Nasal PolypsNCT06070311
Wound Healing After Endoscopic Sinus Surgery
A study testing Thymoquinone (0.5%) and Olive oil ointment in people with Nasal Polyps and Chronic Sinusitis, run by Assiut University.
Trial summary
This study aims to determine the effect of Thymoquinone (0.5%) and olive oil ointment on Wound healing after Endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Polyps, Chronic Sinusitis
- What is being tested?
- Thymoquinone (0.5%) and Olive oil ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients who will be clinically diagnosed and radiologically confirmed cases with bilateral nasal polyposis indicated for Endoscopic sinus surgery.
Who cannot join
- Unfit patient for surgery
- Pregnant and lactating women.
- Patients unwilling to participate.
- Patients who have unilateral disease.
- Patients with a history of the following underlying medical conditions, which are associated with an increased rate of revision surgery, will be excluded from the study:
- Aspirin intolerance
Show all 11Show fewer
- Asthma
- Mucociliary disorder
- Immunocompromised status.
- Patients with known allergic reactions to Thymoquinone or olive oil.
- Injury of the orbit with any tear in the periorbital area.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Thymoquinone and Olive Oil on Wound Healing After Endoscopic Sinus Surgery in Patients With Nasal Polyposis
This study aims to determine the effect of Thymoquinone (0.5%) and olive oil ointment on Wound healing after Endoscopic sinus surgery.
Read the detailed description
Endoscopic sinus surgery (ESS) has become a widely accepted procedure for medically refractory chronic rhino sinusitis and nasal polyps. Over 250,000 endoscopic sinus surgeries are performed yearly in the United States alone, however, postoperative complications and disease recurrence requiring revision surgery are reported in 14% to 24% of patients in long-term follow-up.
There is an increasing interest in interventions and therapies targeted at optimizing outcomes and preventing revision surgery which often depends on good wound healing and less adhesion formation.
The choice of appropriate post-surgical topical treatments is important for healing time and for preventing mucosal complications such as adhesions, crusting formation, and atrophy with secondary bacterial and fungal infections in this light this study aims to determine the effect of thymoquinone and olive oil ointment on wound healing after ESS.
Thymoquinone (TQ) is the most abundant constituent of the volatile oil of Nigella sativa seeds and most properties of Nigella sativa are mainly attributed to TQ. Several pharmacological actions and therapeutic potentials of TQ have been investigated including being antioxidant, anti-inflammatory, antihistaminic, antimicrobial, anti-allergic, anti-fibrotic, and anti-cancer.
Olive oil plays an important role in wound healing process due to its content of phenolic compounds accelerating wound healing through their anti-inflammatory, antioxidant, and antimicrobial properties and their stimulation of angiogenic activities required for granulation tissue formation and wound re-epithelialization.
This Double Blinded Randomized Prospective Comparative study will follow patients with nasal polyposis who are indicated for endoscopic sinus surgery at the Department of Otorhinolaryngology in Assiut University Hospital during the period from the 1st of October 2023 to the 31st of September 2025.
At baseline (before surgery), a full medical history, an otorhinolaryngological examination, and pre-operative screening will be performed to ensure eligibility for the study. The patients will be informed about the surgical procedures, the potential risks of the surgery, and the aim and methodology of the study.
(A) Preoperative:
Full history taking:
- Personal History
- History of Sino-nasal symptoms e.g., nasal obstruction, nasal discharge, headache, hyposmia, facial congestion, etc.
- Other ENT symptoms
- General symptoms e.g., asthma, allergy, etc.
- Medical history e.g., steroids, antibiotics, anticholinergics, etc.
- History of nasal surgery
- SNOT 22 questionnaire: To assess preoperative severity of symptoms.
Full medical examination:
- General examination
- Full ENT examination
- Nasal Endoscopy:
- To evaluate polyp size, site, extent, and consistency.
Investigations:
- Routine preoperative investigations: CBC, prothrombin time and concentration
- Radiological investigations: Multi-slice CT scan of the nose and paranasal sinuses axial and coronal cuts without contrast and each patient will be scored according to Lund-Mackay CT scoring.
