Evaluation of Efficacy and Safety of Ayurvedic Formulation in Managing Madhumeha, Glycaemia, and Clinical Outcomes Secondary to Chronic Glycaemia

Objective:  Objective of this study is to assess the efficacy and safety of an Ayurvedic Formulation in improving the condition of Madhumeha by managing glycaemia and enhancing clinical outcomes related to chronic glycaemia. This will be an open label, two arm, prospective clinical study to evaluate efficacy and safety study having two dose groups of at least 25 subjects each.  After obtaining ethics committee approval and registering the study on the Clinical Trial Registry of India (CTRI), eligible participants aged 30–70 years as known cases of hyperglycaemia with or without OHAs will be screened and enrolled. There will be four visits per subject. On visit 1, subjects who consent to participate in the study will be screened based on inclusion-exclusion criteria and undergo a Physical & systemic examination. After obtaining ethics committee approval and registering the study on the Clinical Trial Registry of India (CTRI), eligible participants aged 30–70 years as known cases of hyperglycaemia with or without OHAs will be screened and enrolled. There will be four visits per subject. On visit 1, subjects who consent to participate in the study will be screened based on inclusion-exclusion criteria and undergo a Physical & systemic examination. Trial participants will then be allocated to trial treatment for a duration of 4 months active treatment.