Methodological Framework Proposed to Standardize Ayurvedic Clinical Trial Protocols

Researchers have proposed a methodological framework and eleven candidate reporting extensions to adapt clinical trial protocol standards for Ayurvedic whole-system interventions. Developed by a team including Satyajit Pandurang Kulkarni, Bharat Rathi, Shweta Parwe, and Pallavi Kulkarni, the proposal builds on the EQUATOR Network guideline development process to integrate reproducibility, transparency, and open-science principles into Ayurvedic research. The authors designed the candidate extensions for future Delphi consensus evaluation rather than immediate clinical implementation.

The initiative addresses longstanding challenges in applying standard protocol reporting frameworks to individualized, multi-modal interventions. While the updated SPIRIT 2025 statement introduced a dedicated open-science section comprising 34 minimum protocol items following a Delphi consensus involving 317 participants, whether this framework can accommodate the multi-modal logic of Ayurvedic whole-system research has remained unarticulated. The proposed framework examines how those open-science provisions can be systematically operationalized within Ayurvedic clinical trials.

To establish the necessity of tailored reporting standards, the authors synthesized published evidence documenting substantial transparency gaps in registered trials. Across Traditional Indian Medicine trials, only 64.8 percent reported randomization, falling below the 75.4 percent reported for Traditional Chinese Medicine. Additionally, a cited 2017 audit revealed that 73.6 percent of 507 Ayurvedic trials registered in the Clinical Trials Registry – India were registered retrospectively. This historical baseline predated the registry’s April 2018 prospective-only mandate, leaving post-2018 compliance an open empirical question.

Drawing on the precedent of established SPIRIT extensions and the Good Clinical Trials for Traditional Medicine consensus, the investigators outlined eleven candidate extensions designated AE1 through AE11. The framework incorporates a methodological roadmap encompassing prospective trial registration, open-data deposition, protocol preprinting, and material standardization. The proposed evaluation process adapts the modified nominal-group technique used by SPIRIT-CHMF 2025, defining consensus a priori as at least 70 percent of Delphi panelists rating an item as critical and under 15 percent rating it of limited importance on a nine-point Likert scale, followed by pilot testing.

The authors conclude that an evidence-based reporting extension can serve as a methodological bridge between Ayurvedic epistemology and the global evidentiary ecosystem. This standardization is particularly urgent given cross-sectional survey findings indicating that while 76.0 percent of complementary, alternative, and integrative medicine researchers publish in open-access venues, only 48.0 percent register study protocols and even fewer deposit raw data. Future evaluation of protocol sharing, pre-specified analytical plans, and transparent diagnostic reporting aims to foster a more reproducible research culture.

Subject of Research: Methodological reporting framework for Ayurvedic clinical trial protocols

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

Article References: Kulkarni, S. P., Rathi, B., Parwe, S., & Kulkarni, P. (2026). Towards a SPIRIT–Ayurveda extension: a methodological framework for reporting guideline development. BMC Medical Research Methodology. https://doi.org/10.1186/s12874-026-03081-y

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DOI: 10.1186/s12874-026-03081-y

Keywords: Ayurveda, clinical trial protocols, SPIRIT guidelines, open science, EQUATOR Network, reproducibility, traditional medicine, research methodology, Towards, SPIRIT, extension, methodological