Preparation of the Thymoquinone and Olive oil ointment:
Thymoquinone Oleaginous base ointment containing olive oil will be prepared for intranasal administration. The ointment will be prepared using the fusion method as follows:
Anhydrous lanolin and white soft paraffin will be melted at 70°C and then olive oil will be added with continuous stirring, Thymoquinone will be added to the congealing mixture as it is being cooled and stirred finally, the congealing mixture is left to cool at room temperature tell solidification and sterilized using UV radiation. The final product will be characterized for spreadability, drug content, drug release and stability.
(B) Intraoperative: All cases will be performed under general anaesthesia and the ESS procedure performed by the senior author is that defined by Kennedy.
Immediately after performing the ESS, Thymoquinone and olive oil Ointment will be applied to fill the ethmoidal and different sinuses cavities of one randomly chosen side of the nose, the selected side will be chosen randomly using the following online randomizer tool:
Randomizer | Random Name/Number Picker - AnnaBet.com Then nasal packing with nasal sponge will be done for both sides.
(C) Postoperative: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery. At these visits, an endoscopic inspection will be performed, and the patients will undergo debridement of the ethmoid cavities when necessary. In addition, endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides regarding adhesions, crust formation, granulation, infection and score each item using the scoring mentioned below.
Crust formation:
0: No crust formation observed.
- Thin and easily removable crusts.
- Moderate crust formation, requiring gentle removal.
- Thick and adherent crusts, requiring careful and meticulous removal.
Adhesions:
0: No adhesions observed.
- Mild adhesions, limited to small areas.
- Moderate adhesions, affecting larger areas but without complete obstruction.
- Severe adhesions, causing significant obstruction and impaired sinus drainage. 3.Granulation:
0: No granulations observed.
- Mild granulation tissue, with minimal vascularity and minimal elevation.
- Moderate granulation tissue, with moderate vascularity and noticeable elevation.
- Severe granulation tissue, with marked vascularity and significant elevation. 4.Infection:
0: No signs or symptoms of infection observed.
- Mild infection, mucopurulent discharge limited to small area of the ethmoidal cavity.
- Moderate infection, mucopurulent discharge filling one sinus.
- Severe infection, mucopurulent discharge filling more than one sinus.
Participants will take the SNOT-22 questionnaire after the operation at the follow up visits to evaluate sino nasal symptoms.
- Conditions
- Nasal Polyps, Chronic Sinusitis
- Being tested
- Thymoquinone (0.5%) and Olive oil ointment
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymoquinone (0.5%) and Olive oil ointmentCombination product
Also called thymoquinone and olive oil ointment
Preparation of the Thymoquinone and Olive oil ointment:
Thymoquinone Oleaginous base ointment containing olive oil will be prepared for intranasal administration. The ointment will be prepared using the fusion method as follows:
Anhydrous lanolin and white soft paraffin will be melted at 70°C and then olive oil will be added with continuous stirring, Thymoquinone will be added to the congealing mixture as it is being cooled and stirred finally, the congealing mixture is left to cool at room temperature tell solidification and sterilized using UV radiation. The final product will be characterized for spreadability, drug content, drug release and stability.
| Study group | Role | What they receive |
|---|---|---|
| Thymoquinone (0.5%) and Olive oil ointment | Active comparator | thymoquinone (0.5%) and olive oil ointment will be applied to fill the ethmoidal and different sinuses cavities of one randomly chosen side of the nose. Receives: Combination Product: Thymoquinone (0.5%) and Olive oil ointment |
| No intervention | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding crust formation by Endoscopic examination.
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. crust formation will be scored as following:
0: No crust formation observed.
- Thin and easily removable crusts.
- Moderate crust formation, requiring gentle removal.
- Thick and adherent crusts, requiring careful and meticulous removal.
0 is the lowest score meaning no crusts are formed while 3 is the highest score meaning severe crusts are formed.
Measured: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding adhesions by Endoscopic examination.
