Efficacy of palliative herbal decoction (Darvyadi Kwatha) with lifestyle modification in the management of prediabetes (Prameha): a single-arm clinical trial

Background: Prediabetes is a pathological condition that is characterized by an increase in sugar level within the normal limit and a diagnostic range of diabetes mellitus (DM). Timely untreated prediabetes turns into DM within a year and systemic complications occur, such as retinopathy, nephropathy, neuropathy, etc. During later stages of the disease, all systems of the body are affected. The management of prediabetes includes oral hypoglycemic drugs. Based on signs and symptoms, prediabetes can be correlated to the disease Prameha. Aim and Objectives: Evaluate the efficacy of oral administration of Darvyadi Kwatha (~herbal decoction) with lifestyle modification in prediabetes (Prameha).Materials and Methods: After the approval of Institutional Review Board, Independent Ethics Committee, and clinical trial registration in CTRI, 20 patients suffering with Prameha (~prediabetes) were registered in the clinical trial. Assessment criteria were: reduction in glycated hemoglobin (HBA1c), fasting plasma glucose (FBS), postprandial plasma glucose (PPBS), improvement in Agnibala (~strength of digestion and metabolism), Dehabala (~physical strength), and Satvabala (~mental strength), relief in signs and symptoms of prediabetes, and improvement in quality of life (SF-36 Score). Oral administration of Darvyadi Kwatha and lifestyle modification was given. Assessment was done on the 46th, 76th, 107th, and 120th day and Student paired t-test was used for analysis of data. Results: The outcomes showed a statistically highly significant reduction in assessment parameters (HBA1c [mean ± standard deviation [SD] before treatment [BT] 6.07 ± 0.26 and after treatment [AT] 5.78 ± 0.22] [<0.001], FBS [mean ± SD BT 116.6 ± 12.5 and AT 102.0 ± 0.8.1] [<0.001], and PPBS [mean ± SD BT 168.7 ± 19.7 and AT 118.6 ± 12.0] [<0.001]). Conclusion: This clinical study concludes that Ayurveda medicine (Darvyadi Kwatha and lifestyle modification) is effective in the treatment and prevention of prediabetes turning into DM.