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

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This multicentre descriptive cross-sectional survey studied prescribing patterns and physician-reported perceptions of clinical utility of the Ayurvedic medicated oil Mahabala Tailam among 303 registered Ayurvedic physicians in India, and also profiled the marketed formulation’s phytochemical composition using GC–MS. Physicians most commonly reported use for musculoskeletal conditions (89.7%) and neurodegenerative disorders (66.1%), with 54% reporting routine use and 45% using it both internally and externally, and statistical analyses linked aspects of physician experience and usage patterns to perceived utility. GC–MS identified multiple non-polar constituents, including sesquiterpenes (e.g., α-cadinol, δ-cadinene, caryophyllene, longifolene), phenylpropanoids (e.g., apiol), and fatty acids/derivatives, which the authors cite as providing biological plausibility. The study limitation is that it relies on physician-reported perceptions and does not assess patient-level outcomes, so the findings are described as hypothesis-generating for future controlled trials. This paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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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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Real-World Multicentre Observational Study and Phytochemical Profiling of Mahabala Tailam: Physician- Reported Usage Patterns and Clinical Perceptions from India | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Real-World Multicentre Observational Study and Phytochemical Profiling of Mahabala Tailam: Physician- Reported Usage Patterns and Clinical Perceptions from India Dr Anoop AK, Dr P.M Varier, Dr Ramesh P. R, Dr Haritha N, Dr Deepak M, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8684241/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version 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. Mahabala Tailam Vatavyadhi GC–MS (Gas Chromatography–Mass Spectrometry) α-Cadinol δ-Cadinene Oligospermia Figures Figure 1 Figure 2 Figure 3 INTRODUCTION Medicated oils ( Tailas ) form a cornerstone of therapeutic interventions in Ayurveda. Their unique ability to incorporate both lipid-soluble and water-soluble phytoconstituents makes them highly versatile for internal and external use.[ 1 ] Mahabala Tailam , a classical formulation described in Bhaishajya Ratnavali (Chap. 28), is traditionally indicated for Vatavyadhi, musculoskeletal injuries, postpartum care, and reproductive system disorders.[ 2 ] The formulation comprises a decoction ( kashaya ) of Bala ( Sida cordifolia ) and Dashamoola , processed with Paya (milk), Tila Taila (sesame oil), and herbal pastes ( kalka ) prepared from approximately 30 drugs. This complex polyherbal matrix reflects Ayurveda’s principle of synergistic action. Table 1 Major ingredients of Mahabala Tailam Kashaya/Decoction Sneha/Fat metabolism Kalka/herbal paste Balamula (Sida cordifolia) Paya (Milk) Jivanti (Leptadenia reticulata) Kasmari (Gmelina arborea) Taila (Sesamum indicum) Kakolidvaya (Withania somnifera (sub.)) Vilva (Aegle marmelos) Dvimeda (Asparagus racemosus (sub.) Patala (Stereospermum colais) Mashaparni (Vigna radiata var. sublobata) Syonaka(Oroxylum indicum) Mudgaparni (Dysolobium pilosu ) Agnimantha (Premna corymbosa) Dvijivaka (Pueraria tuberosa (sub.) Salaparni (Pseudarthria viscida) Madhuyashti (Glycyrrhiza glabra) Prisniparni (Desmodium gangeticum) Saindhava (Rock salt) Brihati (Solanum anguivi) Sarjarasa(Shorea robusta) Nididgdhika (Solanum virginianum) Sarala (Pinus roxburghii) Swadamstra (Tribulus terrestris) Devadaru (Cedrus deodara) Yava (Hordeum vulgare) Manjishta (Rubia cordifolia) Kola (Ziziphus mauritiana) Chandana (Santalum album) Kulatha (Macrotyloma uniflorum) Ela (Elettaria caradamomum) Kalanusari (Trigonella foenum-graceum) Saileya (Parmelia perlata) Patra (Cinnamomum tamala) Tagara (Valeriana jatamansi) Sariba (Hemidesmus indicus) Sathavari (Asparagus racemosus) Asvagandha (Withania somnifera) Satahpushpa (Anethum graveolens) Punarnava (Boerhavia diffusa) Mahabala Tailam is a widely used classical formulation with diverse traditional indications across multiple body systems. In reproductive health, it supports male fertility by enhancing semen quality and aids conception and postpartum recovery in females.[ 2 ] It is traditionally indicated and commonly prescribed for musculoskeletal conditions like osteoarthritis and fractures. Additionally, it plays a significant role in treating vatavyadhi (neuromuscular and neurodegenerative disorders) through both internal and external snehana (oleation) therapies.[ 2 ] Previous phytochemical studies on individual ingredients, such as Sida cordifolia , Withania somnifera , Cedrus deodara , and Tribulus terrestris , suggest the presence of anti-inflammatory, antioxidant, neuroprotective, and reproductive health–modulating compounds. [ 3 – 6 ] Despite its widespread clinical use and established classical indications, there is a lack of systematic, real-world evidence regarding how Ayurvedic physicians across India currently utilize Mahabala Tailam. The existing literature offers limited correlation between physician-reported therapeutic experiences and the phytochemical characteristics of the final formulation. Additionally, classical oils are typically studied either through textual descriptions or laboratory analyses, but seldom through a combined evaluation of usage patterns and chemical profiling. This combined approach is essential for understanding the contemporary relevance and standardization needs of these formulations. The present study addresses this gap by integrating multicentre real-world data on physician usage patterns with phytochemical profiling using GC-MS based analysis of the final formulation, a methodology not previously applied to Mahabala Tailam. This study aims to: Document how Mahabala Tailam is used in routine Ayurvedic clinical practice across multiple centres in India, Identify common indications, modes of administration, and perceived therapeutic benefits. Characterize the phytochemical profile of the marketed formulation. Together, these findings provide a more comprehensive understanding of this classical oil, bridging traditional knowledge, practitioner perspectives, and chemical analysis. MATERIALS AND METHODS Sample details Mahabala tailam was obtained from the product development Department of Arya Vaidya Sala, Kottakkal, Batch Number 217465. The raw drugs for the preparation of Mahabala tailam were authenticated by a botanist in the Quality Assurance Department of Aryavaidya Sala, Kottakkal and deposited in the institutional repository. Study Design A descriptive cross-sectional survey was conducted among 303 Ayurvedic physicians across India. Questionnaire validation : Phase 1- Questionnaire validity was assessed by 12 experts with over 25 years of clinical experience, and Phase 2- content validation was evaluated by 12 experts with over 25 years of clinical experience. Each question was validated for its relevance, clarity, and essentiality. Statistical analyses, including content validity index (CVI) and scale-wise content validity index (SCVI) for questionnaire validation, tests for association, regression analysis, and collinearity diagnostics. The sample size was estimated based on an assumed prevalence of 75% and a precision of 5% and a confidence interval of 95%. Inclusion Criteria Registered Ayurvedic physicians Age 25–80 years Exclusion Criteria Physicians unwilling to participate GC-MS analysis GC/MS analysis of the Mahabala tailam was conducted using an Agilent 6850 System equipped with an HP-5 MS fused silica capillary column (30 m x 0.25 mm, film thickness 0.25 μm) paired with an Agilent 5975C VL-MSD with a Triple-Axis detector under the following conditions: 1 μL of diluted samples (1 mg/ml in hexane, w/v) was injected automatically in splitless mode; helium served as the carrier gas at a constant flow rate of 1 mL/min. The injector temperature was set to 230°C, and the oven temperature was programmed from 60°C to 130°C at 5°C/min, then from 130°C to 270°C at 10°C/min, with a hold at 270°C for 1 minute. Mass spectra were acquired in electron impact (EI) mode at 70 eV; the ion source temperature was 230°C. Spectra were recorded over a 50-500 amu range; the electron multiplier was set to 1460 eV, with a scan rate of 2.96 scans/sec. Retention indices, based on the homologous series C8-C20 n-alkanes, were used to identify chemical constituents [7]. The components were further identified by comparing their mass spectra with the NIST-8 library [8]. The relative percentages of the components were calculated based on the GC-MS peak areas [9]. Statistical Analysis Data were analysed using chi-square tests, Spearman’s correlation, regression analysis, and collinearity diagnostics. Associations between demographic factors, usage patterns, and clinical effectiveness were examined. This study captures physician-reported perceptions and prescribing experiences and does not involve direct patient-level outcome assessment. RESULTS 1. Questionnaire Validation Face validity of the questionnaire was assessed by 12 senior Ayurvedic physicians and was rated as satisfactory, with an overall agreement of 85%. Content validity assessment demonstrated a high item-wise content validity index (I-CVI) of 0.95. The scale-level content validity index (S-CVI) was 0.94, indicating strong overall content validity of the questionnaire. 2. Cross-Sectional Survey Findings 2.1 Demographic Characteristics A total of 303 Ayurvedic physicians participated in the survey. The majority of respondents were aged between 31 and 40 years (50.8%). With respect to educational qualifications, 72.6% held a Bachelor of Ayurveda Medicine and Surgery (BAMS) or Bachelor of Ayurvedic Medicine degree, while 25% possessed postgraduate qualifications. Geographically, 61.7% of respondents were practising in Kerala. Most participants (74%) reported more than 10 years of clinical experience. 