OPEN LABEL SINGLE CENTRIC CLINICAL EXPLORATORY OF EFFICACY STUDY ON DIACARE CAPSULE, AN AYURVEDIC PROPRIETARY FORMULATION

Background of the study: Type II Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance, persistent hyperglycemia, and associated complications such as polyuria, polydipsia, polyphagia, and diabetic neuropathy. Conventional treatments include pharmacological agents like metformin, insulin, and SGLT-2 inhibitors, but these may have side effects and long-term dependency risks. Ayurveda offers a natural and holistic approach to diabetes management, focusing on herbal formulations that regulate blood glucose levels while minimizing complications. DIACARE CAPSULE, a proprietary Ayurvedic medicine, has been developed to support glycemic control and overall metabolic balance. The primary objective of this study was to clinically validate the efficacy of DIACARE CAPSULE in managing diabetes-related symptoms and improving glycemic control. The study aimed to assess its impact on blood glucose levels, metabolic health, and overall patient well-being. Methods: This Phase-II-A, single-center, open-label, therapeutic exploratory clinical trial was conducted on 20 patients diagnosed with T2DM. Participants were administered 1-2 DIACARE CAPSULES twice daily with lukewarm water for 30 days. Clinical and laboratory assessments were performed at baseline (day-1) and post-treatment (day-30). Ethical approval was obtained, and written informed consent was secured from all participants. Results: After 30 days of treatment: 80% (16 patients) experienced significant symptom improvement. 10% (2 patients) showed moderate improvement. 5% (1 patient) had mild improvement. 5% (1 patient) dropped out of the study. Laboratory investigations confirmed improvements in blood sugar levels and metabolic parameters. No severe adverse effects were reported. Conclusion: DIACARE CAPSULE demonstrated significant efficacy in managing diabetes-related symptoms and improving glycemic control. The findings support its potential as a safe and effective Ayurvedic intervention for T2DM. Further large-scale studies are recommended for validation.