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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03208790

Enrollment

Registered

2017-07-06

Start date

2017-09-30

Completion date

2020-03-12

Last updated

2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premalignant Lesion

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)

Interventions

DRUGNigella sativa buccal tablets 10mg

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

DRUGNigella sativa buccal tablets 5mg

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

DRUGPlacebo buccal tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
clinical response	baseline	dimension of the lesion

Secondary

Measure	Time frame	Description
Molecular evidence of malignant transformation	baseline	Immunohistochemical analysis using specific markers for cell proliferation(ki67)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026