Antidiabetic activity of Herbomineral formulation (GASY) in the management of Prameha with special reference to Type 2 Diabetes Mellitus- An experimental and pilot clinical study

Background: Diabetes Mellitus (DM) remains a significant global health challenge, with an increasing prevalence, particularly notable in India. Traditional Ayurvedic medicine offers potential alternative treatments for diabetes, often with fewer side effects compared to conventional methods. This study aimed to evaluate the antidiabetic activity of a herbomineral formulation GASY, which combines active ingredients like Gymnema sylvestre, Areca catechu, Shilajeet, and Yashada Bhasma. Materials and Methods: The research was structured into three phases. The first phase involved the pharmaceutical analysis and preparation of the GASY formulation. The second phase was an experimental preclinical study conducted on Wistar Albino rats, where the safety and efficacy of GASY was assessed through acute toxicity tests and efficacy evaluations in streptozotocin-induced diabetic rats. The third phase consisted of a pilot clinical trial involving diabetic patients to assess the formulation’s impact on human subjects. Results: In the preclinical phase, GASY at lower doses effectively reduced fasting blood sugar (FBS) levels without adverse effects. However, higher doses, while potent, led to hypoglycemia-related mortality. The clinical trial phase further confirmed the formulation’s efficacy, showing significant reductions in FBS and postprandial blood sugar levels. Additionally, serum insulin levels improved, and glycemic control was enhanced, as evidenced by reductions in HbA1c levels. Subjective assessments indicated marked improvements in diabetes-related symptoms, thereby enhancing patient quality of life. Conclusions: The findings indicate that GASY is a safe and effective adjunct treatment for diabetes. However, further research through larger, controlled studies is needed to fully validate its therapeutic potential and safety in individuals with type 2 diabetes