Premalignant LesionPhase 2NCT03208790
Clinical and Immunohisochemical Evaluation of Chemopreventive Effect of Thymoquinone on Oral Potentially Malignant Lesions.
A Phase 2 study testing Nigella sativa buccal tablets 10mg and Nigella sativa buccal tablets 5mg in people with Premalignant Lesion, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Premalignant Lesion
- What is being tested?
- Nigella sativa buccal tablets 10mg and Nigella sativa buccal tablets 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2017to 12 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age range 18-75 years.
- Patients with any known potentially malignant lesion confirmed histologically and clinically.
Who cannot join
- Patients with systemic illness.
- Patients received previous treatment for the condition.
- Current malignancy.
- Pregnant or lactating women.
- Hypersensitivity to the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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
- Being tested
- Nigella sativa buccal tablets 10mg, Nigella sativa buccal tablets 5mg, Placebo buccal tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella sativa buccal tablets 10mgDrug
Also called Nigella Sativa, thymoquinone
thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg
Nigella sativa buccal tablets 5mgDrug
Also called Nigella Sativa, thymoquinone
thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg
Placebo buccal tabletsDrug
capsules with the same color and form as the active ones but without active ingredient will be given to the patients
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | patients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months. Receives: Drug: Nigella sativa buccal tablets 10mg |
| Group B | Experimental | patients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months. Receives: Drug: Nigella sativa buccal tablets 5mg |
| Group 3 | Placebo comparator | patients with oral premalignant lesions will receive placebo buccal tablets for 3 months. Receives: Drug: Placebo buccal tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response
dimension of the lesion
Measured: baseline
clinical response
dimension of the lesion
Measured: 3 months
Secondary outcomes (4)
Molecular evidence of malignant transformation
Immunohistochemical analysis using specific markers for cell proliferation(ki67)
Measured: baseline
Molecular evidence of malignant transformation
Immunohistochemical analysis using specific markers for cell proliferation(ki67)
Measured: 3 months
Molecular evidence of malignant transformation
Immunohistochemical analysis using specific markers for apoptosis(caspase3)
Measured: baseline
Molecular evidence of malignant transformation
Immunohistochemical analysis using specific markers for apoptosis(caspase3)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start30 Sep 2017
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premalignant LesionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Nabil, Cairo University
- Investigators
- Fatheya Zahran, Study chair, Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.Basma Abdelalim, Study director, Lecturer of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208790
- Sponsor's protocol ID
- TQ-OPML
- Status last verified
- Sep 2020
- First submitted
- 3 Jul 2017
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15063387
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03208790
- Acronym / sponsor ID
- TQ-OPML
- Conditions
- Premalignant Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Nigella sativa buccal tablets 10mgpatients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months. |
| Group B | Experimental | Drug: Nigella sativa buccal tablets 5mgpatients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months. |
| Group 3 | Placebo comparator | Drug: Placebo buccal tabletspatients with oral premalignant lesions will receive placebo buccal tablets for 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with age range 18-75 years.
- Patients with any known potentially malignant lesion confirmed histologically and clinically.
Key exclusion criteria (5 listed)
- Patients with systemic illness.
- Patients received previous treatment for the condition.
- Current malignancy.
- Pregnant or lactating women.
- Hypersensitivity to the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nigella sativa buccal tablets 10mgAlso: Nigella Sativa, thymoquinonethymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg | Drug | Group A |
| Nigella sativa buccal tablets 5mgAlso: Nigella Sativa, thymoquinonethymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg | Drug | Group B |
| Placebo buccal tabletscapsules with the same color and form as the active ones but without active ingredient will be given to the patients | Drug | Group 3 |
Primary outcome
clinical response
Time frame: baseline
dimension of the lesion
clinical response
Time frame: 3 months
dimension of the lesion
4 secondary outcomes
Molecular evidence of malignant transformation
Time frame: baseline
Molecular evidence of malignant transformation
Time frame: 3 months
Molecular evidence of malignant transformation
Time frame: baseline
Molecular evidence of malignant transformation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Background: PubMed 15063387Singh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatheya Zahran study chair
Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
Basma Abdelalim study director
Lecturer of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nigella sativa buccal tablets 10mg and Nigella sativa buccal tablets 5mg in people with Premalignant Lesion, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical response (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03208790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.