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

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06437717
• Other study ID #: MS.20.5.1134
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patient age between 18 and 60 years old.

2. chronic rhinosinusitis patients who have undergone endoscopic sinus surgery.

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 …).

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Rhinosinusitis

Intervention

Other:
• application of different topical nasal solutions
each group receives a type of nasal solution to detect if there is a difference in the outcomes in chronic rhinosinusitis patients

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahliya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinonasal Outcome Test 22 (SNOT-22)		weekly for three months
Primary	Lund-Kennedy endoscopic grading system		once monthly for three months