A Protocol for Developing and Validating an Ayurveda Diagnostic Algorithm for Chronic Kidney Disease: A Mixed Methods Observational Protocol

Background: Chronic kidney disease (CKD) is a growing global health challenge, largely driven by diabetes and hypertension. Current diagnostic frameworks, such as the Kidney Disease: Improving Global Outcomes guidelines, rely on estimated glomerular filtration rate and albuminuria but provide limited insight into the heterogeneous symptom burden affecting quality of life and individualized care. In India, CKD prevalence ranges from 10% to 17%, indicating a substantial public health burden. Although classical Ayurvedic texts do not describe CKD as a single disease entity, they document urinary and systemic disorders involving Mutravaha and other Srotas that parallel CKD manifestations. Despite emerging evidence supporting Ayurveda for quality-of-life improvement in CKD, a validated and systematic Ayurvedic diagnostic algorithm is lacking. Methods: This study will follow structured, sequential phases integrating qualitative inquiry, expert consensus, psychometric validation, and data-driven pattern recognition. An observational phase will inform the development of a symptom assessment tool, followed by content validation and psychometric testing. Exploratory Factor Analysis and cluster-based methods will identify distinct CKD presentation patterns, which will be synthesized into an Ayurvedic diagnostic algorithm. The algorithm will be evaluated for diagnostic accuracy using sensitivity and specificity, with identification of Ayurvedic CKD phenotypes as a secondary outcome. Expected Outcomes: The study is expected to yield a psychometrically validated Ayurvedic diagnostic algorithm capable of reliably identifying CKD-related clinical patterns. Validation targets include internal consistency (Cronbach’s α ≥ 0.70), interrater and test-retest reliability (intraclass correlation coefficient ≥ 0.75), factor retention (eigenvalues > 1.0), and factor loadings ≥ 0.40. The algorithm will support objective assessment of Dosha, Dushya , and Srotas involvement and enhance clinical usability in Ayurvedic and integrative practice. Conclusion: By integrating expert consensus with quantitative validation, this study represents an early step toward a validated Ayurvedic diagnostic framework for CKD, with potential to enhance diagnostic precision, support individualized treatment strategies, and improve clinical insight, though findings may be limited by single-center sampling. Trial Registration: Prospectively registered in CTRI with registration no-CTRI/2024/05/067083.