Exploratory Clinical trial on the Effect of Panchatiktaka Niruha Basti in modulating Gut microbiome in Type II Diabetes Mellitus

Type II Diabetes mellitus is a metabolic disorder of increasing global prevalence, significantly impacting quality of life through complications like neuropathy, nephropathy and cardiovascular disease. Ayurveda identifies T2DM under the umbrella of Madhumeha, where Kapha and Meda vitiation play a central pathogenic role. Panchatiktaka Niruha Basti, a medicated enema therapy described in Ayurvedic texts, is traditionally indicated in the management of Prameha, including Madhumeha, and is proposed to exert systemic effects via the gut. The aim of this study is to evaluate the efficacy of Panchatiktaka Niruha Basti in modulating gut microbiome composition and improving glycemic parameters in patients with T2DM. A single-arm Exploratory clinical trial will be conducted on T2DM patients aged 40–70 years meeting specific inclusion and exclusion criteria. The intervention involves administration of Panchatiktaka Niruha Basti (612 ml) for 7 consecutive days following standard Ayurvedic preparatory procedures. Stool samples will be collected pre- and postintervention for gut microbiome analysis using 16S rRNA sequencing. Alpha and beta diversity will be performed to understand changes in richness and evenness (within sample diversity) and microbial community composition (between sample diversity) pre and post intervention. Clinical assessments and glycemic markers (FBS, PPBS, HbA1c) will be

recorded. Data will be analyzed using appropriate statistical tools, including PERMANOVA, to detect shifts in bacterial diversity and relative abundance.