A CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ORAL THERAPY WITH SALLAKI MR AND SALLAKI PLUS TABLET (SEQUENTIAL THERAPY) ALONG WITH TOPICAL APPLICATION OF SALLAKI LINIMENT IN PATIENTS WITH ACUTE MUSCULOSKELETAL SPASM WITH LOW BACKACHE

Abstract

Low back pain is a common problem affecting the major population in the world. Muscular spasms are often seen in association with low back ache. There may be many different reasons for back ache and subsequent spasm. Because there is great variability and inconsistency in the management of this condition, it warrants a simple yet powerful solution. This clinical study was planned to evaluate the efficacy of the Herbal formulations namely Tablet Sallaki MR along with Sallaki plus (Sequential therapy) and Sallaki Liniment, in patients of Acute Musculoskeletal Spasm associated with Low Backache. The trial was conducted at I.P.G.T and R.A., Gujarat Ayurved University, Jamnagar in the Department of Panchakarma under TRC (Technical Research Committee) project. This was an open label, interventional, single centre and non-comparative study. The treatment was done for one group consisting of 60 patients diagnosed with lower back pain and musculoskeletal spasm, prospectively, for knowing its safety and efficacy. Tab Sallaki MR was given for 7 days followed by Tab Sallaki Plus for 14 days. This was followed by Sallaki liniment application for 14 more days. In this study statistically highly significant results were obtained in patients of low Backache associated with musculoskeletal spasm. In efficacy parameters the relief was 48.23% in Low Backache, 66.92% in pain on Visual Analogue Scale and 61.15% in MOD Questionnaire. Almost 67% showed mild improvement with no complaints of any major side effect.