Randomized open label comparative clinical study to assess the efficacy of Ghati Yantra Raktamokshana with Lauha Shalaka Agnikarma in pain management of Gridhrasi

Abstract

Randomized Open-Label Comparative Clinical Study to Assess the Efficacy of Ghati Yantra Raktamokshana with Lauha Shalaka Agnikarma in Pain Management of Gridhrasi newlineBackground: newlineGridhrasi (sciatica) is a common neuromuscular disorder characterized by radiating pain along the sciatic nerve pathway, often leading to disability and impaired quality of life. Conventional treatments offer symptomatic relief but are often associated with side effects or limited long-term efficacy. Ayurveda offers para-surgical modalities like Ghati Yantra Raktamokshana (vacuum-assisted bloodletting) and Lauha Shalaka Agnikarma (therapeutic heat cauterization), both mentioned for their efficacy in Vatavyadhi including Gridhrasi. However, comparative clinical evidence between these two therapies is limited. newlineObjectives: newlinePrimary Objective: newlineTo evaluate whether Ghati Yantra Raktamokshana is therapeutically equivalent to Lauha Shalaka Agnikarma in reducing pain levels in patients with Gridhrasi, as measured by the Visual Analog Scale (VAS). newlineSecondary Objective: newlineTo compare the incidence and severity of adverse events associated with Ghati Yantra Raktamokshana and Lauha Shalaka Agnikarma in patients with Gridhrasi. newlineMethodology: newlineA randomized, open-label, parallel-group equivalence comparative clinical trial was conducted on 160 patients diagnosed with Gridhrasi. Participants were allocated into two groups (n=80 each): Group A received Ghati Yantra Raktamokshana once a week for three sessions, and Group B underwent Lauha Shalaka Agnikarma with the same frequency. Follow up was conducted on 22nd day. Visual Analog Scale (VAS), straight leg raising (SLR) and subjective parameters viz; Stambha (Stiffness), Suptata (Numbness), Spandana (Throbbing / Pulsating), Pada Gaurav (Heaviness) were assessed at baseline, after treatment on three settings weekly and on 22nd of follow-up. MRI and X-ray of the lumbosacral spine were used to classify underlying pathology (e.g., muscular vs discogenic origin).