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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03208790
Collaborator
(none)
48
Enrollment
1
Location
3
Arms
29.4
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Nigella sativa buccal tablets 10mg
  • Drug: Nigella sativa buccal tablets 5mg
  • Drug: Placebo buccal tablets
 Phase 2

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Sep 30, 2017
Actual Primary Completion Date :
Mar 12, 2020
Actual Study Completion Date :
Mar 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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

Drug: Nigella sativa buccal tablets 10mg
thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg
Other Names:
  • Nigella Sativa
  • thymoquinone

    		•
    Experimental: Group B

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

    Drug: Nigella sativa buccal tablets 5mg
    thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg
    Other Names:
  • Nigella Sativa
  • thymoquinone

    		•
    Placebo Comparator: Group 3

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

    Drug: Placebo buccal tablets
    capsules with the same color and form as the active ones but without active ingredient will be given to the patients

    Outcome Measures

    Primary Outcome Measures

    1. clinical response [baseline]

      dimension of the lesion

    2. clinical response [3 months]

      dimension of the lesion

    Secondary Outcome Measures

    1. Molecular evidence of malignant transformation [baseline]

      Immunohistochemical analysis using specific markers for cell proliferation(ki67)

    2. Molecular evidence of malignant transformation [3 months]

      Immunohistochemical analysis using specific markers for cell proliferation(ki67)

    3. Molecular evidence of malignant transformation [baseline]

      Immunohistochemical analysis using specific markers for apoptosis(caspase3)

    4. Molecular evidence of malignant transformation [3 months]

      Immunohistochemical analysis using specific markers for apoptosis(caspase3)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry Cairo Egypt 11553

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Chair: Fatheya Zahran, Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
    • Study Director: Basma Abdelalim, Lecturer of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ghada Nabil, Assistant lecturer, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03208790
    Other Study ID Numbers:
    • TQ-OPML
    First Posted:
    Jul 6, 2017
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Precancerous Conditions

    Study Results

    No Results Posted as of Apr 20, 2021