Development and Validation of Diagnostic Tool for Janu Sandhigata Vata with Special Reference to Knee Osteoarthritis- Mixed-Method Diagnostic Validation Study Protocol

Authors

  • Hemlata Shete
  • Suhas Kumar Shetty
  • Sarang Shete

DOI:

https://doi.org/10.70066/jahm.v14i7.2754

Keywords:

Ayurveda, Diagnostic tool, osteoarthritis, Protocol, sandhigata vata, validation

Abstract

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.

Author Biographies

Hemlata Shete

Associate professor, Department of Roganidana

KAHER’S Shri BMK Ayurveda Mahavidyalaya, Belagavi, India

Suhas Kumar Shetty

Professor Department of Manasroga

KAHER’S Shri BMK Ayurveda Mahavidyalaya, Belagavi, INDIA

Sarang Shete

Associate professor, Department of orthopedics, KAHER’S JNMC , Belagavi, INDIA

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

Additional Files

Published

2026-08-22

How to Cite

Shete, H., Shetty , S. K. ., & Shete, S. . (2026). Development and Validation of Diagnostic Tool for Janu Sandhigata Vata with Special Reference to Knee Osteoarthritis- Mixed-Method Diagnostic Validation Study Protocol . Journal of Ayurveda and Holistic Medicine (JAHM), 14(7), 26-35. https://doi.org/10.70066/jahm.v14i7.2754

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