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

Primary Purpose

Premalignant Lesion

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Nigella sativa buccal tablets 10mg

Nigella sativa buccal tablets 5mg

Placebo buccal tablets

About this trial

This is an interventional treatment trial for Premalignant Lesion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

clinical response

dimension of the lesion

clinical response

dimension of the lesion

Secondary Outcome Measures

Molecular evidence of malignant transformation

Immunohistochemical analysis using specific markers for cell proliferation(ki67)

Molecular evidence of malignant transformation

Immunohistochemical analysis using specific markers for cell proliferation(ki67)

Molecular evidence of malignant transformation

Immunohistochemical analysis using specific markers for apoptosis(caspase3)

Molecular evidence of malignant transformation

Immunohistochemical analysis using specific markers for apoptosis(caspase3)

Full Information

NCT ID

NCT03208790

First Posted

July 3, 2017

Last Updated

April 17, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03208790

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

September 30, 2017 (Actual)

Primary Completion Date

March 12, 2020 (Actual)

Study Completion Date

March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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)

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premalignant Lesion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Arm Title

Group 3

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nigella sativa buccal tablets 10mg

Other Intervention Name(s)

Nigella Sativa, thymoquinone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nigella sativa buccal tablets 5mg

Other Intervention Name(s)

Nigella Sativa, thymoquinone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo buccal tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

clinical response

Description

dimension of the lesion

Time Frame

baseline

Title

clinical response

Description

dimension of the lesion

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Molecular evidence of malignant transformation

Description

Immunohistochemical analysis using specific markers for cell proliferation(ki67)

Time Frame

baseline

Title

Molecular evidence of malignant transformation

Description

Immunohistochemical analysis using specific markers for cell proliferation(ki67)

Time Frame

3 months

Title

Molecular evidence of malignant transformation

Description

Immunohistochemical analysis using specific markers for apoptosis(caspase3)

Time Frame

baseline

Title

Molecular evidence of malignant transformation

Description

Immunohistochemical analysis using specific markers for apoptosis(caspase3)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fatheya Zahran

Organizational Affiliation

Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Basma Abdelalim

Organizational Affiliation

Lecturer of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry

City

Cairo

ZIP/Postal Code

11553

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

15063387

Citation

Singh M, Krishanappa R, Bagewadi A, Keluskar V. Efficacy of oral lycopene in the treatment of oral leukoplakia. Oral Oncol. 2004 Jul;40(6):591-6. doi: 10.1016/j.oraloncology.2003.12.011.

Results Reference

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

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