An Open Labelled Active controlled Randomized Comparative Clinical Trial to Evaluate the Adjuvant Effect of Niruryadi Gulika in the Management of Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus is a major global and national health concern, with India bearing a significant disease burden. In Ayurveda, the condition can be correlated with Prameha, which is described as a chronic metabolic disorder with multifactorial etiology. Despite the availability of conventional antidiabetic drugs such as Metformin and Glimepiride, long-term therapy is often associated with adverse effects, limited metabolic correction, and reduced patient compliance. Hence, there is a growing need to evaluate safe and effective adjuvant therapies.Niruryadi Gulika is a ayurvedic formulation traditionally indicated in the management of Prameha. Experimental studies have demonstrated its antidiabetic, antioxidant, and anti-inflammatory potential; however, systematic clinical evaluation in human subjects is limited.The present study is an open-label, randomized, active-controlled comparative clinical trial designed to evaluate the adjuvant effect of Niruryadi Gulika  along with standard antidiabetic therapy (Metformin and Glimepiride) in patients with Type 2 Diabetes Mellitus. A total of 60 eligible patients will be randomly allocated into two groups: the trial group receiving Niruryadi Gulika in addition to standard treatment, and the control group receiving standard treatment alone, for a duration of 90 days.The efficacy of the intervention will be assessed using objective parameters such as fasting blood sugar, post prandial blood sugar, HbA1c, body weight, and BMI, along with subjective symptoms of Prameha. Safety and tolerability will also be monitored throughout the study. The study aims to generate clinical evidence regarding the role of Niruryadi Gulika as an effective and safe adjuvant therapy in the management of Type 2 Diabetes Mellitus.