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

Premalignant Lesion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208790
• Other study ID #: TQ-OPML
• Status: Completed
• Phase: Phase 2
• Start date: September 30, 2017
• Est. completion date: March 12, 2020

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Precancerous Conditions
• Premalignant Lesion

Intervention

Drug:
• Nigella sativa buccal tablets 10mg
thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg
• Nigella sativa buccal tablets 5mg
thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg
• Placebo buccal tablets
capsules with the same color and form as the active ones but without active ingredient will be given to the patients

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response	dimension of the lesion	baseline
Primary	clinical response	dimension of the lesion	3 months
Secondary	Molecular evidence of malignant transformation	Immunohistochemical analysis using specific markers for cell proliferation(ki67)	baseline
Secondary	Molecular evidence of malignant transformation	Immunohistochemical analysis using specific markers for cell proliferation(ki67)	3 months
Secondary	Molecular evidence of malignant transformation	Immunohistochemical analysis using specific markers for apoptosis(caspase3)	baseline
Secondary	Molecular evidence of malignant transformation	Immunohistochemical analysis using specific markers for apoptosis(caspase3)	3 months