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

Phase 2

Completed

• Conditions: Premalignant Lesion
• Interventions: Drug: Nigella sativa buccal tablets 10mg; Drug: Placebo buccal tablets; Drug: Nigella sativa buccal tablets 5mg

• Registration Number: NCT03208790
• Lead Sponsor: Cairo University

Brief Summary

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

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Study Start: 2017-09-30
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Status Verified: 2020-09
• Last Update Submitted: 2021-04-17
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Inclusion Criteria:

• Patients with age range 18-75 years.
• Patients with any known potentially malignant lesion confirmed histologically and clinically.

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Exclusion Criteria

• Patients with systemic illness.
• Patients received previous treatment for the condition.
• Current malignancy.
• Pregnant or lactating women.
• Hypersensitivity to the intervention.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Nigella sativa buccal tablets 10mg	patients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months.
Group 3	Placebo buccal tablets	patients with oral premalignant lesions will receive placebo buccal tablets for 3 months.
Group B	Nigella sativa buccal tablets 5mg	patients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months.

Primary Outcome Measures

Name	Time	Method
clinical response	3 months	dimension of the lesion

Secondary Outcome Measures

Name	Time	Method
Molecular evidence of malignant transformation	3 months	Immunohistochemical analysis using specific markers for apoptosis(caspase3)

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt