Development and Validation of Diagnostic Tool for Janu Sandhigata Vata with Special Reference to Knee Osteoarthritis- Mixed-Method Diagnostic Validation Study Protocol
DOI:
https://doi.org/10.70066/jahm.v14i7.2754Keywords:
Ayurveda, Diagnostic tool, osteoarthritis, Protocol, sandhigata vata, validationAbstract
Background: In Ayurveda, emphasis is placed on proper diagnosis before giving treatment. A proper diagnosis involves comprehensive assessment of multiple factors like Dosha, Dhatu etc. This personalized framework is influenced by physicians' perception there causing variability in clinical judgement. Standardization, reproducibility, and objectivity of diagnostic tools are increasing and contemporary science has well established it. Unlike Ayurveda which relies on classical texts and physicians’ expertise. This gap creates challenges in ensuring uniformity in diagnosis, especially in clinical research, interdisciplinary practice and evidence- based validation. Development of diagnostic tool is needed to bridge this gap and enhance the credibility of Ayurvedic diagnosis. Sandhigata vata is a leading disease treated in Ayurveda and diagnosed based on Laxana due to vata vitiation. No standard diagnostic tool is available for it. Objective: To diagnose osteoarthritis using Ayurvedic and modern diagnostic approaches and to develop and validate a standardized diagnostic tool/process for Janu Sandhigata Vata. Methodology: The study will be conducted in four phases. Phase I will identify questionnaire items and response options through literature review, survey, focus group discussions, and in-depth interviews. Phase II will involve pre-testing of the items and response scales among Ayurveda physicians and patients with Janu Sandhigata Vata. Phase III will involve domain reduction and expert item revision to retain relevant items and remove unsuitable ones. Phase IV will assess the validity and reliability of the developed diagnostic tool. Both qualitative and quantitative methods will be employed, followed by appropriate statistical analysis. Results: In January 2025 present study was initiated. It includes both qualitative and quantitative Methods. All four phases followed by statistical analysis is expected to be completed by June 2027. Conclusion: This study protocol is designed to develop and validate a diagnostic tool/ process and develop standard methodology to diagnose diseases in Ayurveda.
References
Shastri K & Chaturvedi GN (editor).Commentary: Vidyotini teeka Hindi on Charaka Samhita of Charaka, Chikitsasthana, Chapter 28, Verse 37, 2nd edition, Varanasi; Chaukhambha Bharati Academy; 2015;783.
National AYUSH Morbidity and Standardized Terminologies Portal (NAMSTP) [homepage on the Internet]. New Delhi: Ministry of AYUSH, Government of India; [cited 2026 Apr 7]. Available from: https://namstp.ayush.gov.in/#/index
World Health Organization. WHO global report on traditional and complementary medicine 2019 [monograph on the Internet]. Geneva: World Health Organization; 2019 [cited 2026 Apr 7]. Available from: https://iris.who.int/bitstream/handle/10665/365543/9789240064935-eng.pdf
Witt CM, Michalsen A, Roll S, et al. Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee – study protocol for a randomized controlled trial. Trials. 2013 May;14:149. Available from: https://doi.org/10.1186/1745-6215-14-149
World Health Organization. Osteoarthritis [homepage on the Internet]. Geneva: World Health Organization; [cited 2026 Apr 7]. Available from: https://www.who.int/news-room/fact-sheets/detail/osteoarthritis
Singh A, Das S, Chopra A, Danda D, Paul BJ, March L, et al. Burden of osteoarthritis in India and its states, 1990-2019: findings from the Global Burden of disease study 2019. Osteoarthritis Cartilage. 2022;8:1070-1078. Available from: https://doi.org/10.1016/j.joca.2022.05.004
Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020;29–30:100587. Available from: https://doi.org/10.1016/j.eclinm.2020.100587
Pal CP, Singh P, Chaturvedi S, Pruthi KK, Vij A. Epidemiology of knee osteoarthritis in India and related factors. Indian J Orthop. 2016;50(5):518–522. Available from: https://doi.org/10.4103/0019-5413.189608
Rastogi S, Pandey P, Kumar S, Verma A, RC. ‘Obesity and arthritis’ as the morbid duo: Designing and experimenting a novel strategy for weight reduction at a secondary care Ayurveda arthritis center. J Ayurveda Integr Med. 2023;14(5):100722. Available from: https://doi.org/10.1016/j.jaim.2023.100722
