An interventional study of Thymoquinone (0.5%) and Olive oil ointment in Nasal Polyps and Chronic Sinusitis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
This study aims to determine the effect of Thymoquinone (0.5%) and olive oil ointment on Wound healing after Endoscopic sinus surgery.
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:
Full medical examination:
Nasal Endoscopy:
Investigations:
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.
Adhesions:
0: No adhesions observed.
0: No granulations observed.
0: No signs or symptoms of infection observed.
Participants will take the SNOT-22 questionnaire after the operation at the follow up visits to evaluate sino nasal symptoms.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Combination Product: Thymoquinone (0.5%) and Olive oil ointment
no intervention
Drug pages: Thymoquinone · Olive Oil
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.
Also known as: thymoquinone and olive oil ointment
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. 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.
Time frame: 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. 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.
Time frame: 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. 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.
Time frame: 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. 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.
Time frame: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
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.
Time frame: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
No study locations are listed for this record.
Start is estimated for Oct 2023; primary completion for Sep 2025, 23 months later.
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Studies of the drugs tested here: Thymoquinone · Olive Oil