Status of Evidence on the Efficacy and Safety of Indian Traditional Medicine for Prediabetes and Type 2 Diabetes Mellitus: Protocol for a Systematic Review and Evidence Map Synthesis.

Background: Noncommunicable diseases, particularly diabetes, pose a growing global burden, with India disproportionately affected. India also has a rich repository of traditional medical systems-Ayurveda, yoga and naturopathy, Unani, Siddha, Sowa Rigpa, and homeopathy (AYUSH)-collectively governed under the Ministry of Ayush. These systems adopt a personalized and integrative approach to diabetes management, addressing glycemic control alongside metabolic and lifestyle factors. Despite growing use and evidence for AYUSH interventions, standardized evaluation methods remain limited. Objective: This study aims to quantitatively evaluate the evidence status for AYUSH interventions for the management of prediabetes and type 2 diabetes mellitus and establish a road map of evidence through research for better outcomes in the future. Methods: The systematic review will be conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and is registered in PROSPERO. All primary study designs, including randomized controlled trials, nonrandomized controlled trials, parallel-arm intervention trials, pretest-posttest trials, observational studies (including cross-sectional, case-control, and cohort studies), and case series and case reports will be assessed. Systematic reviews and meta-analyses will be screened for background information and identification of relevant primary studies but will not be included in the evidence synthesis. Studies involving AYUSH interventions either as stand-alone therapies or as an add-on to standard care will be reviewed. Electronic databases along with AYUSH-specific sources, including PubMed, CENTRAL, clinical trial registries, AYUSH Research Portal, MEDLINE, Scopus, Web of Science, Embase, Digital Helpline for Ayurveda Research Articles, and IndMED, will be searched using database-specific search strategies combining AYUSH-related and diabetes-specific keywords with Boolean operators. Outcome measures will include clinical recovery, biochemical parameters, quality of life, and adverse events. Data will be synthesized systematically and represented through an evidence map. Results: Database searches and pilot-testing of strategies are planned to commence in September 2025. Screening of eligible studies, data extraction, and quality assessment are planned for December 2025; data compilation and manuscript preparation will be conducted from July 2026 to October 2026; and the final systematic review and evidence map are anticipated by December 2026. Publication of the results is expected in early 2027. Anticipated findings will include a systematic integration of data relevant to the efficacy and safety profiles of AYUSH interventions for prediabetes and type 2 diabetes accompanied by an evidence map showcasing the allocation and reliability of the current evidence base on different AYUSH modalities. Conclusions: This review seeks to consolidate and evaluate existing data to facilitate evidence-based integration of Indian traditional medicine in diabetes management. The resulting evidence map will serve as a strategic tool for clinical research, health care policy, and future systematic reviews in the field of integrative medicine.