Edavalath M, Bharathan BP. Methodology for developing and evaluating diagnostic tools in Ayurveda: A review. J Ayurveda Integr Med. 2021;12(2):389–397. Available from: https://doi.org/10.1016/j.jaim.2021.01.009
Anthoine E, Moret L, Regnault A, Sébille V, Hardouin JB. Sample size used to validate a scale: a review of publications on newly developed patient-reported outcome measures. Health Qual Life Outcomes. 2014; 12:176. Available from: https://doi.org/10.1186/s12955-014-0176-2
McCallum GB, Morris PS, Wilson CC, Versteegh LA, Ward LM, Chatfield MD, et al. Severity scoring systems: are they internally valid, reliable and predictive of oxygen use in children with acute bronchiolitis? Pediatr Pulmonol. 2013;48(8):797–803. Available from: https://doi.org/10.1002/ppul.22725
Costello AB, Osborne J. Best practices in exploratory factor analysis: four recommendations for getting the most from your analysis. Pract Assess Res Eval. 2005;10:1–9. Available from: https://doi.org/10.7275/jyj1-4868
Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019; 393:1745–1759. Available from: https://doi.org/10.1016/S0140-6736(19)30417-9
Vos T, Allen C, Arora M, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis. Lancet. 2016;388:1545–1602. Available from: https://doi.org/10.1016/S0140-6736(16)31678-6
Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019;27:1578–1589. Available from: https://doi.org/10.1016/j.joca.2019.06.011
Suri P, Morgenroth DC, Hunter DJ. Epidemiology of osteoarthritis and associated comorbidities. PM R. 2012;4(5 Suppl):S10–S19. Available from: https://doi.org/10.1016/j.pmrj.2012.01.007
Safiri S, Kolahi AA, Smith E, et al. Global, regional and national burden of osteoarthritis 1990–2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020;79:819–828. Available from: https://doi.org/10.1136/annrheumdis-2019-216515
Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008;58:26–35. Available from: https://doi.org/10.1002/art.23176
Sharma A, Shalini TV, Sriranjini SJ, Venkatesh BA. Management strategies for Janu Sandhigata Vata vis-à-vis osteoarthritis of knee: A narrative review. Ayu. 2016;37(1):11–17. Available from: https://doi.org/10.4103/ayu.AYU_24_16
Brooks L. Epistemology and embodiment: diagnosis and the senses in classical Ayurvedic medicine. 2018;6:98–135. Available from: https://doi.org/10.1163/22879811-12340027
Salehi-Abari I. 2016 ACR revised criteria for early diagnosis of knee osteoarthritis. Autoimmune Dis Ther Approaches. 2016;3(1):118. doi:10.14437/2378-6337-3-118
Wang Q, Runhaar J, Kloppenburg M, Boers M, Bijlsma JWJ, Bierma-Zeinstra SMA, et al. Evaluation of the diagnostic performance of American College of Rheumatology, EULAR, and National Institute for Health and Clinical Excellence criteria against clinically relevant knee osteoarthritis: data from the CHECK cohort. Arthritis Care Res (Hoboken). 2024;76(4):511-6. doi:10.1002/acr.25270
Peat G, Thomas E, Duncan R, Wood L, Hay E, Croft P. Clinical classification criteria for knee osteoarthritis: performance in the general population and primary care. Ann Rheum Dis. 2006;65(10):1363-7. doi:10.1136/ard.2006.051482
Skou ST, Koes BW, Gronne DT, Young J, Roos EM. Comparison of three sets of clinical classification criteria for knee osteoarthritis: a cross-sectional study of 13,459 patients treated in primary care. Osteoarthritis Cartilage. 2020;28(2):167-72. doi:10.1016/j.joca.2019.09.003
Bhapkar V, Nisargand V, Godatwar P, Bhalerao S. Research status of traditional & complementary medicine systems across the world. J Ayurveda Integr Med. 2025;16(2):101078. Available from: https://doi.org/10.1016/j.jaim.2024.101078
Bhosale A, Satpute S, Thorat S, Puradkar G. Integration of modern investigations with Ayurvedic diagnosis: a review. Int J Multidiscip Res. 2025. Available from: https://doi.org/10.36948/ijfmr.2025.v07i05.57093
Brar BS, Chhibber R, Srinivasa VM, Dearing BA, McGowan R, Katz RV. Use of Ayurvedic diagnostic criteria in Ayurvedic clinical trials: a literature review focused on research methods. J Altern Complement Med. 2012;18(1):20–28. Available from: https://doi.org/10.1089/acm.2010.0671
Khairnar V, Kripashree K, Mouri K, Chainani V. Modernizing tradition: integrating Ayurvedic diagnostic wisdom with modern medical science. World J Biol Pharm Health Sci. 2025. Available from: https://doi.org/10.30574/wjbphs.2025.24.3.1050
Edavalath M, Bharathan BP. Methodology for developing and evaluating diagnostic tools in Ayurveda: a review. J Ayurveda Integr Med. 2021;12(2):389–397. Available from: https://doi.org/10.1016/j.jaim.2021.01.009
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