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. adhesions will be scored as following:
0: No adhesions observed.
- Mild adhesions, limited to small areas.
- Moderate adhesions, affecting larger areas but without complete obstruction.
- Severe adhesions, causing significant obstruction and impaired sinus drainage.
0 is the lowest score meaning no adhesions are formed while 3 is the highest score meaning severe adhesions are formed.
Measured: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding granulation formation by Endoscopic examination
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. Granulations will be scored as following:
0: No granulations observed.
- Mild granulation tissue, with minimal vascularity and minimal elevation.
- Moderate granulation tissue, with moderate vascularity and noticeable elevation.
- Severe granulation tissue, with marked vascularity and significant elevation.
0 is the lowest score meaning no granulation tissue is formed while 3 is the highest score meaning severe granulation tissue are formed.
Measured: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding infection by Endoscopic examination.
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. Infection will be scored as following:
0: No signs or symptoms of infection observed.
- Mild infection, mucopurulent discharge limited to small area of the ethmoidal cavity.
- Moderate infection, mucopurulent discharge filling one sinus.
- Severe infection, mucopurulent discharge filling more than one sinus.
0 is the lowest score meaning there is no infection while 3 is the highest score meaning there is severe infection.
Measured: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Secondary outcomes (1)
Evaluation of symptoms of CRS and NP after Endoscopic Sinus Surgery using SNOT22 questionnaire.
Sinonasal Outcome Test (SNOT-22) Questionnaire will be taken by each participant before and after surgery. The SNOT-22 consists of 22 questions; items 1 to 12 represent the physical problems associated with rhinosinusitis, items 13 to 18 represent the functional limitations, and items 20 to 22 represent the emotional consequences. Each question is scored by the patient from 0 (no problem) to 5 (the problem is as bad as it can be). The overall score can theoretically range from 0 to 110, with higher scores reflecting more severe quality of life impairment as subjectively reported by the patient.
Measured: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Ashraf Abdelhasib, Assiut University
- Investigators
- Mohamed Mostafa Osman, Professor, Study chair, Assiut UniversityAhmed Gamal Sholkamy, Doctor, Study director, Assiut UniversityTarek Ashraf, Doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070311
- Sponsor's protocol ID
- endoscopic sinus surgery
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alobid I, Anton E, Armengot M, Chao J, Colas C, del Cuvillo A, Davila I, Dordal MT, Escobar C, Fernandez-Parra B, Gras-Cabrerizo JR, Ibanez MD, Lluch M, Mateu V, Montoro J, Gili JR, Mullol J, Navarro AM, Pumarola F, Rondon C, Sanchez-Hernandez MC, Sarandeses A, Soler R, Valero AL; Rhinoconjunctivitis Committee; Spanish Society of Allergy and Clinical Immunology; Rhinology and Allergy Commission; Spanish Society of Otorhinolaryngology. SEAIC-SEORL. Consensus Document on Nasal Polyposis. POLINA Project. J Investig Allergol Clin Immunol. 2011;21 Suppl 1:1-58. No abstract available.
PubMed 21714471Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, Bousquet PJ, Brozek G, Bruno A, Dahlen SE, Forsberg B, Gunnbjornsdottir M, Kasper L, Kramer U, Kowalski ML, Lange B, Lundback B, Salagean E, Todo-Bom A, Tomassen P, Toskala E, van Drunen CM, Bousquet J, Zuberbier T, Jarvis D, Burney P. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy. 2011 Sep;66(9):1216-23. doi: 10.1111/j.1398-9995.2011.02646.x. Epub 2011 May 24.
PubMed 21605125Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):565-72. doi: 10.1016/j.jaip.2016.04.012.
PubMed 27393770Bachert C, Bhattacharyya N, Desrosiers M, Khan AH. Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps. J Asthma Allergy. 2021 Feb 11;14:127-134. doi: 10.2147/JAA.S290424. eCollection 2021.
