis (80%) and reactive arthritis (20%) whereas patients with low back pain had lumbar strain and lumbar spondylosis. The onset of action was 55 seconds for patients with headache disorders, while it ranged between 95 to 115 seconds for joint pain and low back pain respectively. Highly significant improvement in the VAS score, was observed after 5, 10 and 30 minutes of test product application. Conclusion: All the four types of topical Amrutanjan balms were found to be effective and safe for the treatment of primary headache and body pain disorders.