Abstract

Background: Low back pain (LBP) is an increasing global health crisis associated with functional disability and widespread dependence on analgesic usage, such as non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, which carry long-term adverse side effects without a complete cure. The Ayurvedic therapeutics offer multi-target botanical and oleo-lipid formulations generally for pacifying vata and associated conditions. Objective: This clinical study evaluates the therapeutic efficacy and safety of a novel polyherbal topical formulation named AVN Ayurveda Back Care Oil by AVN Ayurveda formulations in managing non-specific musculoskeletal and inflammatory back pain. Methods: An open-label clinical trial was conducted on 30 outpatient subjects (aged 18 to 60 years) suffering from mild-to-severe muscular and inflammatory back pain devoid of structural deformities. Participants applied the oil topically for a duration of 2 weeks, preceded by a mandatory skin patch test. Primary outcome measures included the Numeric Rating Scale (NRS) for pain intensity and the Oswestry Disability Index (ODI) for functional limitations, assessed at baseline and post-intervention (Day 14). Appropriate parametric and non-parametric statistical tests were applied. Results: Out of 30 participants, 28 reported clinically meaningful pain reduction and functional recovery. Among the responders, 20 patients achieved highly significant relief, 6 demonstrated moderate improvement, and 2 experienced mild relief. Both NRS and ODI scores showed statistically significant reductions (p<0.001). Subgroup analyses revealed consistent efficacy across sexes and socioeconomic strata without adverse dermatological reactions. Conclusion: AVN Ayurveda Back Care Oil demonstrates substantial analgesic and anti-inflammatory efficacy, validating its potential as a safe, topical adjunct for non-specific back pain and justifying larger-scale randomised controlled trials.