CLINICAL STUDY TO COMPARE THE HYPOGLYCEMIC EFFECT OF VIJAYSARGHANA VATI AND MAMAJJKAGHANA VATI IN MADHUMEHA~TYPE-2 DIABETES MELLITUS: PROTOCOL OF A CLINICAL COMPARATIVE STUDY

Background: Madhumeha is a condition described in Ayurveda which has been correlated with Type-2 Diabetes Mellitus. It is one of the types of Vataja Prameha. Describing the Prameha, it has been mentioned it is group of disorders in which there is increased frequency of micturition, the volume of urine is also increased and the urine becomes turbid. According to Acharya Charak, Madhumeha is also called Ojomeha. Aim and Objective: To compare the efficacy of Vijaysarghana Vati and Mamjjakghana Vati in Madhumeha~Type-2 Diabetes mellitus. Material and Method: This is a single-centre, open-label, randomized, comparative clinical study. Total 60 subjects in each group 30. Group A will receive Vijaysarghana Vati (500 mg, 2 tablets BD) and Group B will receive Mamajjakaghana Vati (500 mg, 2 tablets BD), both orally with plain water, empty stomach, 30 minutes before meals, for 90 days, followed by a 15-day follow-up. Outcomes will be assessed using fasting and postprandial blood glucose, HbA1c, and cardinal subjective symptoms of Madhumeha, recorded on Days 0, 1, 30, 60, 90 and at follow-up (Day 105). Expected Outcome: This study is expected to improvement in the biochemical parameters of Diabetes mellitus and clinical features of Madhumeha described in Ayurvedic texts.