TY  - JOUR
TI  - Evaluation of thymoquinone cancer chemo-preventive effect on oral leukoplakia: a randomized clinical trial
AU  - Nabil, Ghada
AU  - Zahran, Fat’heya M.
AU  - ElMeshad, Aliaa
AU  - Fawzy, Ahmed
AU  - Ghalwash, Dalia
AU  - Elsaadany, Basma
PY  - 2025
JO  - Exploration of Medicine
VL  - 6
SP  - 1001290
DO  - 10.37349/emed.2025.1001290
UR  - https://www.explorationpub.com/Journals/em/Article/1001290
AB  - Aim: This randomized clinical trial aimed to investigate the chemo-preventive role of thymoquinone in Nigella sativa extract in managing oral leukoplakia clinically, histologically, and at the molecular level. Methods: A total of 48 patients with oral leukoplakia were randomly allocated to three groups; Group A received local muco-adhesive tablets with Nigella sativa extract in 10 mg/kg dose, for three months, Group B same intervention but with Nigella sativa extract in 5 mg/kg dose, and lastly Group C was the placebo group. The outcomes assessed were clinical improvement, histologic improvement (degree of dysplasia), and molecular biomarkers Ki-67 and caspase-3 by immunohistochemistry. Results: There was a statistically significant decrease in lesion size in Groups A and B compared to the placebo group. At the molecular level, there was a statistically significant decrease in the expression of Ki-67 in both the Nigella sativa groups compared to the placebo group. While there was a statistically significant increase in caspase-3 in Group A only compared to the other groups. Conclusions: Thymoquinone in Nigella sativa extract is a promising chemo-preventive agent that can be used in the management of oral leukoplakia (the trial is registered on clinicaltrials.gov identifier: NCT03208790).
ER  -