2.2 Prescribing and Usage Patterns Among the surveyed physicians, 54% reported routine use of Mahabala Tailam in their clinical practice. Regarding mode of administration, 45% indicated that they prescribed the formulation for both internal and external use, while others reported exclusive internal or external application. The most commonly reported indication categories for prescribing Mahabala Tailam were musculoskeletal conditions (89.7%), neurodegenerative disorders (66.1%), male reproductive health conditions (29.3%), and traumatic conditions (24.4%). 2.3 Physician-Reported Perceptions of Clinical Utility Physicians were asked to rate their perceived clinical utility of Mahabala Tailam based on their routine clinical experience. Of the respondents, 66.3% reported high perceived clinical utility, while 26.4% reported moderate perceived clinical utility. A smaller proportion reported low perceived clinical utility. Statistical analysis demonstrated significant associations (p < 0.05) between physician-reported perceptions of clinical utility and several factors, including type of indication, mode of use, additional observed clinical experiences, and years of clinical practice. 2.4 Condition-Specific Physician-Reported Observations Table 2: Major indications of Mahabala Tailam Sl.No Category Frequency Percentage 1 Use of Mahabala Tailam External purpose 119 39.27 Internal purpose 49 16.17 Both 135 44.55 2 Neurodegenerative disorders Indicated in Neurodegenerative disorders 200 66.1 Not indicated in Neurodegenerative disorders 103 33.9 3 Musculoskeletal disorders Indicated in musculoskeletal disorders 272 89.7 Not indicated in Musculoskeletal disorders 31 10.23 4 Male infertility Indicated in male infertility 89 29.37 Not indicated in male infertility 214 70.62 5 Traumatic conditions Indicated in traumatic conditions 74 24.42 Not indicated in traumatic conditions 229 75.57 Physicians reported various clinical observations associated with the use of Mahabala Tailam across different indication domains. Musculoskeletal conditions: Pain relief was reported by 166 physicians, reduced stiffness by 151 physicians, and improved flexibility by 100 physicians. Neurodegenerative conditions: Among physicians who reported use in Parkinson’s disease, 90 noted perceived reduction in stiffness, and 40 reported perceived improvement in involuntary movements based on their clinical experience. Male reproductive health: Perceived improvement in oligospermia was reported by 55 physicians, while 32 reported perceived improvement in erectile function. Additional observations: Physicians also reported perceived improvement in physical strength during monsoon seasons, relief in trigeminal neuralgia, improvement in facial palsy (notably with nasal administration), and increased hair growth following COVID-19 illness. These observations reflect physician-reported clinical experiences and do not represent patient-level outcome measurements. 2.5 Association Analyses Chi-square analysis revealed a statistically significant association between years of clinical experience and routine use of Mahabala Tailam. Physicians with more than 10 years of experience were more likely to report regular use of the formulation. Spearman’s correlation analysis demonstrated a positive association between clinical experience and physician-reported perceptions of clinical utility. More experienced physicians tended to report higher perceived clinical utility. Regression analysis identified usage frequency, indication category (musculoskeletal, neurodegenerative, and male reproductive health), combined mode of administration, and additional reported observations as significant predictors of physician-reported perceptions of clinical utility. Collinearity diagnostics indicated low multicollinearity among predictor variables. Table 3: chi-square tests Value df P value Number of Valid Cases Pearson Chi-Square 17.579 a 9 .040 303 *2 cells (12.5%) have expected count less than 5. The minimum expected count is 1.85. A statistically significant association was observed between the studied variables (Pearson χ² = 17.579, df = 9, p = 0.040; n = 303). Although 12.5% of cells had expected counts less than five (minimum expected count = 1.85), this proportion was within acceptable limits, supporting the validity of the chi-square test results. Musculoskeletal Conditions and Physician-Reported Clinical Utility Chi-square analysis demonstrated a highly significant association (p = 0.001) between the use of Mahabala Tailam in musculoskeletal conditions and physician-reported perceptions of clinical utility. Neurodegenerative Conditions and Physician-Reported Clinical Utility A highly significant association (p = 0.001) was observed between reported use in neurodegenerative conditions and physician-reported perceptions of clinical utility. Mode of Use and Physician-Reported Clinical Utility A statistically significant association (p = 0.049) was identified between the mode of administration (internal, external, or combined) and physician-reported perceptions of clinical utility. Additional Clinical Observations and Physician-Reported Clinical Utility Chi-square analysis indicated a significant association (p = 0.018) between additional physician-reported clinical observations and perceived clinical utility. The majority of physicians (201; 66.3%) reported high perceived clinical utility, while 80 physicians (26.4%) reported moderate perceived clinical utility. This observational study is reported in accordance with the STROBE guidelines for cross-sectional studies. 3. Phytochemical Profiling GC–MS analysis revealed diverse nonpolar chemical constituents, including Sesquiterpenes, Fatty acids and derivatives, Phenylpropanoids, Alcohols, Ketones and esters in Mahabala Tailam . Sesquiterpenes like longifolene, caryophyllene, α-cadinol, and δ-cadinene were identified in Tailam . Apiol, a major phenylpropanoid, with alcohols hexacosanol and methylhexadecan-1-ol, were also detected. Important Fatty acids and derivatives like oleic acid, trans-13-octadecenoic acid, cis-13-eicosenoic acid were also characterized in Tailam . Various ketones and esters were also recognized in Mahabala Tailam . Table 4: GC-MS compounds analysis results Retention Time Identified Compound 13.9 Coumaran 16.3 7a-Methyl-1,4,5,6,7,7a-hexahydro-2H-inden-2-one 18.3 Longifolene 18.5 Caryophyllene 19.8 α-Cadinol 20.3 δ-Cadinene 21.6 Asarone 21.7 Apiol 22.6 2-Pentadecanone 23.1 2-Methylhexadecan-1-ol 23.9 2-cis-9-Octadecenyloxyethanol 25.5 Oleic Acid 26.1 cis-13-Eicosenoic acid 26.2 17-Pentatriacontene 27.2 trans-13-Octadecenoic acid 27.6 17-Pentatriacontene 27.8 Oleic acid, 3-(octadecyloxy)propyl ester 28.6 n-Hexacosanol 29.9 Oleic acid 3-(octadecyloxy)propyl ester DISCUSSION The present study provides a multicentre overview of real-world prescribing patterns and physician-reported clinical experiences associated with Mahabala Tailam, complemented by phytochemical profiling of the marketed formulation. By integrating practitioner perspectives with GC–MS analysis, this work offers descriptive insights into contemporary Ayurvedic practice while remaining consistent with the observational design of the study. Physician-reported clinical utility and traditional indications Findings from the nationwide survey indicate that Mahabala Tailam is widely prescribed by Ayurvedic physicians, particularly for musculoskeletal conditions, neurodegenerative disorders, and male reproductive health concerns. These patterns of use are consistent with the classical indications described in Bhaishajya Ratnavali , where Mahabala Tailam is recommended for Vatavyadhi , traumatic conditions, and disorders involving musculoskeletal and neuromuscular systems [ 2 , 15 ]. Importantly, the present findings reflect physician-reported perceptions and prescribing experiences rather than patient-level clinical outcomes. Musculoskeletal conditions constituted the most frequently reported indication category. Physicians commonly reported perceived relief in pain, stiffness, and functional limitations based on their routine clinical experience. Such observations are in alignment with the traditional use of medicated oils ( taila kalpana ) in Ayurveda, which are valued for their capacity to deliver lipid-soluble and water-soluble phytoconstituents through internal and external administration [ 1 ]. Similarly, the reported use of Mahabala Tailam in neurodegenerative conditions, including Parkinson’s disease–related symptoms, corresponds with classical Ayurvedic approaches employing snehana therapies for disorders attributed to Vata imbalance [ 2 ]. Phytochemical plausibility supporting traditional use GC–MS analysis of Mahabala Tailam revealed the presence of several non-polar phytochemical constituents, including sesquiterpenes (caryophyllene, longifolene, α-cadinol, δ-cadinene), phenylpropanoids (apiol), and fatty acids and their derivatives. Previous experimental and preclinical studies have demonstrated anti-inflammatory, analgesic, neuroprotective, and reproductive health–modulating properties for several of these compounds, providing biological plausibility for the physician-reported clinical experiences documented in this study. β-Caryophyllene, a major sesquiterpene identified in the formulation, has been shown to possess anti-inflammatory and analgesic properties in experimental models, including studies on arthritis and inflammatory pain [ 11 – 14 ]. α- and β-asarone, also detected in Mahabala Tailam, have been reported to exhibit anti-inflammatory, anti-nociceptive, and neuroprotective effects through modulation of oxidative stress, neuroinflammation, and neurotransmitter pathways in preclinical models [ 16 – 21 ]. Oleic acid, another identified constituent, has demonstrated significant anti-inflammatory activity and immunomodulatory effects in experimental studies, including regulation