A protocol for systematic review and meta-analysis on the efficacy and safety of nutraceuticals with special reference to Ahara Dravya (food articles) in type 2 diabetes mellitus

Different Aushadi (drugs) are indicated for Prameha (diabetes mellitus) in Ayurveda, with some serving as nutraceuticals. Still, their efficacy and safety need to be investigated. A systematic review will be conducted, including both published and relevant unpublished randomized controlled trials of selected nutraceuticals in diabetes mellitus. For the meta-analysis, only published studies will be considered. Searches will be executed in PubMed, Cochrane Central Register of Controlled Trials, Shodhganga: A reservoir for Indian theses, Digital Helpline for Ayurveda Research Articles, and AYUSH Research Portal, along with dissertation and thesis works in the public domain, unpublished studies from websites of university/institution, as well as other possible sources. Two reviewers will independently select studies, extract data, and synthesize results. A third reviewer will address disagreement. Robinson Risk of Bias 2 tool will be used to evaluate bias. Meta-analysis of extracted data will be performed through Review Manager Web software focusing on fasting blood sugar levels and glycosylated hemoglobin and reported adverse events if any. The strength of the shreds of evidence and reliability will be analyzed using the Grading of Recommendations, Assessment, Development, and Evaluation system. Findings will be presented using appropriate statistical methodology and interpreted accordingly. This study will comprehensively assess the selected nutraceuticals in type 2 diabetes mellitus (T2DM), demonstrating their efficacy and safety in preventing and managing T2DM. The conclusion may be drawn based on the resultant outcome of the impact of selected nutraceuticals on T2DM. PROSPERO registration number: CRD42024529448.