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

NCT03208790 | Completed Phase 2

• 1 other identifier: TQ-OPML
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• clinical response

  dimension of the lesion

  baseline

• clinical response

  dimension of the lesion

  3 months

Secondary Outcomes (4)

• Molecular evidence of malignant transformation

  baseline

• Molecular evidence of malignant transformation

  3 months

• Molecular evidence of malignant transformation

  baseline

• Molecular evidence of malignant transformation

  3 months

Study Arms (3)

Group A

EXPERIMENTAL

patients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months.

Drug: Nigella sativa buccal tablets 10mg

Group B

EXPERIMENTAL

patients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months.

Drug: Nigella sativa buccal tablets 5mg

Group 3

PLACEBO COMPARATOR

patients with oral premalignant lesions will receive placebo buccal tablets for 3 months.

Drug: Placebo buccal tablets

Interventions

Nigella sativa buccal tablets 10mg DRUG

thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg

Also known as: Nigella Sativa, thymoquinone

Group A

Nigella sativa buccal tablets 5mg DRUG

thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg

Also known as: Nigella Sativa, thymoquinone

Group B

Placebo buccal tablets DRUG

capsules with the same color and form as the active ones but without active ingredient will be given to the patients

Group 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with age range 18-75 years.
• Patients with any known potentially malignant lesion confirmed histologically and clinically.

You may not qualify if:

• Patients with systemic illness.
• Patients received previous treatment for the condition.
• Current malignancy.
• Pregnant or lactating women.
• Hypersensitivity to the intervention.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 11553, Egypt

Location

Related 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. doi: 10.1016/j.oraloncology.2003.12.011.

  PMID: 15063387 BACKGROUND

MeSH Terms

Interventions

Nigella sativa oil; thymoquinone

Study Officials

• Fatheya Zahran

  Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

  STUDY CHAIR

• Basma Abdelalim

  Lecturer of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 6, 2017
• Study Start: September 30, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: April 20, 2021

Record last verified: 2020-09

Locations

EG (1)