of NF-κB signaling pathways [ 22 – 25 ]. Additionally, compounds such as α-cadinol and δ-cadinene have been associated with neuroactive and autonomic nervous system–modulating effects, suggesting potential relevance to neurological applications [ 26 – 27 ]. While these findings support pharmacological plausibility, it is essential to emphasize that the presence of bioactive phytochemicals does not establish clinical efficacy of the formulation. Rather, phytochemical profiling complements practitioner-reported observations by generating mechanistic hypotheses that merit further evaluation through controlled experimental and clinical research. Influence of physician experience and prescribing behaviour Statistical analyses revealed significant associations between physician experience, frequency of use, mode of administration, and physician-reported perceptions of clinical utility. More experienced practitioners were more likely to report routine use of Mahabala Tailam and higher perceived clinical utility. This trend may reflect greater familiarity with classical formulations, accumulated clinical experience, and individualized treatment strategies developed over years of practice. Similar observations have been noted in studies examining real-world use of traditional formulations, where practitioner experience plays a critical role in therapeutic decision-making [ 1 – 2 ]. Strengths and limitations A major strength of this study is its multicenter design and inclusion of a large sample of Ayurvedic physicians from diverse practice settings, offering a broad overview of real-world clinical use. The use of a validated questionnaire and integration of phytochemical profiling further enhances the descriptive value of the findings. However, several limitations must be acknowledged. The study is based on physician-reported perceptions and does not involve direct measurement of patient-level outcomes, standardized clinical assessments, or comparator groups. As a cross-sectional observational survey, the study cannot establish clinical effectiveness, efficacy, or causal relationships. Recall bias and subjective interpretation of clinical experiences may also influence responses. Consequently, the findings should be interpreted as descriptive and hypothesis-generating rather than confirmatory. Implications for future research The results underscore the need for well-designed prospective clinical studies to evaluate the safety and efficacy of Mahabala Tailam using standardized outcome measures. Future research may include controlled clinical trials, pharmacological investigations of identified phytochemicals, and studies exploring dose–response relationships and pharmacokinetics. Such efforts would help further integrate classical Ayurvedic knowledge with contemporary evidence-based research frameworks. CONCLUSION This multicentre observational study documents real-world prescribing patterns and physician-reported clinical experiences related to Mahabala Tailam across diverse Ayurvedic practice settings in India. The findings indicate widespread use of the formulation, particularly for musculoskeletal conditions, neurodegenerative disorders, and male reproductive health concerns, in alignment with its classical indications. Phytochemical profiling using GC–MS identified multiple bioactive constituents that provide a pharmacological context and biological plausibility for the traditional applications of Mahabala Tailam. However, as the study is based on physician-reported perceptions and does not include patient-level outcome assessment or comparator groups, the findings cannot establish clinical effectiveness or causal relationships. Overall, the results should be interpreted as descriptive and hypothesis-generating. They support the need for future prospective clinical studies employing standardized outcome measures to further evaluate the safety, efficacy, and therapeutic role of Mahabala Tailam within integrative healthcare frameworks. Declarations Declaration of generative AI and AI-assisted technologies in the writing process: During the preparation of this manuscript, the authors used generative AI-assisted tools for language editing and improving the clarity and readability of the text. The authors carefully reviewed and edited the content generated by these tools and take full responsibility for the scientific accuracy, integrity, and originality of the manuscript. No generative AI tools were used for data analysis, interpretation of results, or generation of figures. Conflict of interest No conflict of interest declared by the authors. Acknowledgments The authors express their gratitude to Mr K. Hari Kumar (Chief Executive Officer), Mrs Ganga R Varier, Chief Finance & Accounts, Ms Vishnupriya K., and all study participants for their support and contributions to this study. Data availability statement The datasets generated and analyzed during the current study are not publicly available but are available from the corresponding author upon reasonable request. Funding Statement: This study did not receive any external funding. Ethical Compliance: All procedures involving human participants adhered to the ethical standards of the institutional and/or national research committee and complied with the 1964 Helsinki Declaration and its later amendments. 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Anti-arthritic and anti-inflammatory activity of β-caryophyllene against Freund’s complete adjuvant induced arthritis in Wistar rats. J. Bone Rep. Recomm. 2015; 1:1–10. https://api.semanticscholar.org/CorpusID:35450137 El-Sheikh S.M., Abd El A.E.-A.F., Galal A.A., El-Sayed R.G., El-Naseery N.I. Anti- arthritic effect of β-caryophyllene and its ameliorative role on methotrexate and/or leflunomide-induced side effects in arthritic rats. Life Sci. 2019;233: 116750. Doi: 10.1016/j.lfs.2019.116750.DOI: 10.1016/j.lfs.2019.116750 Prof.Gyanendra Pandey, editor. Govinda Das Sen. Bhaisajya Ratnavali. (Sanskrit)]. Varanasi: Chaukhamba Sanskrit Series Office 2020; chapter 28,509: 28/34. Aline Aparecida Saldanha, Letícia Vieira, Flávio Martins de Oliveira, et al. Anti-inflammatory and central and peripheral anti-nociceptive activities of α-asarone through the inhibition of TNF-α production, leukocyte recruitment and iNOS expression, and participation of the adenosinergic and opioidergic systems. Inflammopharmacology. 2020 Aug;28(4):1039-1052. doi: 10.1007/s10787-019-00679-1.DOI: 10.1007/s10787-019-00679-1 Mayda Yanik Aquino-Vega, Lorena Rodríguez-Páez, Patricia Arce-Paredes, Víctor G. Hernández-Chávez, Enrique Becerril-Villanueva, Oscar Rojas-Espinosa. The effect of alpha asarone, olive oil, and dexamethasone on collagen-induced arthritis (CIA) in the mouse. Modern Research in Inflammation. Vol.2 No.1(2013), Article ID:28449,12 pages DOI:10.4236/mri.2013.2100. DOI:10.4236/mri.2013.21002 Rengasamy Balakrishnan, Duk-Yeon Cho, In-Su Kim, Sang-Ho Seol, Dong-Kug Choi. Molecular Mechanisms and Therapeutic Potential of α- and β-Asarone in the Treatment of Neurological Disorders. Antioxidants (Basel). 2022 Feb; 11(2): 281. DOI: 10.3390/antiox11020281 Yong-Qi Fang, Zhong-Feng Xue. Chapter 9 - Beta-Asarone Reduces Autophagy in a Dose-Dependent Manner and Interferes with Beclin 1 Function. Autophagy: Cancer, Other Pathologies, Inflammation, Immunity, Infection, and Ageing Volume 7: Role of Autophagy in Therapeutic Applications. https://doi.org/10.1016/B978-0-12-801043-3.00009-1Get rights and content Ranjithkumar Chellian, Vijayapandi Pandy, Zahurin Mohamed. Pharmacology and toxicology of α- and β-Asarone: A review of preclinical evidence. Phytomedicine. Volume 32, 15 August 2017, Pages 41-58. https://doi.org/10.1016/j.phymed.2017.04.003 Byung-Wook Kim, Sushruta Koppula, Hemant Kumar, Ju-Young Park, Il-Woung Kim, Sandeep V. More, In-Su Kim, Sang-Don Han, Si-Kwan Kim, Sung-Hwa Yoon, Dong-Kug Choi. α-Asarone attenuates microglia-mediated neuroinflammation by inhibiting NF kappa B activation and mitigates MPTP-induced behavioural deficits in a mouse model of Parkinson's disease. Neuropharmacology. Volume 97, October 2015, Pages 46-57. DOI: 10.1016/j.neuropharm.2015.04.037 Natháli Schopf Pegoraro, Camila Camponogara, Letícia Cruz, Sara Marchesan Oliveira. Oleic acid exhibits an expressive anti-inflammatory effect in croton oil-induced irritant contact dermatitis without the occurrence of toxicological effects in mice. J Ethnopharmacol. 2021 Mar 1; 267:113486.DOI: 10.1016/j.jep.2020.113486 Santamarina AB, Pisani LP, Baker EJ, Marat AD, Valenzuela CA, Miles EA, Calder PC. Anti-inflammatory effects of oleic acid and the anthocyanin keracyanin alone and in combination: effects on monocyte and macrophage responses and the NF-κB pathway. Food Funct. 2021 Sep 7;12(17):7909-7922. doi: 10.1039/d1fo01304a. Epub 2021 Jul 12. PMID: 34250536. Consuelo Santa-María,Soledad López-Enríquez, Sergio Montserrat-de la Paz, Isabel Geniz 3, María Edith Reyes-Quiroz, Manuela Moreno, Francisca Palomares, Francisco Sobrino and Gonzalo Alba. Update on Anti-Inflammatory Molecular Mechanisms Induced by Oleic Acid. Nutrients 2023, 15(1), 224. Maria Chiara Bruno, Agnese Gagliardi, Antonia Mancuso, Antonella Barone, Martine Tarsitano, Donato Cosco, Maria Chiara Cristiano, Massimo Fresta, Donatella Paolino. Oleic acid-based vesicular nanocarriers for topical delivery of the natural drug thymoquinone: Improvement of anti-inflammatory activity. J Control Release. 2022 Dec; 352:74-86.DOI: 10.3390/nu15010224 Chen CJ, Kumar KJ, Chen YT, Tsao NW, Chien SC, Chang ST, Chu FH, Wang SY. Effect of Hinoki and Meniki Essential Oils on Human Autonomic Nervous System Activity and Mood States. Nat Prod Commun. 2015 Jul;10(7):1305-8. PMID: 26411036. Sattayakhom A, Wichit S, Koomhin P. The Effects of Essential Oils on the Nervous System: A Scoping Review. Molecules. 