Comparative effect of composite management of type II diabetes mellitus with induced emesis and Varadi Ghanavati: A pilot clinical study.

INTRODUCTION: Ayurveda offers a rational view in the management of Prameha. Shodhana (∼bio-purification) is advocated as the first line of treatment to eliminate Kapha, which is followed by palliative treatment to further control disease pathology. Evaluation of such composite treatment has rarely been published. The present study was conducted to assess the comparative efficacy and safety of three interventions in the management of Prameha (Diabetes mellitus type II (T2DM)) - (a) Vamana (induced emesis) and Varadi Ghanavati (oral Ayurvedic medication), (b) Varadi Ghanavati, and (c) glibenclamide. METHODS: It was open labelled, comparative, randomised, prospective, three arm pilot study. A total 49 patients, newly diagnosed or known cases of Prameha (T2DM) were randomised in three groups. The first group (Vamana) received Vamana followed by Varadi Ghanavati (500 mg (mg) thrice daily before food for 12 weeks). The second (Varadi) group received Varadi Ghanavati without prior Vamana, while, the control group received glibenclamide 5 mg twice daily before food for 12 weeks. Patients were evaluated at intervals of each four weeks. Assessment was done on changes seen in blood sugar (BSL) fasting (F), postprandial (PP), glycosylated haemoglobin, lipid profile, body mass index (BMI) and clinical symptoms. RESULTS: Patients in all groups showed better glycaemic control as compared to baseline. Mean BSLF before and after treatment were 166.20 ± 78.39 mg/dL and 125.00 ± 58.77 mg/dL in Vamana group (p < 0.01), 163.60 ± 59.34 mg/dL and 127.73 ± 37.94 mg/dL in Varadi group (p < 0.05), while 163.00 ± 59.03 mg/dL and 129.40 ± 41.91 mg/dL in control (p < 0.05). Similarly, BSL PP values before and after treatment were 254.47 ± 99.59 mg/dL and 178.47 ± 68.45 mg/dL in Vamana group (p < 0.01), 233.93 ± 68.95 mg/dL and 185.20 ± 56.73 mg/dL in Varadi group (p < 0.05), 239.80 ± 77.10 mg/dL and 182.53 ± 42.14 mg/dL in control (p < 0.05). Glycosylated haemoglobin, mean values before and after treatment were 8.23 ± 1.71% and 7.18 ± 1.96% in Vamana group (p < 0.05), 7.83 ± 1.21% and 6.75 ± 1.13% in Varadi group (p < 0.05), 7.17 ± 1.12% and 6.60 ± 0.65% in glibenclamide group (p < 0.05). Comparative evaluation in the three groups showed that there was a statistically significant reduction (p < 0.001) in total cholesterol, low-density lipoproteins (LDL) and BMI in Vamana group as compared the other groups. No adverse event was observed. CONCLUSION: Along with better glycaemic control, composite treatment can reduce deranged lipids and BMI, which can help in better management of Prameha (T2DM). Vamana and Varadi Ghanavati can be administered safely. CLINICAL TRIAL REGISTRATION NO: CTRI/2017/10/010127.