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

NCT06437717 | Completed

• 1 other identifier: MS.20.5.1134
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (2)

• Sinonasal Outcome Test 22 (SNOT-22)

  weekly for three months

• Lund-Kennedy endoscopic grading system

  once monthly for three months

Study Arms (4)

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

Interventions

application of different topical nasal solutions OTHER

each group receives a type of nasal solution to detect if there is a difference in the outcomes in chronic rhinosinusitis patients

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 …).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahliya, 35511, Egypt

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: May 31, 2024
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 12, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)