An Open-Label, Randomized Controlled Trial to Determine the Efficacy of Standard Oral Anti-diabetic agents combined with Aavarai Kudineer Tablets Versus Standard Oral Anti-diabetic agents Alone in the Management of Type 2 Diabetes Mellitus at National Institute of Siddha, Chennai

Aavarai Kudineer (AK), a classical Siddha polyherbal formulation documented in Theraiyar Kudineer and Gunapadam Mooligai Vaguppu, has been traditionally used to manage diabetes. Comprising seven herbs, AK has demonstrated promising anti-diabetic potential in preclinical studies. In vitro, it significantly enhanced glucose

uptake in L-6 myotubes . In vivo, AK improved glucose tolerance and significantly reduced hyperglycemia in alloxan-induced diabetic rats, while also normalizing urea, creatinine, and cholesterol levels—indicating nephroprotective effects. Further investigations into individual ingredients of AK reinforce its therapeutic potential not

only in reducing blood sugar level but also in reversing micro angiopathic changes which results in complications: Cassia auriculata root extract protected against cisplatin- and gentamicin-induced renal injury. Cassia fistula fruit extract reduced bromobenzene-induced nephrotoxicity. Syzygium cumini seed extract decreased elevated urea and creatinine in STZ-induced diabetic rats. Costus spicatus showed nephron protective activity against rhabdomyolysis-induced acute kidney injury. Terminalia arjuna bark, with strong antioxidant properties, mitigated acetaminophen-induced nephrotoxicity and oxidative stress .The clinical proficiency of the drug was found in a non-randomized, open-label clinical study conducted in National Institute of Siddha (an unpublished study), this study evaluated the therapeutic potential of the Aavarai Kudineer (AK) decoction in prediabetic and diabetic patients over a 90-day period. The results demonstrated statistically significant improvements in glycemic and lipid parameters, particularly in the diabetic group. A marked reduction in HbA1c levels was observed in the diabetic group (from 9.2% to 7.7%, along with significant improvements in fasting blood glucose, BMI, and HOMA-IR, indicating enhanced beta-cell function. In the prediabetic group, there was a significant decrease in postprandial blood glucose (from 145.80 to 134.80 mg/dL) and total serum cholesterol levels. Both groups exhibited reduced microalbuminuria, suggesting nephroprotective action of the formulation. In this context, AK is expected as a promising therapeutic agent, which may offer a holistic benefit in

the management of diabetes and its associated complications. However, this preliminary study was not a randomized controlled trial (RCT), and the intervention was administered as a classical decoction rather than in tablet form. The current proposal intends to address these limitations by evaluating the clinical efficacy of Aavarai Kudineer in a standardized tablet formulation which may improve patient adherence, using a robust RCT design to strengthen evidence for its use as an adjunct therapy in managing uncontrolled type 2 diabetes mellitus. Given these pharmacological attributes, the integration of AK into contemporary diabetes care

represents a potentially valuable adjunct approach. This study, therefore, proposes the hypothesis that an integrated treatment strategy incorporating Aavarai Kudineer tablets administered over 90 days can significantly enhance glycemic control and metabolic outcomes in patients with T2DM.