Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery

Not Applicable

Completed

• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Interventions: Other: application of different topical nasal solutions

• Registration Number: NCT06437717
• Lead Sponsor: Mansoura University

Brief 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 surgery) combined with different types of nasal irrigation which may affect formulation efficacy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-25
• Study First Submitted QC: 2024-05-25
• Last Update Submitted: 2024-05-25
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patient age between 18 and 60 years old.
2. chronic rhinosinusitis patients who have undergone endoscopic sinus surgery.

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Exclusion Criteria

1. Patients with history of allergy for sesame seed derivatives.
2. Patients with chronic diseases which affecting the process of healing (uncontrolled DM, renal failure and hepatic failure).
3. Patients with nasal granulomas.
4. Patients with invasive fungal rhinosinusitis.
5. Smokers.
6. Patients with history of radio and/or chemotherapy exposure.
7. Patients with systemic diseases affecting integrity of nasal mucosa (e.g. CF, scleroderma, Sjogren syndrome ...).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
only normal saline as nasal irrigation	application of different topical nasal solutions	-
normal saline as nasal irrigation followed by sesame oil nasal drops	application of different topical nasal solutions	-
Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops	application of different topical nasal solutions	-
only Ringer's lactate solution as nasal irrigation	application of different topical nasal solutions	-

Primary Outcome Measures

Name	Time	Method
Sinonasal Outcome Test 22 (SNOT-22)	weekly for three months
Lund-Kennedy endoscopic grading system	once monthly for three months

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Dakahliya, Egypt