Clinical Evaluation of Chandraprava Vati as Mentioned in Vasabarajiyam, in Patients with Prediabetes: A Randomized Controlled Study

Abstract

Background: Prediabetes represents a high-risk state for progression to type 2 diabetes mellitus. Within the Ayurvedic framework, selected premonitory features of Madhumeha (Purvarupa) have been considered relevant to an early stage of metabolic disturbance. This study evaluated Chandraprava Vatika as an adjunct to dietary restriction and physical exercise in patients described as having Purvarupa of Madhumeha vis-à-vis prediabetes.
Methods: Sixty patients were enrolled and randomly allocated to a trial group (n=30) receiving Chandraprava Vatika 250 mg twice daily and a placebo group (n=30) receiving wheat powder 250 mg twice daily. Both groups received the same dietary and exercise advice and were followed for 30 days, with assessments at baseline, day 15 and day 30. Clinical features included thirst (Pipasa), burning sensation of palms and soles (Karapada Daha), numbness of palms and soles (Karapada Suptata) and lassitude (Alasya). Biochemical outcomes included impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and HbA1c. Within-group changes were assessed using paired t-tests and between-group differences using unpaired t-tests.
Results: By day 30, the reported average percentage improvements in the trial group were 87.76% for Pipasa, 81.57% for Karapada Daha, 93.75% for Karapada Suptata, 96.42% for Alasya, and 100% of participants showing improvement in IFG, IGT and HbA1c, compared with 46.15%, 46.00%, 45.16%, 33.33%, 26.66%, 30.00% and 26.66%, respectively, in the placebo group. The source analysis reported statistically significant within-group improvements and significant between-group differences for most day-30 comparisons.
Conclusion: In this 30-day study, Chandraprava Vatika combined with lifestyle measures was associated with greater improvement in the reported clinical and biochemical measures than placebo.