Efficacy of Vijayasaradi capsule as add-on management in insulin-dependent type 2 diabetes – A randomized standard controlled clinical trial

Abstract

BACKGROUND: In patients with hyperglycemia, the resistance to oral antihyperglycemic drugs may lead to insulin therapy. Insulin therapy has some limitations, such as the cost of medicine, dose monitoring, and the risk of hypoglycemia. The classical text of Ayurveda has described several formulations for treating diabetes. The role of Ayurveda antidiabetic formulations needs to be studied for controlling hyperglycemia and reducing the dose and frequency of insulin administration. Vijayasaradi capsule is an antidiabetic herbal formulation mainly utilized to treat hyperglycemia. Objective: This study aimed to evaluate the clinical efficacy of Vijayasaradi capsule as add-on management in the cases of insulin-dependent type 2 diabetes. MATERIALS AND METHODS: Seventy-nine patients of either sex with insulin-dependent diabetes mellitus (T2-IDDM) between 18 and 70 years were studied. The intervention for the control group (n = 38) was hypoglycemic drugs with insulin injections. The trial group (n = 41) was treated with the Vijayasaradi capsule, two capsules (500 mg each) thrice daily before food, hypoglycemic medicine, and insulin injection. The duration of the study was 3 months, and follow-ups were done weekly. Percentage changes of reduction in the units of insulin therapy, fasting and postprandial blood sugar levels, and hemoglobin A1c before and after the treatment and the associated subjective symptoms of type 2 diabetes were the primary outcome measures. RESULTS: The trial drug significantly decreased fasting blood sugar (P = 0.02) and postprandial blood sugar (P = 0.0001). The average insulin dose was also reduced from 33.27 ± 19 to 28.8 ± 80 units. A significant reduction (P = 0.001) in hemoglobin A1c was observed after the treatment. After the treatment, reduction in the maximum average insulin dose was also observed. CONCLUSION: Vijaysaradi capsule can be used as an add-on therapy to manage hyperglycemia and reduce insulin doses in patients with T2-IDDM.