2023 Apr 27;28(9):3771. doi: 10.3390/molecules28093771. PMID: 37175176; PMCID: PMC10180368.DOI: 10.3390/molecules28093771 Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8684241","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":594283454,"identity":"d6da832f-d968-4709-bfeb-f06958d66dcb","order_by":0,"name":"Dr Anoop AK","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0UlEQVRIiWNgGAWjYDCCA1Bagr0BSBpYkKKFB8QykCBFi0QCmCKsg+/24WcPPlTckZec+fzqhh8FEgz87d0JeLVInkszN5xx5pnhbOmcsps9QIdJnDm7Aa8WgzMMZtK8bYcZ50nnpN3gAWoxkMglpIX9G0iL/TzJM2k3/xCnhQdsS+JsCfZjt4myRfIMT5kk0C/JM3ty2G7LGEjwEPQL3xn2bRLAELOdcfz4s5tv/tjI8bf34tcCBQeAmMcAxOIhRjlMC/sDYlWPglEwCkbBCAMAOBtKJw98GMYAAAAASUVORK5CYII=","orcid":"","institution":"Arya Vaidya Sala","correspondingAuthor":true,"prefix":"Dr","firstName":"Anoop","middleName":"","lastName":"AK","suffix":""},{"id":594283455,"identity":"1ffa3a6c-5e9f-4fea-b02a-5bd9dee19ff0","order_by":1,"name":"Dr P.M Varier","email":"","orcid":"","institution":"Arya Vaidya Sala","correspondingAuthor":false,"prefix":"Dr","firstName":"P.M","middleName":"","lastName":"Varier","suffix":""},{"id":594283458,"identity":"3e944313-7294-4929-82ce-25c48d05dd10","order_by":2,"name":"Dr Ramesh P. R","email":"","orcid":"","institution":"Arya Vaidya Sala","correspondingAuthor":false,"prefix":"Dr","firstName":"Ramesh","middleName":"P.","lastName":"R","suffix":""},{"id":594283460,"identity":"11352a5a-2218-4b74-8d71-3a916fa645b1","order_by":3,"name":"Dr Haritha N","email":"","orcid":"","institution":"Arya Vaidya Sala","correspondingAuthor":false,"prefix":"Dr","firstName":"Haritha","middleName":"","lastName":"N","suffix":""},{"id":594283462,"identity":"38ed4cb8-d596-4f4b-9893-ea9faf7b3cc9","order_by":4,"name":"Dr Deepak M","email":"","orcid":"","institution":"Arya Vaidya Sala","correspondingAuthor":false,"prefix":"Dr","firstName":"Deepak","middleName":"","lastName":"M","suffix":""},{"id":594283464,"identity":"c7455613-907a-4b90-8522-17bf252c79d5","order_by":5,"name":"Dr Arjun M K","email":"","orcid":"","institution":"Arya Vaidya Sala","correspondingAuthor":false,"prefix":"Dr","firstName":"Arjun","middleName":"M","lastName":"K","suffix":""},{"id":594283465,"identity":"fea9632a-03ea-4644-9c7a-b944a86faa78","order_by":6,"name":"Venugopalan P","email":"","orcid":"","institution":"Arya Vaidya Sala","correspondingAuthor":false,"prefix":"","firstName":"Venugopalan","middleName":"","lastName":"P","suffix":""}],"badges":[],"createdAt":"2026-01-24 06:24:21","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8684241/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8684241/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":103212013,"identity":"4aea861f-18a0-4956-a395-1491b2bb7f67","added_by":"auto","created_at":"2026-02-23 08:49:26","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":99322,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePhysician-reported perceived clinical utility of Mahabala Tailam\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e[Physicians rated perceived clinical utility based on their overall clinical experience rather than objective outcome measures.]\u003c/em\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8684241/v1/79ddad5d2a7c10a5b3aa6284.png"},{"id":103212015,"identity":"9d363cbc-4147-45ec-80f2-3fddac1c5a3f","added_by":"auto","created_at":"2026-02-23 08:49:26","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":162766,"visible":true,"origin":"","legend":"\u003cp\u003eTotal Ion Chromatogram (GC–MS) of Mahabala Tailam Sample\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8684241/v1/8c40271d3c35c25cb48f8f05.png"},{"id":103212014,"identity":"1b3a4f6b-017a-4ba5-9bcf-dfaf67dc48a7","added_by":"auto","created_at":"2026-02-23 08:49:26","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":40519,"visible":true,"origin":"","legend":"\u003cp\u003eCaryophyllene, Asarone, Oleic Acid\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-8684241/v1/04a4000b7484ed5e5640ea13.png"},{"id":103505538,"identity":"7d87dd25-9e5e-41d2-9e99-1ea84d23e648","added_by":"auto","created_at":"2026-02-26 13:31:40","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1280864,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8684241/v1/196881b5-cb48-40d9-afc2-929e6df767a8.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eReal-World Multicentre Observational Study and Phytochemical Profiling of Mahabala Tailam: Physician- Reported Usage Patterns and Clinical Perceptions from India \u003c/p\u003e","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eMedicated oils (\u003cem\u003eTailas\u003c/em\u003e) form a cornerstone of therapeutic interventions in Ayurveda. Their unique ability to incorporate both lipid-soluble and water-soluble phytoconstituents makes them highly versatile for internal and external use.[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] \u003cem\u003eMahabala Tailam\u003c/em\u003e, a classical formulation described in \u003cem\u003eBhaishajya Ratnavali\u003c/em\u003e (Chap.\u0026nbsp;28), is traditionally indicated for Vatavyadhi, musculoskeletal injuries, postpartum care, and reproductive system disorders.[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eThe formulation comprises a decoction (\u003cem\u003ekashaya\u003c/em\u003e) of \u003cem\u003eBala\u003c/em\u003e (\u003cem\u003eSida cordifolia\u003c/em\u003e) and \u003cem\u003eDashamoola\u003c/em\u003e, processed with \u003cem\u003ePaya\u003c/em\u003e (milk), \u003cem\u003eTila Taila\u003c/em\u003e (sesame oil), and herbal pastes (\u003cem\u003ekalka\u003c/em\u003e) prepared from approximately 30 drugs. This complex polyherbal matrix reflects Ayurveda\u0026rsquo;s principle of synergistic action.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eMajor ingredients of Mahabala Tailam\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eKashaya/Decoction\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSneha/Fat metabolism\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eKalka/herbal paste\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eBalamula (Sida cordifolia)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003ePaya (Milk)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eJivanti (Leptadenia reticulata)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eKasmari (Gmelina arborea)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eTaila\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Sesamum indicum)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eKakolidvaya\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Withania somnifera (sub.))\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eVilva (Aegle marmelos)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eDvimeda\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Asparagus racemosus (sub.)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePatala\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Stereospermum colais)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eMashaparni\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Vigna radiata var. sublobata)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eSyonaka(Oroxylum indicum)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eMudgaparni\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Dysolobium pilosu\u003c/em\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eAgnimantha\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Premna corymbosa)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eDvijivaka\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Pueraria tuberosa (sub.)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eSalaparni\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Pseudarthria viscida)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eMadhuyashti (Glycyrrhiza glabra)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePrisniparni\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Desmodium gangeticum)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eSaindhava (Rock salt)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eBrihati\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Solanum anguivi)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eSarjarasa(Shorea robusta)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eNididgdhika\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Solanum virginianum)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eSarala\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Pinus roxburghii)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eSwadamstra\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Tribulus terrestris)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eDevadaru\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Cedrus deodara)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eYava (Hordeum vulgare)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eManjishta (Rubia cordifolia)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eKola (Ziziphus mauritiana)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eChandana (Santalum album)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eKulatha\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Macrotyloma uniflorum)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eEla (Elettaria caradamomum)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eKalanusari\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Trigonella foenum-graceum)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eSaileya\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Parmelia perlata)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003ePatra\u003c/em\u003e\u003c/p\u003e \u003cp\u003e\u003cem\u003e(Cinnamomum tamala)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eTagara (Valeriana jatamansi)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eSariba (Hemidesmus indicus)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eSathavari (Asparagus racemosus)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eAsvagandha (Withania somnifera)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eSatahpushpa (Anethum graveolens)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003ePunarnava (Boerhavia diffusa)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eMahabala Tailam is a widely used classical formulation with diverse traditional indications across multiple body systems. In reproductive health, it supports male fertility by enhancing semen quality and aids conception and postpartum recovery in females.