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

NCT03208790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-04-20

No results posted yet for this study

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)

Conditions

  • Premalignant Lesion

Interventions

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Fatheya Zahran · Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

  • Basma Abdelalim · Lecturer of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2020-03-12
Completion
2020-03-12

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03208790 on ClinicalTrials.gov