Clinical and Immunohisochemical Evaluation of Chemopreventive Effect of Thymoquinone on Oral Potentially Malignant Lesions.
NCT ID: NCT03208790
Last Updated: 2021-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2017-09-30
2020-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
patients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months.
Nigella sativa buccal tablets 10mg
thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg
Group B
patients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months.
Nigella sativa buccal tablets 5mg
thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg
Group 3
patients with oral premalignant lesions will receive placebo buccal tablets for 3 months.
Placebo buccal tablets
capsules with the same color and form as the active ones but without active ingredient will be given to the patients
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with any known potentially malignant lesion confirmed histologically and clinically.
Exclusion Criteria
* Patients received previous treatment for the condition.
* Current malignancy.
* Pregnant or lactating women.
* Hypersensitivity to the intervention.
18 Years
75 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ghada Nabil
Assistant lecturer
Principal Investigators
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Fatheya Zahran
Role: STUDY_CHAIR
Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
Basma Abdelalim
Role: STUDY_DIRECTOR
Lecturer of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
Locations
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Faculty of Dentistry
Cairo, , Egypt
Countries
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References
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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.
Other Identifiers
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TQ-OPML
Identifier Type: -
Identifier Source: org_study_id
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