Thymoquinone and therapeutic potentials: Updated evidences from clinical trials

Abstract

Thymoquinone (TQ), the primary active componentof the Nigella sativa(Black seed) oil, has demonstrated a broad spectrum of pharmacological effects in preclinicalin vitro and in animal models. However, clinical research evaluating its safety and efficacy in humans remains limited, partly due to biopharmaceutical limitations. This reviewaims to summarize and critically assess the current clinical evidence for TQ.A systematic search was conducted using PubMed, Web of Science, Scopusdatabases and ClinicalTrials.gov, with the keywords"thymoquinone" and "clinical trial". of the search identified ten completed clinical studies exploring the clinical utility of TQ in various human conditions,including type 2 diabetes, cancer, COVID-19, epilepsy and chronic periodontitis. Moreover, sevenclinical studiesare ongoing. Overall, published trials suggest that TQ is generally well-tolerated and may provide therapeutic benefits in select conditions. Nonetheless, the small number of trials, limited sample sizes, and variability in dosing and formulations present challenges in drawing definitive conclusions. Further well-designed, large-scale clinical studies are warranted to establish the efficacy, optimal dosing strategies, and long-term safety of TQ in human populations.