## Protocol Section
### Identification Module
**NCT ID:** NCT06437717

**Brief Title:** Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery

**Official Title:** Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery

#### Organization Study ID Info
**ID:** MS.20.5.1134
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2024-03-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mansoura University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Chronic Rhinosinusitis (Diagnosis)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: application of different topical nasal solutions

**Label:** only normal saline as nasal irrigation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Other: application of different topical nasal solutions

**Label:** normal saline as nasal irrigation followed by sesame oil nasal drops

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Other: application of different topical nasal solutions

**Label:** only Ringer's lactate solution as nasal irrigation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

**Intervention Names:**

- Other: application of different topical nasal solutions

**Label:** Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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

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

**Name:** application of different topical nasal solutions

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Sinonasal Outcome Test 22 (SNOT-22)

**Time Frame:** weekly for three months

**Measure:** Lund-Kennedy endoscopic grading system

**Time Frame:** once monthly for three months

### Eligibility Module

**Eligibility Criteria:** 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 ...).

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mansoura

**Country:** Egypt

**Facility:** Mansoura University

**State:** Dakahliya

**Zip:** 35511

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012220

- Term: Rhinitis

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000012852

- Term: Sinusitis

- ID: D000010254

- Term: Paranasal Sinus Diseases

- ID: D000009668

- Term: Nose Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3269

- Name: Rhinosinusitis

- Relevance: HIGH

- As Found: Rhinosinusitis

- ID: M15049

- Name: Rhinitis

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15657

- Name: Sinusitis

- Relevance: LOW

- As Found: Unknown

- ID: M13167

- Name: Paranasal Sinus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12604

- Name: Nose Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T5183

- Name: SeSAME Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000096825

- Term: Rhinosinusitis

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
