Chronic Rhinosinusitis (Diagnosis)NCT06437717
Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery
A study testing application of different topical nasal solutions in people with Chronic Rhinosinusitis (Diagnosis), run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of our thesis is to design, develop and characterize a novel thermodynamically stable NE by spontaneous method intended for topical use. Subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in CRS patients who have undergone ESS (endoscopic sinus… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- application of different topical nasal solutions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Mar 2024
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient age between 18 and 60 years old.
- chronic rhinosinusitis patients who have undergone endoscopic sinus surgery.
Who cannot join
- Patients with history of allergy for sesame seed derivatives.
- Patients with chronic diseases which affecting the process of healing (uncontrolled DM, renal failure and hepatic failure).
- Patients with nasal granulomas.
- Patients with invasive fungal rhinosinusitis.
- Smokers.
- Patients with history of radio and/or chemotherapy exposure.
- Patients with systemic diseases affecting integrity of nasal mucosa (e.g. CF, scleroderma, Sjogren syndrome …).
Trial locations and contacts
1 site in 1 country.
About this study
The goal of our thesis is to design, develop and characterize a novel thermodynamically stable NE by spontaneous method intended for topical use. Subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in CRS patients who have undergone ESS (endoscopic sinus surgery) combined with different types of nasal irrigation which may affect formulation efficacy.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- application of different topical nasal solutions
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of different topical nasal solutionsOther
each group receives a type of nasal solution to detect if there is a difference in the outcomes in chronic rhinosinusitis patients
| Study group | Role | What they receive |
|---|---|---|
| only normal saline as nasal irrigation | Active comparator | Not described Receives: Other: application of different topical nasal solutions |
| normal saline as nasal irrigation followed by sesame oil nasal drops | Active comparator | Not described Receives: Other: application of different topical nasal solutions |
| only Ringer's lactate solution as nasal irrigation | Active comparator | Not described Receives: Other: application of different topical nasal solutions |
| Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops | Active comparator | Not described Receives: Other: application of different topical nasal solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinonasal Outcome Test 22 (SNOT-22)
Measured: weekly for three months
Lund-Kennedy endoscopic grading system
Measured: once monthly for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha A.Elkholy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437717
- Sponsor's protocol ID
- MS.20.5.1134
- Status last verified
- May 2024
- First submitted
- 25 May 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT06437717
- Acronym / sponsor ID
- MS.20.5.1134
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 31 May 2024 (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 goal of our thesis is to design, develop and characterize a novel thermodynamically stable NE by spontaneous method intended for topical use. Subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in CRS patients who have undergone ESS (endoscopic sinus surgery) combined with different types of nasal irrigation which may affect formulation efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| only normal saline as nasal irrigation | Active comparator | Other: application of different topical nasal solutions |
| normal saline as nasal irrigation followed by sesame oil nasal drops | Active comparator | Other: application of different topical nasal solutions |
| only Ringer's lactate solution as nasal irrigation | Active comparator | Other: application of different topical nasal solutions |
| Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops | Active comparator | Other: application of different topical nasal solutions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient age between 18 and 60 years old.
- chronic rhinosinusitis patients who have undergone endoscopic sinus surgery.
Key exclusion criteria (7 listed)
- Patients with history of allergy for sesame seed derivatives.
- Patients with chronic diseases which affecting the process of healing (uncontrolled DM, renal failure and hepatic failure).
- Patients with nasal granulomas.
- Patients with invasive fungal rhinosinusitis.
- Smokers.
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 |
|---|---|---|
| application of different topical nasal solutionseach group receives a type of nasal solution to detect if there is a difference in the outcomes in chronic rhinosinusitis patients | Other | Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops, normal saline as nasal irrigation followed by sesame oil nasal drops, only Ringer's lactate solution as nasal irrigation, only normal saline as nasal irrigation |
Primary outcome
Sinonasal Outcome Test 22 (SNOT-22)
Time frame: weekly for three months
Lund-Kennedy endoscopic grading system
Time frame: once monthly for three 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 12 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of different topical nasal solutions in people with Chronic Rhinosinusitis (Diagnosis), run by Mansoura 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 7 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 12 Sep 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Sinonasal Outcome Test 22 (SNOT-22) (time frame: weekly for three months). 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?
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 12 Sep 2025.