[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] It is traditionally indicated and commonly prescribed for musculoskeletal conditions like osteoarthritis and fractures. Additionally, it plays a significant role in treating vatavyadhi (neuromuscular and neurodegenerative disorders) through both internal and external snehana (oleation) therapies.[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] Previous phytochemical studies on individual ingredients, such as \u003cem\u003eSida cordifolia\u003c/em\u003e, \u003cem\u003eWithania somnifera\u003c/em\u003e, \u003cem\u003eCedrus deodara\u003c/em\u003e, and \u003cem\u003eTribulus terrestris\u003c/em\u003e, suggest the presence of anti-inflammatory, antioxidant, neuroprotective, and reproductive health\u0026ndash;modulating compounds. [\u003cspan additionalcitationids=\"CR4 CR5\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eDespite its widespread clinical use and established classical indications, there is a lack of systematic, real-world evidence regarding how Ayurvedic physicians across India currently utilize Mahabala Tailam. The existing literature offers limited correlation between physician-reported therapeutic experiences and the phytochemical characteristics of the final formulation. Additionally, classical oils are typically studied either through textual descriptions or laboratory analyses, but seldom through a combined evaluation of usage patterns and chemical profiling. This combined approach is essential for understanding the contemporary relevance and standardization needs of these formulations.\u003c/p\u003e \u003cp\u003eThe present study addresses this gap by integrating multicentre real-world data on physician usage patterns with phytochemical profiling using GC-MS based analysis of the final formulation, a methodology not previously applied to Mahabala Tailam.\u003c/p\u003e \u003cp\u003eThis study aims to:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eDocument how Mahabala Tailam is used in routine Ayurvedic clinical practice across multiple centres in India,\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eIdentify common indications, modes of administration, and perceived therapeutic benefits.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eCharacterize the phytochemical profile of the marketed formulation.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eTogether, these findings provide a more comprehensive understanding of this classical oil, bridging traditional knowledge, practitioner perspectives, and chemical analysis.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cp\u003e\u003cstrong\u003eSample details\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMahabala tailam was obtained from the product development Department of Arya Vaidya Sala, Kottakkal, Batch Number 217465. The raw drugs for the preparation of Mahabala tailam were authenticated by a botanist in the Quality Assurance Department of Aryavaidya Sala, Kottakkal and deposited in the institutional repository.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA descriptive cross-sectional survey was conducted among 303 Ayurvedic physicians across India.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuestionnaire validation\u003c/strong\u003e: Phase 1- Questionnaire validity was assessed by 12 experts with over 25 years of clinical experience, and Phase 2- content validation was evaluated by 12 experts with over 25 years of clinical experience. Each question was validated for its relevance, clarity, and essentiality. Statistical analyses, including content validity index (CVI) and scale-wise content validity index (SCVI) for questionnaire validation, tests for association, regression analysis, and collinearity diagnostics. The sample size was estimated based on an assumed prevalence of 75% and a precision of 5% and a confidence interval of 95%.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003eRegistered Ayurvedic physicians\u003c/li\u003e\n \u003cli\u003eAge 25\u0026ndash;80 years\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003ePhysicians unwilling to participate\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eGC-MS analysis\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGC/MS analysis of the Mahabala tailam was conducted using an Agilent 6850 System equipped with an HP-5 MS fused silica capillary column (30 m x 0.25 mm, film thickness 0.25 \u0026mu;m) paired with an Agilent 5975C VL-MSD with a Triple-Axis detector under the following conditions: 1 \u0026mu;L of diluted samples (1 mg/ml in hexane, w/v) was injected automatically in splitless mode; helium served as the carrier gas at a constant flow rate of 1 mL/min. The injector temperature was set to 230\u0026deg;C, and the oven temperature was programmed from 60\u0026deg;C to 130\u0026deg;C at 5\u0026deg;C/min, then from 130\u0026deg;C to 270\u0026deg;C at 10\u0026deg;C/min, with a hold at 270\u0026deg;C for 1 minute. Mass spectra were acquired in electron impact (EI) mode at 70 eV; the ion source temperature was 230\u0026deg;C. Spectra were recorded over a 50-500 amu range; the electron multiplier was set to 1460 eV, with a scan rate of 2.96 scans/sec. Retention indices, based on the homologous series C8-C20 n-alkanes, were used to identify chemical constituents [7]. The components were further identified by comparing their mass spectra with the NIST-8 library [8]. The relative percentages of the components were calculated based on the GC-MS peak areas [9].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData were analysed using chi-square tests, Spearman\u0026rsquo;s correlation, regression analysis, and collinearity diagnostics. Associations between demographic factors, usage patterns, and clinical effectiveness were examined.\u003c/p\u003e\n\u003cp\u003eThis study captures physician-reported perceptions and prescribing experiences and does not involve direct patient-level outcome assessment.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003e\u003cstrong\u003e1. Questionnaire Validation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFace validity of the questionnaire was assessed by 12 senior Ayurvedic physicians and was rated as satisfactory, with an overall agreement of 85%. Content validity assessment demonstrated a high item-wise content validity index (I-CVI) of 0.95. The scale-level content validity index (S-CVI) was 0.94, indicating strong overall content validity of the questionnaire.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2. Cross-Sectional Survey Findings\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e2.1 Demographic Characteristics\u003c/p\u003e\n\u003cp\u003eA total of 303 Ayurvedic physicians participated in the survey. The majority of respondents were aged between 31 and 40 years (50.8%). With respect to educational qualifications, 72.6% held a Bachelor of Ayurveda Medicine and Surgery (BAMS) or Bachelor of Ayurvedic Medicine degree, while 25% possessed postgraduate qualifications. Geographically, 61.7% of respondents were practising in Kerala. Most participants (74%) reported more than 10 years of clinical experience.\u003c/p\u003e\n\u003cp\u003e2.2 Prescribing and Usage Patterns\u003c/p\u003e\n\u003cp\u003eAmong the surveyed physicians, 54% reported routine use of Mahabala Tailam in their clinical practice. Regarding mode of administration, 45% indicated that they prescribed the formulation for both internal and external use, while others reported exclusive internal or external application.\u003c/p\u003e\n\u003cp\u003eThe most commonly reported indication categories for prescribing Mahabala Tailam were musculoskeletal conditions (89.7%), neurodegenerative disorders (66.1%), male reproductive health conditions (29.3%), and traumatic conditions (24.4%).\u003c/p\u003e\n\u003cp\u003e2.3 Physician-Reported Perceptions of Clinical Utility\u003c/p\u003e\n\u003cp\u003ePhysicians were asked to rate their perceived clinical utility of Mahabala Tailam based on their routine clinical experience. Of the respondents, 66.3% reported high perceived clinical utility, while 26.4% reported moderate perceived clinical utility. A smaller proportion reported low perceived clinical utility.\u003c/p\u003e\n\u003cp\u003eStatistical analysis demonstrated significant associations (p \u0026lt; 0.05) between physician-reported perceptions of clinical utility and several factors, including type of indication, mode of use, additional observed clinical experiences, and years of clinical practice.