Abstract
BACKGROUND: Type 2 diabetes mellitus (T2DM) is prevalent in Nepal, with many seeking primary care through Ayurveda, a widely practiced traditional system. However, concerns exist about suboptimal care and variability in clinical practice among Ayurvedic practitioners. No evidence-based clinical practice guideline (EB-CPG) is available for managing T2DM. Therefore, an EB-CPG was developed, and a feasibility study was conducted to inform a future cluster randomized controlled trial (RCT) assessing whether EB-CPG improves T2DM management compared with usual practice. METHODS: A two-arm feasibility cluster RCT was conducted in Ayurveda centers. Centers were randomized (1:1) by an independent statistician. Adults with newly diagnosed, treatment-naïve T2DM and glycated hemoglobin (HbA1c) of 6.5%-< 9% were recruited. Data collectors and the analyst were blinded to group allocation. RESULTS: Fourteen Ayurveda centers were approached, all recruited (seven/group) and completed the study. One center withdrew and did not enroll participants. Of 151 potential participants, 121 (80%) were recruited (60 in intervention and 61 in control). Of those, 84% were followed up to 6 months (51/group). The median adherence score to EB-CPG among practitioners was 1-2 (partial to adequate adherence). The median (interquartile range) number of EB-CPG-recommended medicines not consumed by participants and days without consumption was 0 (0-10) and 0 (0-2.5), respectively. No serious adverse events occurred. Preliminary estimates suggest EB-CPG's beneficial effects on HbA1c, fasting plasma glucose, and health-related quality-of-life, though not statistically significant. CONCLUSION: This feasibility trial demonstrated successful recruitment, follow-up, and intervention adherence. A definitive trial is feasible to evaluate the intervention's effectiveness in T2DM management. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT05259735; first posted on March 02, 2022.