PubMed 33603409Sari H, Karaketir S, Kumral TL, Akgun MF, Gurpinar B, Hanci D, Berkiten G, Uyar Y. The effect of platelet-rich fibrin (PRF) on wound healing, adhesion, and hemostasis after endoscopic sinus surgery in patients with nasal polyposis. Am J Otolaryngol. 2021 Sep-Oct;42(5):103010. doi: 10.1016/j.amjoto.2021.103010. Epub 2021 Mar 29.
PubMed 33862565Soler ZM, Smith TL. Endoscopic sinus surgery checklist. Laryngoscope. 2012 Jan;122(1):137-9. doi: 10.1002/lary.22430. Epub 2011 Nov 17.
PubMed 22095309Loftus CA, Soler ZM, Koochakzadeh S, Desiato VM, Yoo F, Nguyen SA, Schlosser RJ. Revision surgery rates in chronic rhinosinusitis with nasal polyps: meta-analysis of risk factors. Int Forum Allergy Rhinol. 2020 Feb;10(2):199-207. doi: 10.1002/alr.22487. Epub 2019 Nov 21.
PubMed 31752051Testa D, Marcuccio G, Panin G, Bianco A, Tafuri D, Thyrion FZ, Nunziata M, Piombino P, Guerra G, Motta G. Nasal mucosa healing after endoscopic sinus surgery in chronic rhinosinusitis of elderly patients: role of topic alpha-tocopherol acetate. Aging Clin Exp Res. 2017 Feb;29(Suppl 1):191-195. doi: 10.1007/s40520-016-0647-x. Epub 2016 Nov 25.
PubMed 27888473Darakhshan S, Bidmeshki Pour A, Hosseinzadeh Colagar A, Sisakhtnezhad S. Thymoquinone and its therapeutic potentials. Pharmacol Res. 2015 May-Jun;95-96:138-58. doi: 10.1016/j.phrs.2015.03.011. Epub 2015 Mar 28.
PubMed 25829334Melguizo-Rodriguez L, de Luna-Bertos E, Ramos-Torrecillas J, Illescas-Montesa R, Costela-Ruiz VJ, Garcia-Martinez O. Potential Effects of Phenolic Compounds That Can Be Found in Olive Oil on Wound Healing. Foods. 2021 Jul 15;10(7):1642. doi: 10.3390/foods10071642.
PubMed 34359512Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.
PubMed 17903570Kennedy DW. Functional endoscopic sinus surgery. Technique. Arch Otolaryngol. 1985 Oct;111(10):643-9. doi: 10.1001/archotol.1985.00800120037003.
PubMed 4038136
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thymoquinone and Olive Oil on Wound Healing After Endoscopic Sinus Surgery in Patients With Nasal Polyposis
- ClinicalTrials.gov ID
- NCT06070311
- Acronym / sponsor ID
- endoscopic sinus surgery
- Conditions
- Nasal Polyps, Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effect of Thymoquinone (0.5%) and olive oil ointment on Wound healing after Endoscopic sinus surgery.
Detailed description
Endoscopic sinus surgery (ESS) has become a widely accepted procedure for medically refractory chronic rhino sinusitis and nasal polyps. Over 250,000 endoscopic sinus surgeries are performed yearly in the United States alone, however, postoperative complications and disease recurrence requiring revision surgery are reported in 14% to 24% of patients in long-term follow-up.
There is an increasing interest in interventions and therapies targeted at optimizing outcomes and preventing revision surgery which often depends on good wound healing and less adhesion formation.
The choice of appropriate post-surgical topical treatments is important for healing time and for preventing mucosal complications such as adhesions, crusting formation, and atrophy with secondary bacterial and fungal infections in this light this study aims to determine the effect of thymoquinone and olive oil ointment on wound healing after ESS.
Thymoquinone (TQ) is the most abundant constituent of the volatile oil of Nigella sativa seeds and most properties of Nigella sativa are mainly attributed to TQ. Several pharmacological actions and therapeutic potentials of TQ have been investigated including being antioxidant, anti-inflammatory, antihistaminic, antimicrobial, anti-allergic, anti-fibrotic, and anti-cancer.
