Shilajit Extract: Examining Biomedical Applications—A Systematic Review Protocol

Background: Shilajit, a natural mineral exudate utilized for centuries in traditional Ayurvedic and Eastern European medicine, is regarded as a traditional adaptogenic substance and rejuvenator. This systematic review synthesizes contemporary scientific evidence regarding the biomedical applications of Shilajit extract, critically evaluating its pharmacological properties and therapeutic potential. Methods: A systematic search was performed across PubMed, Scopus, Web of Science, and the Cochrane Library for peer-reviewed literature published between 1951 and 2026. Studies were screened against rigorous eligibility criteria, and methodological quality was appraised using the Cochrane Risk of Bias 2.0 and SYRCLE tools. Results: Studies were included in the final analysis. Characterized by high concentrations of fulvic acid and dibenzo-α-pyrones, Shilajit exhibits antioxidant activity, anti-inflammatory, neuroprotective, and adaptogenic activities. Preclinical data demonstrate dose-dependent cytotoxicity against multiple cancer cell lines via apoptosis induction. Furthermore, evidence suggests its efficacy in enhancing muscular strength, improving reproductive function, and mitigating protein aggregation in neurodegenerative contexts. Conclusions: Shilajit possesses significant biomedical potential that aligns with its traditional applications. However, clinical integration requires addressing standardization challenges, implementing stringent quality control to mitigate heavy metal risks, and conducting large-scale human trials to definitively establish safety and efficacy profiles.