\u003c/p\u003e\n\u003cp\u003e2.4 Condition-Specific Physician-Reported Observations\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2: Major indications of Mahabala Tailam\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"626\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSl.No\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eCategory\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eFrequency\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePercentage\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eUse of Mahabala Tailam\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eExternal\u0026nbsp;purpose\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e119\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e39.27\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eInternal purpose\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e49\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e16.17\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eBoth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e135\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e44.55\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eNeurodegenerative disorders\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eIndicated in Neurodegenerative disorders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e200\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e66.1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eNot indicated in Neurodegenerative disorders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e103\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e33.9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eMusculoskeletal disorders\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eIndicated in\u0026nbsp;musculoskeletal disorders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e272\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e89.7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eNot indicated in Musculoskeletal disorders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e31\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e10.23\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eMale infertility\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eIndicated in male infertility\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e89\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29.37\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eNot indicated in male infertility\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e214\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e70.62\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eTraumatic conditions\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eIndicated in traumatic conditions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e74\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e24.42\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eNot indicated in traumatic conditions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e229\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e75.57\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ePhysicians reported various clinical observations associated with the use of Mahabala Tailam across different indication domains.\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003eMusculoskeletal conditions: Pain relief was reported by 166 physicians, reduced stiffness by 151 physicians, and improved flexibility by 100 physicians.\u003c/li\u003e\n \u003cli\u003eNeurodegenerative conditions: Among physicians who reported use in Parkinson\u0026rsquo;s disease, 90 noted perceived reduction in stiffness, and 40 reported perceived improvement in involuntary movements based on their clinical experience.\u003c/li\u003e\n \u003cli\u003eMale reproductive health: Perceived improvement in oligospermia was reported by 55 physicians, while 32 reported perceived improvement in erectile function.\u003c/li\u003e\n \u003cli\u003eAdditional observations: Physicians also reported perceived improvement in physical strength during monsoon seasons, relief in trigeminal neuralgia, improvement in facial palsy (notably with nasal administration), and increased hair growth following COVID-19 illness.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThese observations reflect physician-reported clinical experiences and do not represent patient-level outcome measurements.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5 Association Analyses\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eChi-square analysis revealed a statistically significant association between years of clinical experience and routine use of Mahabala Tailam. Physicians with more than 10 years of experience were more likely to report regular use of the formulation.\u003c/p\u003e\n\u003cp\u003eSpearman\u0026rsquo;s correlation analysis demonstrated a positive association between clinical experience and physician-reported perceptions of clinical utility. More experienced physicians tended to report higher perceived clinical utility.\u003c/p\u003e\n\u003cp\u003eRegression analysis identified usage frequency, indication category (musculoskeletal, neurodegenerative, and male reproductive health), combined mode of administration, and additional reported observations as significant predictors of physician-reported perceptions of clinical utility. Collinearity diagnostics indicated low multicollinearity among predictor variables.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 3: chi-square tests\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eValue\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003edf\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003eNumber of Valid Cases\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003ePearson Chi-Square\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003e17.579\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003e.040\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 125px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e303\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*2 cells (12.5%) have expected count less than 5. The minimum expected count is 1.85.\u003c/p\u003e\n\u003cp\u003eA statistically significant association was observed between the studied variables (Pearson \u0026chi;\u0026sup2; = 17.579, df = 9, p = 0.040; n = 303). Although 12.5% of cells had expected counts less than five (minimum expected count = 1.85), this proportion was within acceptable limits, supporting the validity of the chi-square test results.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMusculoskeletal Conditions and Physician-Reported Clinical Utility\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eChi-square analysis demonstrated a highly significant association (p = 0.001) between the use of Mahabala Tailam in musculoskeletal conditions and physician-reported perceptions of clinical utility.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNeurodegenerative Conditions and Physician-Reported Clinical Utility\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA highly significant association (p = 0.001) was observed between reported use in neurodegenerative conditions and physician-reported perceptions of clinical utility.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMode of Use and Physician-Reported Clinical Utility\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA statistically significant association (p = 0.049) was identified between the mode of administration (internal, external, or combined) and physician-reported perceptions of clinical utility.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdditional Clinical Observations and Physician-Reported Clinical Utility\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eChi-square analysis indicated a significant association (p = 0.018) between additional physician-reported clinical observations and perceived clinical utility.\u003c/p\u003e\n\u003cp\u003eThe majority of physicians (201; 66.3%) reported high perceived clinical utility, while 80 physicians (26.4%) reported moderate perceived clinical utility.\u003c/p\u003e\n\u003cp\u003eThis observational study is reported in accordance with the STROBE guidelines for cross-sectional studies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3. Phytochemical Profiling\u003c/strong\u003e\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003eGC\u0026ndash;MS analysis revealed diverse nonpolar chemical constituents, including Sesquiterpenes, Fatty acids and derivatives, Phenylpropanoids, Alcohols, Ketones and esters in \u003cem\u003eMahabala Tailam\u003c/em\u003e. Sesquiterpenes like longifolene, caryophyllene, \u0026alpha;-cadinol, and \u0026delta;-cadinene were identified in \u003cem\u003eTailam\u003c/em\u003e. Apiol, a major phenylpropanoid, with alcohols \u003cstrong\u003ehexacosanol\u003c/strong\u003e and methylhexadecan-1-ol, were also detected. Important Fatty acids and derivatives like oleic acid, trans-13-octadecenoic acid, cis-13-eicosenoic acid were also characterized in \u003cem\u003eTailam\u003c/em\u003e. \u0026nbsp;Various ketones and esters were also recognized in \u003cem\u003eMahabala Tailam\u003c/em\u003e.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eTable 4: GC-MS compounds analysis results\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"590\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRetention Time\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eIdentified Compound\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e13.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eCoumaran\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e16.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7a-Methyl-1,4,5,6,7,7a-hexahydro-2H-inden-2-one\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e18.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eLongifolene\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e18.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eCaryophyllene\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e19.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026alpha;-Cadinol\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e20.3 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026delta;-Cadinene\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e21.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAsarone\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e21.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eApiol\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e22.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2-Pentadecanone\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e23.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2-Methylhexadecan-1-ol\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e23.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2-cis-9-Octadecenyloxyethanol\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e25.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eOleic Acid\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e26.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ecis-13-Eicosenoic acid\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e26.