Olive oil plays an important role in wound healing process due to its content of phenolic compounds accelerating wound healing through their anti-inflammatory, antioxidant, and antimicrobial properties and their stimulation of angiogenic activities required for granulation tissue formation and wound re-epithelialization.
This Double Blinded Randomized Prospective Comparative study will follow patients with nasal polyposis who are indicated for endoscopic sinus surgery at the Department of Otorhinolaryngology in Assiut University Hospital during the period from the 1st of October 2023 to the 31st of September 2025.
At baseline (before surgery), a full medical history, an otorhinolaryngological examination, and pre-operative screening will be performed to ensure eligibility for the study. The patients will be informed about the surgical procedures, the potential risks of the surgery, and the aim and methodology of the study.
(A) Preoperative:
Full history taking:
- Personal History
- History of Sino-nasal symptoms e.g., nasal obstruction, nasal discharge, headache, hyposmia, facial congestion, etc.
- Other ENT symptoms
- General symptoms e.g., asthma, allergy, etc.
- Medical history e.g., steroids, antibiotics, anticholinergics, etc.
- History of nasal surgery
- SNOT 22 questionnaire: To assess preoperative severity of symptoms.
Full medical examination:
- General examination
- Full ENT examination
- Nasal Endoscopy:
- To evaluate polyp size, site, extent, and consistency.
Investigations:
- Routine preoperative investigations: CBC, prothrombin time and concentration
- Radiological investigations: Multi-slice CT scan of the nose and paranasal sinuses axial and coronal cuts without contrast and each patient will be scored according to Lund-Mackay CT scoring.
Preparation of the Thymoquinone and Olive oil ointment:
Thymoquinone Oleaginous base ointment containing olive oil will be prepared for intranasal administration. The ointment will be prepared using the fusion method as follows:
Anhydrous lanolin and white soft paraffin will be melted at 70°C and then olive oil will be added with continuous stirring, Thymoquinone will be added to the congealing mixture as it is being cooled and stirred finally, the congealing mixture is left to cool at room temperature tell solidification and sterilized using UV radiation. The final product will be characterized for spreadability, drug content, drug release and stability.
(B) Intraoperative: All cases will be performed under general anaesthesia and the ESS procedure performed by the senior author is that defined by Kennedy.
Immediately after performing the ESS, Thymoquinone and olive oil Ointment will be applied to fill the ethmoidal and different sinuses cavities of one randomly chosen side of the nose, the selected side will be chosen randomly using the following online randomizer tool:
Randomizer | Random Name/Number Picker - AnnaBet.com Then nasal packing with nasal sponge will be done for both sides.
(C) Postoperative: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery. At these visits, an endoscopic inspection will be performed, and the patients will undergo debridement of the ethmoid cavities when necessary. In addition, endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides regarding adhesions, crust formation, granulation, infection and score each item using the scoring mentioned below.
Crust formation:
0: No crust formation observed.
- Thin and easily removable crusts.
- Moderate crust formation, requiring gentle removal.
- Thick and adherent crusts, requiring careful and meticulous removal.
Adhesions:
0: No adhesions observed.
- Mild adhesions, limited to small areas.
- Moderate adhesions, affecting larger areas but without complete obstruction.
- Severe adhesions, causing significant obstruction and impaired sinus drainage. 3.Granulation:
0: No granulations observed.
- Mild granulation tissue, with minimal vascularity and minimal elevation.
- Moderate granulation tissue, with moderate vascularity and noticeable elevation.
- Severe granulation tissue, with marked vascularity and significant elevation. 4.Infection:
0: No signs or symptoms of infection observed.
- Mild infection, mucopurulent discharge limited to small area of the ethmoidal cavity.
- Moderate infection, mucopurulent discharge filling one sinus.
- Severe infection, mucopurulent discharge filling more than one sinus.
