Efficacy of Ayurveda treatment protocol in the management of prediabetes- A randomized controlled clinical trial

BACKGROUND: Prediabetes is a subject of intermediate hyperglycaemia and a risk factor for various metabolic and cardiovascular diseases, which are silent in features. Early Screening and preventive measures in terms of diet and lifestyle modification can help reverse the prediabetic stage. OBJECTIVE: To evaluate the efficacy of Ayurveda-based treatment protocol in the management of prediabetes and to compare it with the standard prediabetic care. MATERIALS AND METHODS: A total of 40 patients meeting the criteria of HbA1C 5.7-6.4% and Indian diabetic risk Score of ≥60, with the age group of 18-70 years of either sex, participated in the study. They were randomly divided into two groups in which trial group, intervened with Integrated Ayurveda Treatment Protocol (IATP) contains Triphala lauha churna 3 g twice a day along with Ayurveda dietary and lifestyle intervention and control group received placebo powder 3 g twice a day for 90 days along with standard prediabetic care (SPC). The primary endpoints were changes in glycated hemoglobin (HbA1C), fasting blood glucose (FBG), postprandial blood glucose (PPBG), and secondary endpoints were lipid profile, diabetes quality of life (DQOL), and anthropometric measures. RESULTS: Study data indicate that IATP showed significant improvement in HbA1C compared to the SPC (p < 0.001). IATP also showed significant improvement in FBG (p < 0.001), PPBG (p = 0.0003), total cholesterol (p = 0.0004), high density lipoprotein (p = 0.003), low density lipoprotein (p = 0.01), serum triglycerides (p = 0.003), serum creatinine (p = 0.0011) and DQOL (p < 0.001). Comparable outcomes were noted in weight (p = 0.24), BMI (p = 0.05), and waist-hip ratio (p = 0.06). CONCLUSION: IATP intervention showed significant improvement in glycaemic outcomes, lipid profile compared to the SPC group. Comparable outcomes were observed in anthropometric measures.