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e17-Pentatriacontene\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e27.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003etrans-13-Octadecenoic acid\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e27.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e17-Pentatriacontene\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e27.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eOleic acid, 3-(octadecyloxy)propyl ester\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e28.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003en-Hexacosanol\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eOleic acid 3-(octadecyloxy)propyl ester\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe present study provides a multicentre overview of real-world prescribing patterns and physician-reported clinical experiences associated with Mahabala Tailam, complemented by phytochemical profiling of the marketed formulation. By integrating practitioner perspectives with GC\u0026ndash;MS analysis, this work offers descriptive insights into contemporary Ayurvedic practice while remaining consistent with the observational design of the study.\u003c/p\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003ePhysician-reported clinical utility and traditional indications\u003c/h2\u003e \u003cp\u003eFindings from the nationwide survey indicate that Mahabala Tailam is widely prescribed by Ayurvedic physicians, particularly for musculoskeletal conditions, neurodegenerative disorders, and male reproductive health concerns. These patterns of use are consistent with the classical indications described in \u003cem\u003eBhaishajya Ratnavali\u003c/em\u003e, where Mahabala Tailam is recommended for \u003cem\u003eVatavyadhi\u003c/em\u003e, traumatic conditions, and disorders involving musculoskeletal and neuromuscular systems [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Importantly, the present findings reflect physician-reported perceptions and prescribing experiences rather than patient-level clinical outcomes.\u003c/p\u003e \u003cp\u003eMusculoskeletal conditions constituted the most frequently reported indication category. Physicians commonly reported perceived relief in pain, stiffness, and functional limitations based on their routine clinical experience. Such observations are in alignment with the traditional use of medicated oils (\u003cem\u003etaila kalpana\u003c/em\u003e) in Ayurveda, which are valued for their capacity to deliver lipid-soluble and water-soluble phytoconstituents through internal and external administration [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Similarly, the reported use of Mahabala Tailam in neurodegenerative conditions, including Parkinson\u0026rsquo;s disease\u0026ndash;related symptoms, corresponds with classical Ayurvedic approaches employing \u003cem\u003esnehana\u003c/em\u003e therapies for disorders attributed to \u003cem\u003eVata\u003c/em\u003e imbalance [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003ePhytochemical plausibility supporting traditional use\u003c/h2\u003e \u003cp\u003eGC\u0026ndash;MS analysis of Mahabala Tailam revealed the presence of several non-polar phytochemical constituents, including sesquiterpenes (caryophyllene, longifolene, α-cadinol, δ-cadinene), phenylpropanoids (apiol), and fatty acids and their derivatives. Previous experimental and preclinical studies have demonstrated anti-inflammatory, analgesic, neuroprotective, and reproductive health\u0026ndash;modulating properties for several of these compounds, providing biological plausibility for the physician-reported clinical experiences documented in this study.\u003c/p\u003e \u003cp\u003eβ-Caryophyllene, a major sesquiterpene identified in the formulation, has been shown to possess anti-inflammatory and analgesic properties in experimental models, including studies on arthritis and inflammatory pain [\u003cspan additionalcitationids=\"CR12 CR13\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. α- and β-asarone, also detected in Mahabala Tailam, have been reported to exhibit anti-inflammatory, anti-nociceptive, and neuroprotective effects through modulation of oxidative stress, neuroinflammation, and neurotransmitter pathways in preclinical models [\u003cspan additionalcitationids=\"CR17 CR18 CR19 CR20\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Oleic acid, another identified constituent, has demonstrated significant anti-inflammatory activity and immunomodulatory effects in experimental studies, including regulation of NF-κB signaling pathways [\u003cspan additionalcitationids=\"CR23 CR24\" citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Additionally, compounds such as α-cadinol and δ-cadinene have been associated with neuroactive and autonomic nervous system\u0026ndash;modulating effects, suggesting potential relevance to neurological applications [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eWhile these findings support pharmacological plausibility, it is essential to emphasize that the presence of bioactive phytochemicals does not establish clinical efficacy of the formulation. Rather, phytochemical profiling complements practitioner-reported observations by generating mechanistic hypotheses that merit further evaluation through controlled experimental and clinical research.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eInfluence of physician experience and prescribing behaviour\u003c/h2\u003e \u003cp\u003eStatistical analyses revealed significant associations between physician experience, frequency of use, mode of administration, and physician-reported perceptions of clinical utility. More experienced practitioners were more likely to report routine use of Mahabala Tailam and higher perceived clinical utility. This trend may reflect greater familiarity with classical formulations, accumulated clinical experience, and individualized treatment strategies developed over years of practice. Similar observations have been noted in studies examining real-world use of traditional formulations, where practitioner experience plays a critical role in therapeutic decision-making [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eStrengths and limitations\u003c/h2\u003e \u003cp\u003eA major strength of this study is its multicenter design and inclusion of a large sample of Ayurvedic physicians from diverse practice settings, offering a broad overview of real-world clinical use. The use of a validated questionnaire and integration of phytochemical profiling further enhances the descriptive value of the findings.\u003c/p\u003e \u003cp\u003eHowever, several limitations must be acknowledged. The study is based on physician-reported perceptions and does not involve direct measurement of patient-level outcomes, standardized clinical assessments, or comparator groups. As a cross-sectional observational survey, the study cannot establish clinical effectiveness, efficacy, or causal relationships. Recall bias and subjective interpretation of clinical experiences may also influence responses. Consequently, the findings should be interpreted as descriptive and hypothesis-generating rather than confirmatory.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eImplications for future research\u003c/h2\u003e \u003cp\u003eThe results underscore the need for well-designed prospective clinical studies to evaluate the safety and efficacy of Mahabala Tailam using standardized outcome measures. Future research may include controlled clinical trials, pharmacological investigations of identified phytochemicals, and studies exploring dose\u0026ndash;response relationships and pharmacokinetics. Such efforts would help further integrate classical Ayurvedic knowledge with contemporary evidence-based research frameworks.\u003c/p\u003e \u003c/div\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThis multicentre observational study documents real-world prescribing patterns and physician-reported clinical experiences related to Mahabala Tailam across diverse Ayurvedic practice settings in India. The findings indicate widespread use of the formulation, particularly for musculoskeletal conditions, neurodegenerative disorders, and male reproductive health concerns, in alignment with its classical indications.\u003c/p\u003e \u003cp\u003ePhytochemical profiling using GC\u0026ndash;MS identified multiple bioactive constituents that provide a pharmacological context and biological plausibility for the traditional applications of Mahabala Tailam. However, as the study is based on physician-reported perceptions and does not include patient-level outcome assessment or comparator groups, the findings cannot establish clinical effectiveness or causal relationships.\u003c/p\u003e \u003cp\u003eOverall, the results should be interpreted as descriptive and hypothesis-generating. They support the need for future prospective clinical studies employing standardized outcome measures to further evaluate the safety, efficacy, and therapeutic role of Mahabala Tailam within integrative healthcare frameworks.\u003c/p\u003e "},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eDeclaration of generative AI and AI-assisted technologies in the writing process:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDuring the preparation of this manuscript, the authors used generative AI-assisted tools for language editing and improving the clarity and readability of the text. The authors carefully reviewed and edited the content generated by these tools and take full responsibility for the scientific accuracy, integrity, and originality of the manuscript. No generative AI tools were used for data analysis, interpretation of results, or generation of figures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo conflict of interest declared by the authors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors express their gratitude to Mr K. Hari Kumar (Chief Executive Officer), Mrs Ganga R Varier, Chief Finance \u0026amp; Accounts, \u0026nbsp; Ms Vishnupriya K., and all study participants for their support and contributions to this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analyzed during the current study are not publicly available but are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding Statement:\u003c/strong\u003e This study did not receive any external funding.