Participants will take the SNOT-22 questionnaire after the operation at the follow up visits to evaluate sino nasal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymoquinone (0.5%) and Olive oil ointment | Active comparator | Combination Product: Thymoquinone (0.5%) and Olive oil ointmentthymoquinone (0.5%) and olive oil ointment will be applied to fill the ethmoidal and different sinuses cavities of one randomly chosen side of the nose. |
| No intervention | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who will be clinically diagnosed and radiologically confirmed cases with bilateral nasal polyposis indicated for Endoscopic sinus surgery.
Key exclusion criteria (11 listed)
- Unfit patient for surgery
- Pregnant and lactating women.
- Patients unwilling to participate.
- Patients who have unilateral disease.
- Patients with a history of the following underlying medical conditions, which are associated with an increased rate of revision surgery, will be excluded from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymoquinone (0.5%) and Olive oil ointmentAlso: thymoquinone and olive oil ointmentPreparation of the Thymoquinone and Olive oil ointment: Thymoquinone Oleaginous base ointment containing olive oil will be prepared for intranasal administration. The ointment will be prepared using the fusion method as follows: Anhydrous lanolin and white soft paraffin will be melted at 70°C and then olive oil will be added with continuous stirring, Thymoquinone will be added to the congealing mixture as it is being cooled and stirred finally, the congealing mixture is left to cool at room temperature tell solidification and sterilized using UV radiation. The final product will be characterized for spreadability, drug content, drug release and stability. | Combination product | Thymoquinone (0.5%) and Olive oil ointment |
Primary outcome
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding crust formation by Endoscopic examination.
Time frame: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. crust formation will be scored as following: 0: No crust formation observed. 1. Thin and easily removable crusts. 2. Moderate crust formation, requiring gentle removal. 3. Thick and adherent crusts, requiring careful and meticulous removal. 0 is the lowest score meaning no crusts are formed while 3 is the highest score meaning severe crusts are formed.
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding adhesions by Endoscopic examination.
Time frame: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. adhesions will be scored as following: 0: No adhesions observed. 1. Mild adhesions, limited to small areas. 2. Moderate adhesions, affecting larger areas but without complete obstruction. 3. Severe adhesions, causing significant obstruction and impaired sinus drainage. 0 is the lowest score meaning no adhesions are formed while 3 is the highest score meaning severe adhesions are formed.
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding granulation formation by Endoscopic examination
Time frame: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. Granulations will be scored as following: 0: No granulations observed. 1. Mild granulation tissue, with minimal vascularity and minimal elevation. 2. Moderate granulation tissue, with moderate vascularity and noticeable elevation. 3. Severe granulation tissue, with marked vascularity and significant elevation. 0 is the lowest score meaning no granulation tissue is formed while 3 is the highest score meaning severe granulation tissue are formed.
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding infection by Endoscopic examination.
Time frame: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. Infection will be scored as following: 0: No signs or symptoms of infection observed. 1. Mild infection, mucopurulent discharge limited to small area of the ethmoidal cavity. 2. Moderate infection, mucopurulent discharge filling one sinus. 3. Severe infection, mucopurulent discharge filling more than one sinus. 0 is the lowest score meaning there is no infection while 3 is the highest score meaning there is severe infection.
1 secondary outcome
Evaluation of symptoms of CRS and NP after Endoscopic Sinus Surgery using SNOT22 questionnaire.
Time frame: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 21714471Alobid I, Anton E, Armengot M, Chao J, Colas C, del Cuvillo A, Davila I, Dordal MT, Escobar C, Fernandez-Parra B, Gras-Cabrerizo JR, Ibanez MD, Lluch M, Mateu V, Montoro J, Gili JR, Mullol J, Navarro AM, Pumarola F, Rondon C, Sanchez-Hernandez MC, Sarandeses A, Soler R, Valero AL; Rhinoconjunctivitis Committee; Spanish Society of Allergy and Clinical Immunology; Rhinology and Allergy Commission; Spanish Society of Otorhinolaryngology. SEAIC-SEORL. Consensus Document on Nasal Polyposis. POLINA Project. J Investig Allergol Clin Immunol. 2011;21 Suppl 1:1-58. No abstract available.
