Evaluation of efficacy of Hyponidd Tablet in comparison with Metformin: A Randomized Controlled Trial

Background: Diabetes mellitus (DM) is a major global health challenge, with India bearing one of the highest burdens. Conventional pharmacological therapies such as metformin remain the cornerstone of management but are limited by side effects and narrow focus on glycemic control. Ayurveda offers a holistic approach, integrating herbal formulations, diet, and lifestyle modification. This study evaluated the efficacy of a standardized Ayurvedic tablet compared with metformin in type 2 diabetes mellitus. Methods: A randomized, double-blind, active-controlled trial was conducted with 150 participants aged 30–70 years, HbA1c 7.0–10.0%, and BMI 20–40 kg/m². Participants were assigned to Arm A (Hyponidd tablets, 450 mg *2, BID) or Arm B (metformin, up to 1000 mg BID) for 12 weeks, with identical lifestyle counseling. Primary endpoint was change in HbA1c; secondary endpoints included fasting plasma glucose (FPG), postprandial glucose (PPG), anthropometrics, hypoglycemia incidence, quality of life. Results: 142 participants completed the study (72 in Arm A, 70 in Arm B). HbA1c reduction was greater in Arm A (–1.3%) compared to Arm B (–0.8%, p=0.02). FPG decreased by 38 mg/dL in Arm A versus 25 mg/dL in Arm B; PPG decreased by 62 mg/dL versus 40 mg/dL, respectively. More participants achieved HbA1c