A Randomized Controlled Double Blind clinical trial to evaluate the efficacy of Vedanasthapana Mahakashaya as an anxiolytic and analgesic polyherbal drug in perioperative anorectal cases

Introduction: In surgery, pre-operatively anxiolytic drugs and analgesics are very essential for major or minor surgical procedures to better operative and post-operative outcomes. The Vedanasthapana mahakashaya, described by the Acharya Charaka, is a group of 10 herbs and those herbs are advocated as analgesic, and anxiolytic polyherbal composition by various text books of ayurveda. So, the aim of this study was to evaluate and compare the efficacy of the Vedanasthapana mahakashaya as an analgesic drug during post operative period and as an anxiolytic drug for pre operative anxiety. Metarials & Methods: The study was a prospective, randomized, double blind, controlled trial. 80 patients of anorectal diseases who undergone for surgical intervention were randomly allocated in one of two groups. Group-1 received Vedanasthapana mahakashaya kwath (Decoction), 30ml orally in preoperative and postoperative period while group-2 was treated with Tab. Alprazolam 0.25mg pre-operatively and Tab. Paracetamol 500 mg postoperatively. Anxiety was assessed on the basis of Anxiety score of Hospital Anxiety and Depression Scale (HADS) preoperatively and analgesia was assessed postoperatively by internationally validated Visual Analogue Scale. Inj. Diclofenac sodium 75mg IM was administered as a rescue analgesic. Results: Pain-baseline pain scores were not statistically differed in both groups. Both the groups showed statistically significant reduction in pain at the end of trial period. Both were found to be significantly similar (P 0.4856) but group-1 showed more reduction in pain 84.72% (P<0.0001) than the group-2 which have 80.08% reduction in VAS score (P<0.0001) Anxiety- The values of both the groups were showing statistically significant difference at different observational intervals but the reduction was significantly higher in group-2 (P<0.0158). Conclusion: Administration of the Vedanasthapana mahakashaya decoction is effective for post operative pain relief but less effective for preoperative anxiety.