- Background: PubMed 21605125Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, Bousquet PJ, Brozek G, Bruno A, Dahlen SE, Forsberg B, Gunnbjornsdottir M, Kasper L, Kramer U, Kowalski ML, Lange B, Lundback B, Salagean E, Todo-Bom A, Tomassen P, Toskala E, van Drunen CM, Bousquet J, Zuberbier T, Jarvis D, Burney P. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy. 2011 Sep;66(9):1216-23. doi: 10.1111/j.1398-9995.2011.02646.x. Epub 2011 May 24.
- Background: PubMed 27393770Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):565-72. doi: 10.1016/j.jaip.2016.04.012.
- Background: PubMed 33603409Bachert C, Bhattacharyya N, Desrosiers M, Khan AH. Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps. J Asthma Allergy. 2021 Feb 11;14:127-134. doi: 10.2147/JAA.S290424. eCollection 2021.
- Background: PubMed 33862565Sari H, Karaketir S, Kumral TL, Akgun MF, Gurpinar B, Hanci D, Berkiten G, Uyar Y. The effect of platelet-rich fibrin (PRF) on wound healing, adhesion, and hemostasis after endoscopic sinus surgery in patients with nasal polyposis. Am J Otolaryngol. 2021 Sep-Oct;42(5):103010. doi: 10.1016/j.amjoto.2021.103010. Epub 2021 Mar 29.
- Background: PubMed 22095309Soler ZM, Smith TL. Endoscopic sinus surgery checklist. Laryngoscope. 2012 Jan;122(1):137-9. doi: 10.1002/lary.22430. Epub 2011 Nov 17.
- Background: PubMed 31752051Loftus CA, Soler ZM, Koochakzadeh S, Desiato VM, Yoo F, Nguyen SA, Schlosser RJ. Revision surgery rates in chronic rhinosinusitis with nasal polyps: meta-analysis of risk factors. Int Forum Allergy Rhinol. 2020 Feb;10(2):199-207. doi: 10.1002/alr.22487. Epub 2019 Nov 21.
- Background: PubMed 27888473Testa D, Marcuccio G, Panin G, Bianco A, Tafuri D, Thyrion FZ, Nunziata M, Piombino P, Guerra G, Motta G. Nasal mucosa healing after endoscopic sinus surgery in chronic rhinosinusitis of elderly patients: role of topic alpha-tocopherol acetate. Aging Clin Exp Res. 2017 Feb;29(Suppl 1):191-195. doi: 10.1007/s40520-016-0647-x. Epub 2016 Nov 25.
- Background: PubMed 25829334Darakhshan S, Bidmeshki Pour A, Hosseinzadeh Colagar A, Sisakhtnezhad S. Thymoquinone and its therapeutic potentials. Pharmacol Res. 2015 May-Jun;95-96:138-58. doi: 10.1016/j.phrs.2015.03.011. Epub 2015 Mar 28.
- Background: PubMed 34359512Melguizo-Rodriguez L, de Luna-Bertos E, Ramos-Torrecillas J, Illescas-Montesa R, Costela-Ruiz VJ, Garcia-Martinez O. Potential Effects of Phenolic Compounds That Can Be Found in Olive Oil on Wound Healing. Foods. 2021 Jul 15;10(7):1642. doi: 10.3390/foods10071642.
- Background: PubMed 17903570Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.
- Background: PubMed 4038136Kennedy DW. Functional endoscopic sinus surgery. Technique. Arch Otolaryngol. 1985 Oct;111(10):643-9. doi: 10.1001/archotol.1985.00800120037003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Mostafa Osman, Professor study chair
Assiut University
Ahmed Gamal Sholkamy, Doctor study director
Assiut University
Tarek Ashraf, Doctor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Thymoquinone (0.5%) and Olive oil ointment in people with Nasal Polyps and Chronic Sinusitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mostafa Osman, Professor (01005267182, mohamed.ramadan@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding crust formation by Endoscopic examination. (time frame: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06070311, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.