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

Cairo University (CU)

Status and phase: Completed; Phase 2

Conditions: Premalignant Lesion

Treatments: Drug: Nigella sativa buccal tablets 10mg; Drug: Placebo buccal tablets; Drug: Nigella sativa buccal tablets 5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03208790

TQ-OPML

Details and patient eligibility

About

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)

Full 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)

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 3 patient groups, including a placebo group

Group A

Experimental group

Description:

patients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months.

Treatment:

Drug: Nigella sativa buccal tablets 10mg

Group B

Experimental group

Description:

patients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months.

Treatment:

Drug: Nigella sativa buccal tablets 5mg

Group 3

Placebo Comparator group

Description:

patients with oral premalignant lesions will receive placebo buccal tablets for 3 months.

Treatment:

Drug: Placebo buccal tablets