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Compliance:\u003c/strong\u003e All procedures involving human participants adhered to the ethical standards of the institutional and/or national research committee and complied with the 1964 Helsinki Declaration and its later amendments. The study protocol received approval from the Institutional Ethics Committee of Arya Vaidya Sala, Kottakkal (IEC No. AVS/IEC/CC4/09/24).\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eKumar A, Gupta A, Dixit P. Ayurvedic thaila kalpana: A review. World Journal of Pharmaceutical and Medical Research. 2021;7(12):160-162. https://www.wjpmr.com/download/article/89102021/1637231572.pdf \u003c/li\u003e\n\u003cli\u003eGovinda Das Sen. Bhaishajya Ratnavali. Pandey G, editor. Varanasi: Chaukhamba Sanskrit Series Office; 2020. Chapter 28.\u003c/li\u003e\n\u003cli\u003eSwathy SS, Panicker S, Nithya RS, Anuja MM, Rejitha S, Indira M. Antiperoxidative and antiinflammatory effect of \u003cem\u003eSida cordifolia\u003c/em\u003e Linn. on quinolinic acid-induced neurotoxicity. Neurochem Res. 2010;35(9):1361-7. DOI: 10.1007/s11064-010-0192-5\u003c/li\u003e\n\u003cli\u003eAhmad MK, Mahdi AA, Shukla KK, Islam N, Rajender S, Madhukar D, et al. \u003cem\u003eWithania somnifera\u003c/em\u003e improves semen quality by regulating reproductive hormone levels and oxidative stress in seminal plasma of infertile males. Fertil Steril. 2010;94(3):989-96. DOI: 10.1016/j.fertnstert.2009.04.046\u003c/li\u003e\n\u003cli\u003eBisht A, Jain S, Misra A, Dwivedi J, Paliwal S, Sharma S. \u003cem\u003eCedrus deodara\u003c/em\u003e (Roxb. ex D.Don) G.Don: A review of traditional use, phytochemical composition and pharmacology. J Ethnopharmacol. 2021;279: 114361. DOI: 10.1016/j.jep.2021.114361\u003c/li\u003e\n\u003cli\u003eSellandi TM, Thakar AB, Baghel MS. Clinical study of \u003cem\u003eTribulus terrestris\u003c/em\u003e Linn. in oligozoospermia: A double-blind study. Ayu. 2012;33(3):356-64. DOI: 10.4103/0974-8520.108822\u003c/li\u003e\n\u003cli\u003eVan Den Dool, H.; Kratz, P. D. 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Anti-arthritic and anti-inflammatory activity of \u0026beta;-caryophyllene against Freund\u0026rsquo;s complete adjuvant induced arthritis in Wistar rats. J. Bone Rep. Recomm. 2015; 1:1\u0026ndash;10. https://api.semanticscholar.org/CorpusID:35450137\u003c/li\u003e\n\u003cli\u003eEl-Sheikh S.M., Abd El A.E.-A.F., Galal A.A., El-Sayed R.G., El-Naseery N.I. Anti- arthritic effect of \u0026beta;-caryophyllene and its ameliorative role on methotrexate and/or leflunomide-induced side effects in arthritic rats. Life Sci. 2019;233: 116750. Doi: 10.1016/j.lfs.2019.116750.DOI: 10.1016/j.lfs.2019.116750\u003c/li\u003e\n\u003cli\u003eProf.Gyanendra Pandey, editor. Govinda Das Sen. Bhaisajya Ratnavali. (Sanskrit)]. Varanasi: Chaukhamba Sanskrit Series Office 2020; chapter 28,509: 28/34.\u003c/li\u003e\n\u003cli\u003eAline Aparecida Saldanha, Let\u0026iacute;cia Vieira, Fl\u0026aacute;vio Martins de Oliveira, et al. Anti-inflammatory and central and peripheral anti-nociceptive activities of \u0026alpha;-asarone through the inhibition of TNF-\u0026alpha; production, leukocyte recruitment and iNOS expression, and participation of the adenosinergic and opioidergic systems. Inflammopharmacology. 2020 Aug;28(4):1039-1052. doi: 10.1007/s10787-019-00679-1.DOI: 10.1007/s10787-019-00679-1\u003c/li\u003e\n\u003cli\u003eMayda Yanik Aquino-Vega, Lorena Rodr\u0026iacute;guez-P\u0026aacute;ez, Patricia Arce-Paredes, V\u0026iacute;ctor G. Hern\u0026aacute;ndez-Ch\u0026aacute;vez, Enrique Becerril-Villanueva, Oscar Rojas-Espinosa. The effect of alpha asarone, olive oil, and dexamethasone on collagen-induced arthritis (CIA) in the mouse. Modern Research in Inflammation. Vol.2 No.1(2013), Article ID:28449,12 pages DOI:10.4236/mri.2013.2100. DOI:10.4236/mri.2013.21002 \u003c/li\u003e\n\u003cli\u003eRengasamy Balakrishnan, Duk-Yeon Cho, In-Su Kim, Sang-Ho Seol, Dong-Kug Choi. Molecular Mechanisms and Therapeutic Potential of \u0026alpha;- and \u0026beta;-Asarone in the Treatment of Neurological Disorders. Antioxidants (Basel). 2022 Feb; 11(2): 281. DOI: 10.3390/antiox11020281 \u003c/li\u003e\n\u003cli\u003eYong-Qi Fang, Zhong-Feng Xue. Chapter 9 - Beta-Asarone Reduces Autophagy in a Dose-Dependent Manner and Interferes with Beclin 1 Function. Autophagy: Cancer, Other Pathologies, Inflammation, Immunity, Infection, and Ageing Volume 7: Role of Autophagy in Therapeutic Applications. https://doi.org/10.1016/B978-0-12-801043-3.00009-1Get rights and content\u003c/li\u003e\n\u003cli\u003eRanjithkumar Chellian, Vijayapandi Pandy, Zahurin Mohamed. Pharmacology and toxicology of \u0026alpha;- and \u0026beta;-Asarone: A review of preclinical evidence. Phytomedicine. Volume 32, 15 August 2017, Pages 41-58. https://doi.org/10.1016/j.phymed.2017.04.003\u003c/li\u003e\n\u003cli\u003eByung-Wook Kim, Sushruta Koppula, Hemant Kumar, Ju-Young Park, Il-Woung Kim, Sandeep V. More, In-Su Kim, Sang-Don Han, Si-Kwan Kim, Sung-Hwa Yoon, Dong-Kug Choi. \u0026alpha;-Asarone attenuates microglia-mediated neuroinflammation by inhibiting NF kappa B activation and mitigates MPTP-induced behavioural deficits in a mouse model of Parkinson\u0026apos;s disease. Neuropharmacology. Volume 97, October 2015, Pages 46-57. DOI: 10.1016/j.neuropharm.2015.04.037\u003c/li\u003e\n\u003cli\u003eNath\u0026aacute;li Schopf Pegoraro, Camila Camponogara, Let\u0026iacute;cia Cruz, Sara Marchesan Oliveira. Oleic acid exhibits an expressive anti-inflammatory effect in croton oil-induced irritant contact dermatitis without the occurrence of toxicological effects in mice. J Ethnopharmacol. 2021 Mar 1; 267:113486.DOI: 10.1016/j.jep.2020.113486\u003c/li\u003e\n\u003cli\u003eSantamarina AB, Pisani LP, Baker EJ, Marat AD, Valenzuela CA, Miles EA, Calder PC. Anti-inflammatory effects of oleic acid and the anthocyanin keracyanin alone and in combination: effects on monocyte and macrophage responses and the NF-\u0026kappa;B pathway. Food Funct. 2021 Sep 7;12(17):7909-7922. doi: 10.1039/d1fo01304a. Epub 2021 Jul 12. PMID: 34250536.\u003c/li\u003e\n\u003cli\u003eConsuelo Santa-Mar\u0026iacute;a,Soledad L\u0026oacute;pez-Enr\u0026iacute;quez, Sergio Montserrat-de la Paz, Isabel Geniz 3, Mar\u0026iacute;a Edith Reyes-Quiroz, Manuela Moreno, Francisca Palomares, Francisco Sobrino and Gonzalo Alba. Update on Anti-Inflammatory Molecular Mechanisms Induced by Oleic Acid. Nutrients 2023, 15(1), 224. \u003c/li\u003e\n\u003cli\u003eMaria Chiara Bruno, Agnese Gagliardi, Antonia Mancuso, Antonella Barone, Martine Tarsitano, Donato Cosco, Maria Chiara Cristiano, Massimo Fresta, Donatella Paolino. Oleic acid-based vesicular nanocarriers for topical delivery of the natural drug thymoquinone: Improvement of anti-inflammatory activity. J Control Release. 2022 Dec; 352:74-86.DOI: 10.3390/nu15010224\u003c/li\u003e\n\u003cli\u003eChen CJ, Kumar KJ, Chen YT, Tsao NW, Chien SC, Chang ST, Chu FH, Wang SY. Effect of Hinoki and Meniki Essential Oils on Human Autonomic Nervous System Activity and Mood States. Nat Prod Commun. 2015 Jul;10(7):1305-8. PMID: 26411036.\u003c/li\u003e\n\u003cli\u003eSattayakhom A, Wichit S, Koomhin P. The Effects of Essential Oils on the Nervous System: A Scoping Review. Molecules. 2023 Apr 27;28(9):3771. doi: 10.3390/molecules28093771. PMID: 37175176; PMCID: PMC10180368.DOI: 10.3390/molecules28093771\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Mahabala Tailam, Vatavyadhi, GC–MS (Gas Chromatography–Mass Spectrometry), α-Cadinol, δ-Cadinene, Oligospermia","lastPublishedDoi":"10.21203/rs.3.rs-8684241/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8684241/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eMahabala Tailam is a classical Ayurvedic medicated oil described in the \u003cem\u003eBhaishajya Ratnavali\u003c/em\u003e 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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eAim\u003c/b\u003e\u003c/p\u003e \u003cp\u003eTo 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\u0026ndash;MS analysis.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMaterials and Methods\u003c/b\u003e\u003c/p\u003e \u003cp\u003eA 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\u0026rsquo;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\u0026ndash;mass spectrometry (GC\u0026ndash;MS) with compound identification based on retention indices and the NIST library.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe 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\u0026ndash;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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusion\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis 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.\u003c/p\u003e","manuscriptTitle":"Real-World Multicentre Observational Study and Phytochemical Profiling of Mahabala Tailam: Physician- Reported Usage Patterns and Clinical Perceptions from India","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-23 08:49:21","doi":"10.21203/rs.3.rs-8684241/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"9dedd90e-a3f9-4065-a0cd-8c82a3483471","owner":[],"postedDate":"February 23rd, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-04-28T01:09:40+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-23 08:49:21","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8684241","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8684241","identity":"rs-8684241","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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