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

M

Mansoura University

Status

Completed

Conditions

Chronic Rhinosinusitis (Diagnosis)

Treatments

Other: application of different topical nasal solutions

Study type

Interventional

Funder types

Other

Identifiers

NCT06437717
MS.20.5.1134

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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 ...).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 4 patient groups

only normal saline as nasal irrigation
Active Comparator group
Treatment:
Other: application of different topical nasal solutions
normal saline as nasal irrigation followed by sesame oil nasal drops
Active Comparator group
Treatment:
Other: application of different topical nasal solutions
only Ringer's lactate solution as nasal irrigation
Active Comparator group
Treatment:
Other: application of different topical nasal solutions
Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops
Active Comparator group
Treatment:
Other: application of different topical nasal solutions

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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