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OpenTrials
Completed

NCT Number: NCT03208790

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

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)

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Key information

Conditions

Premalignant Lesion

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry

Cairo, 11553, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nigella sativa buccal tablets 10mg

Drug

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

Other names: Nigella Sativa, thymoquinone

Nigella sativa buccal tablets 5mg

Drug

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

Other names: Nigella Sativa, thymoquinone

Placebo buccal tablets

Drug

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

Primary outcomes

  1. clinical response

    Time frame: baseline

    dimension of the lesion

  2. clinical response

    Time frame: 3 months

    dimension of the lesion

Secondary outcomes

  1. Molecular evidence of malignant transformation

    Time frame: baseline

    Immunohistochemical analysis using specific markers for cell proliferation(ki67)

  2. Molecular evidence of malignant transformation

    Time frame: 3 months

    Immunohistochemical analysis using specific markers for cell proliferation(ki67)

  3. Molecular evidence of malignant transformation

    Time frame: baseline

    Immunohistochemical analysis using specific markers for apoptosis(caspase3)

  4. Molecular evidence of malignant transformation

    Time frame: 3 months

    Immunohistochemical analysis using specific markers for apoptosis(caspase3)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 6, 2017
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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