NCT03208790

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Premalignant Lesion

Interventions

Type	Name	Description
DRUG	Nigella sativa buccal tablets 10mg	thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg
DRUG	Nigella sativa buccal tablets 5mg	thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg
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

Timeline

• Start date: 2017-09-30
• Primary completion: 2020-03-12
• Completion: 2020-03-12
• First posted: 2017-07-06
• Last updated: 2021-04-20

Locations

1 site across 1 country: Egypt