Real-World Multicentre Observational Study and Phytochemical Profiling of Mahabala Tailam: Physician- Reported Usage Patterns and Clinical Perceptions from India

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Abstract

Background: Mahabala Tailam is a classical Ayurvedic medicated oil described in the Bhaishajya Ratnavali and widely prescribed for musculoskeletal, neurological, and reproductive health conditions. Despite its extensive clinical use, systematic documentation of real-world prescribing patterns, physician-reported clinical experiences, and phytochemical characteristics of the formulation remains limited. Integrating practitioner perspectives with chemical profiling may help contextualize traditional use and inform future clinical research. Aim To document real-world usage patterns, indications, and physician-reported perceptions of clinical utility of Mahabala Tailam among Ayurvedic physicians in India, and to characterize the phytochemical profile of the marketed formulation using GC–MS analysis. Materials and Methods A descriptive cross-sectional survey was conducted among 303 registered Ayurvedic physicians across India using a validated questionnaire to capture prescribing patterns, indications, modes of administration, and physician-reported perceptions of clinical utility. Questionnaire validation included face validity, item-wise content validity index, and scale-level content validity index. Descriptive statistics, chi-square tests, Spearman’s correlation, regression analysis, and collinearity diagnostics were applied to explore associations between physician characteristics and reported perceptions. Phytochemical profiling of Mahabala Tailam was performed using gas chromatography–mass spectrometry (GC–MS) with compound identification based on retention indices and the NIST library. Results The questionnaire demonstrated high validity, with an item-wise content validity index of 0.95 and a scale-level content validity index of 0.94. Among respondents, 54% reported routine use of Mahabala Tailam, and 45% employed it both internally and externally. Physicians most commonly reported its use in musculoskeletal conditions (89.7%), neurodegenerative disorders (66.1%), and male reproductive health conditions (29.3%). GC–MS analysis identified multiple non-polar phytochemical constituents, including sesquiterpenes (α-cadinol, δ-cadinene, caryophyllene, longifolene), phenylpropanoids (apiol), and fatty acids and their derivatives. Statistical analyses indicated significant associations between physician experience, usage patterns, and physician-reported perceptions of clinical utility. Conclusion This multicenter observational study documents widespread clinical use of Mahabala Tailam and positive physician-reported perceptions of its clinical utility across several traditional indication domains. The identified phytochemical constituents provide biological plausibility for their classical applications. However, as this study is based on physician-reported perceptions and does not assess patient-level outcomes, the findings should be interpreted as hypothesis-generating and supportive of future controlled clinical trials.

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