Heliyon (Feb 2025)
A randomized multi-arm open labelled comparative clinical trial report of Pankajakasthuri DiabetEaze powder, a novel polyherbal formulation on the nutritional management and glycemic control in type 2 diabetic and prediabetic patients
Abstract
Background and aims: Recently Diabetes Mellitus (DM) has been associated with heightened susceptibility to malnutrition, suggesting that augmenting nutritional intake stands out as a potent therapeutic strategy for addressing malnutrition in individuals with DM. The aim of this clinical investigation was to evaluate the effect of DiabetEaze powder, a polyherbal nutritional formulation developed by us for nutritional management and glycaemic control, on patients with diabetic and prediabetic conditions. Methods: A total of 143 type II diabetic (T2D) patients who were managing their diabetic condition through modern medicine, AYUSH medicine, lifestyle modification and 68 pre-diabetic patients, aged between 40 and 65 years, were randomly assigned into six groups: control, modern, AYUSH, lifestyle, prediabetic control and prediabetic trial. The treatment groups were administered 5 g of DiabetEaze powder two times a day after food for 6 months. Microminerals, vitamins, glycaemic parameters, Quality of Life (QoL), hematology, lipid profiles, Renal Function Test (RFT) and Liver Function Test (LFL) parameters, and electrolytes were evaluated at Day 0, Day 90, and Day 180. Results: Out of 211 enrolled patients, 189 individuals successfully completed the entire 180-day duration of the study, indicating a retention rate of approximately 89.6 %. In our study, we observed a statistically significant elevation in the levels of vitamin D, B2, and B6 across all treatment groups. Besides, the treatment groups displayed a notable increase in zinc and manganese levels compared to the other minerals tested. Notably, the treatment groups demonstrated distinct mineral and vitamin profiles. In terms of metabolic markers, significant reductions in Fasting Blood Sugar (FBS)/Post Prandial Blood Sugar (PPBS) were observed across the modern, AYUSH, and lifestyle groups, while the modern group also showed a marked decrease in glycated haemoglobin (HbA1c) levels. Furthermore, overall QoL among the tested groups was also statistically significant. The consistent maintenance of normal LFT and RFT parameters and electrolyte levels across trial groups throughout the study duration indicates that the supplement does not induce liver toxicity or negatively impact hepatic function. Conclusion: In conclusion, the nutrients present in the DiabetEaze powder contribute to the effective management of nutritional status in diabetic people and thus effectively reduce sugar spikes by regulating PPBS and HbA1c levels, which is a critical aspect of its role in diabetes management. These properties benefit in managing diabetes-related outcomes and overall quality of life. Clinical trial registry of India under registration no: CTRI/2021/04/032956 on 20/04/2021.
