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

Phase 2CompletedNCT03208790

Cairo University48 enrolled

Overview

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)

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Premalignant Lesion

Interventions

Nigella sativa buccal tablets 10mgDRUG

thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg

Nigella sativa buccal tablets 5mgDRUG

thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg

Placebo buccal tabletsDRUG

capsules with the same color and form as the active ones but without active ingredient will be given to the patients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry

Cairo, Egypt

Outcomes

Primary Outcomes

clinical response

dimension of the lesion

Time frame: baseline

clinical response

dimension of the lesion

Time frame: 3 months

Secondary Outcomes

Molecular evidence of malignant transformation

Immunohistochemical analysis using specific markers for cell proliferation(ki67)

Time frame: baseline

Molecular evidence of malignant transformation

Immunohistochemical analysis using specific markers for cell proliferation(ki67)

Time frame: 3 months

Molecular evidence of malignant transformation

Immunohistochemical analysis using specific markers for apoptosis(caspase3)

Time frame: baseline

Molecular evidence of malignant transformation

Immunohistochemical analysis using specific markers for apoptosis(caspase3)

Time frame: 3 months

Data from ClinicalTrials.gov

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