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

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)

Study Overview

• Status: Completed
• Conditions: Premalignant Lesion
• Intervention / Treatment: Drug: Nigella sativa buccal tablets 10mg; Drug: Nigella sativa buccal tablets 5mg; Drug: Placebo buccal tablets

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical response	dimension of the lesion	baseline
clinical response	dimension of the lesion	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular evidence of malignant transformation	Immunohistochemical analysis using specific markers for cell proliferation(ki67)	baseline
Molecular evidence of malignant transformation	Immunohistochemical analysis using specific markers for cell proliferation(ki67)	3 months
Molecular evidence of malignant transformation	Immunohistochemical analysis using specific markers for apoptosis(caspase3)	baseline
Molecular evidence of malignant transformation	Immunohistochemical analysis using specific markers for apoptosis(caspase3)	3 months

Collaborators and Investigators

• Sponsor: 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.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2017
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 17, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: TQ-OPML

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No