EFFICACY OF PRAMEHAGAJAKESARI RASA AND NYAGRODHADI CHURNA AS ADD-ON THERAPY IN TYPE 2 DIABETES MELLITUS WITH POOR GLYCAEMIC CONTROL: AN OPEN-LABEL SINGLE-ARM CLINICAL TRIAL

Abstract

Background: Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder in which inadequate glycaemic control remains a clinical challenge. Ayurveda describes Madhumeha within Prameha and provides medicinal and lifestyle approaches for its management. Methods: An open-label, prospective, single-arm clinical trial was conducted in patients with poorly controlled T2DM receiving oral hypoglycaemic agents. Participants received Pramehagajakesari Rasa 250 mg twice daily and Nyagrodhadi Churna 5 g twice daily before meals for 90 days as add-on therapy. Outcomes included HbA1c, fasting blood sugar (FBS), post-prandial blood sugar (PPBS), ten Madhumeha-related subjective parameters and diabetes-dependent quality of life assessed using ADDQoL-19. Objective parameters were analysed using paired t-test and subjective parameters using Friedman test. Results: Thirty-two participants were enrolled; 28 completed the study and 4 dropped out. Among completers, HbA1c decreased from 7.84 ± 0.55% to 7.21 ± 0.50% (8.04%; p=0.029), FBS from 146.20 ± 22.00 to 128.40 ± 20.00 mg/dL (12.18%; p=0.022), and PPBS from 224.50 ± 38.00 to 190.80 ± 34.00 mg/dL (15.01%; p=0.016). All ten subjective parameters improved significantly (p<0.05). ADDQoL-19 improved from -2.08 ± 0.42 to -1.64 ± 0.38 (21.15%; p=0.002). Conclusion: The combined add-on intervention was associated with improvement in glycaemic parameters, Madhumeha-related symptoms and diabetes-dependent quality of life. Because the study was single-arm and oral hypoglycaemic therapy was continued, the observed changes cannot be attributed independently to either Ayurvedic formulation. Controlled studies are required.