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

September 7, 2025 updated by: Noha A.Elkholy, Mansoura University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahliya
      • Al Mansurah, Dakahliya, Egypt, 35511
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 …).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: only normal saline as nasal irrigation
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
Active Comparator: normal saline as nasal irrigation followed by sesame oil nasal drops
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
Active Comparator: only Ringer's lactate solution as nasal irrigation
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
Active Comparator: Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

May 25, 2024

First Submitted That Met QC Criteria

May 25, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 7, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.20.5.1134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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