Clinical trial · Interventional
Clinical and Immunohisochemical Evaluation of Chemopreventive Effect of Thymoquinone on Oral Potentially Malignant Lesions.
Clinical And Immunohistochemical Evaluation Of The Cancer Chemopreventive Effect Of Thymoquinone Compared To A Placebo On Oral Potentially Malignant Lesions Among An Egyptian Population : A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present randomized, controlled, parallel-grouped trial includes 48 patients (aged 18 to 75 years) suffering from oral potential premalignant lesions. Patients will be randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Premalignant Lesion | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nigella sativa buccal tablets 10mg | Drug | — | UNRESOLVED |
| Nigella sativa buccal tablets 5mg | Drug | — | UNRESOLVED |
| Placebo buccal tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group A
- description
- patients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months.
- interventionNames
- Drug: Nigella sativa buccal tablets 10mg
- type
- EXPERIMENTAL
- label
- Group B
- description
- patients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months.
- interventionNames
- Drug: Nigella sativa buccal tablets 5mg
- type
- PLACEBO_COMPARATOR
- label
- Group 3
- description
- patients with oral premalignant lesions will receive placebo buccal tablets for 3 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion Criteria: * Patients with age range 18-75 years. * Patients with any known potentially malignant lesion confirmed histologically and clinically. Exclusion Criteria: * Patients with systemic illness. * Patients received previous treatment for the condition. * Current malignancy. * Pregnant or lactating women. * Hypersensitivity to the intervention.
References
Publications (1)
- BACKGROUNDSingh M, Krishanappa R, Bagewadi A, Keluskar V. Efficacy of oral lycopene in the treatment of oral leukoplakia. Oral Oncol. 2004 Jul;40(6):591-6. doi: 10.1016/j.oraloncology.2003.12.011. PMID 15063387