Towards a SPIRIT–Ayurveda extension: a methodological framework for reporting guideline development

Abstract Background Protocol transparency is a cornerstone of reproducible health research, yet clinical trial protocols for whole-system interventions such as Ayurveda remain underserved by current reporting standards. SPIRIT 2025 introduced a dedicated open-science section and now comprises 34 minimum protocol items; however, whether this framework—designed by a Delphi consensus involving 317 participants—can accommodate the multi-modal, individualized logic of Ayurvedic whole-system research, and whether its open-science provisions can be operationalized for Ayurvedic trials, has not been articulated. Main text Building on the EQUATOR Network’s framework for reporting-guideline development, we propose a conceptual framework and eleven candidate SPIRIT–Ayurveda extension items for future Delphi evaluation, rather than immediate implementation. The proposed framework integrates reproducibility, transparency, and open-science principles into protocol reporting for whole-system Ayurvedic clinical trials. We synthesize evidence of transparency gaps in registered Ayurvedic trials: only 64.8% of Traditional Indian Medicine trials reported randomization, below the 75.4% reported in Traditional Chinese Medicine, and a 2017 audit found that 73.6% of 507 CTRI-registered Ayurvedic trials were registered retrospectively — a historical baseline that predates CTRI’s April 2018 prospective-only registration mandate, leaving post-2018 compliance an open empirical question. We follow the precedent of established SPIRIT candidate extensions and the Good Clinical Trials for Traditional Medicine consensus, to propose 11 candidate Ayurveda-specific extensions (AE1–AE11), alongside a roadmap that includes prospective registration, open-data deposition, protocol preprinting, and material standardization. The development process is modeled on the modified nominal-group technique used by SPIRIT-CHMF 2025, with consensus defined a priori as ≥ 70% of the Delphi panel rating an item as critical (7–9 on a 9-point Likert scale) and < 15% rating it as limited importance; followed by pilot testing. Conclusion A proposed SPIRIT–Ayurveda extension grounded in reproducibility and open-science principles can act as a methodological bridge between Ayurvedic epistemology and the global evidentiary ecosystem—particularly given that a cross-sectional survey found 76.0% of complementary, alternative, and integrative medicine researchers actively publish open access but only 48.0% register study protocols and even fewer share raw data. Future evaluation of protocol sharing, pre-specification of analysis plans, and transparent reporting of traditional diagnostic criteria could contribute to a more reproducible research culture in Ayurvedic clinical research.