Clinical and Immunohisochemical Evaluation of Chemopreventive Effect of Thymoquinone on Oral Potentially Malignant Lesions.

Study Overview
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Brief Summary
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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)

Detailed Description
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The present randomized, controlled, parallel-grouped trial included 48 patients (aged 18 to 75 years) suffering from oral potentially premalignant lesions. Patients were 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)

Official Title
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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

Conditions
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Premalignant Lesion

Intervention / Treatment
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* Drug: Nigella sativa buccal tablets 10mg
* Drug: Nigella sativa buccal tablets 5mg
* Drug: Placebo buccal tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>patients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months. | Drug: Nigella sativa buccal tablets 10mg<br>* thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg<br>* Other names: thymoquinone;|
| Experimental: Group B<br>patients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months. | Drug: Nigella sativa buccal tablets 5mg<br>* thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg<br>* Other names: thymoquinone;|
| Placebo Comparator: Group 3<br>patients with oral premalignant lesions will receive placebo buccal tablets for 3 months. | Drug: Placebo buccal tablets<br>* capsules with the same color and form as the active ones but without active ingredient will be given to the patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response | dimension of the lesion | baseline | 
| clinical response | dimension of the lesion | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular evidence of malignant transformation | Immunohistochemical analysis using specific markers for cell proliferation(ki67) | baseline | 
| Molecular evidence of malignant transformation | Immunohistochemical analysis using specific markers for cell proliferation(ki67) | 3 months | 
| Molecular evidence of malignant transformation | Immunohistochemical analysis using specific markers for apoptosis(caspase3) | baseline | 
| Molecular evidence of malignant transformation | Immunohistochemical analysis using specific markers for apoptosis(caspase3) | 3 months |