Nigella Sativa for Selected Outcomes in Chronic Rhinosinusitis

Status Completed

Clinical Trial Summary

the study is intended to test the effect of Nigella sativa nasal oil drops on selected outcomes among patients with chronic rhinosinusitis using prospective clinical trial design. To achieve the aim of the current trial the following research hypotheses are postulated: H1. The total severity of symptoms mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total severity of symptoms mean scores of a control group. H2. The total sleep quality mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total sleep quality mean scores of a control group. H3. The total patient satisfaction mean scores of patients with CRS who will use Nigella sativa nasal oil drops will be different from the total patient satisfaction mean scores of a control group.

Clinical Trial Description

The clinical trial will be conducted to examine the effect of administering a daily dose of 100 mg Nigella sativa nasal oil drops for four weeks on selected outcomes which include severity of symptoms, sleep quality and patient satisfaction among patients with chronic rhinosinusitis. The trial will be conducted on 102 adult patients with chronic rhinosinusitis who will be randomly assigned to either a study group (51 participant) who will receive Nigella sativa beside the standard treatment or a control group (51 participant) who will receive the standard treatment only. The current trial will be conducted in the Ear, Nose and Throat (ENT) outpatient clinic at Kasr Al Ainy University Hospital, Cairo, Egypt. Required data will be collected by using the following four tools: (a) Demographic and Medical Data Form (DMDF), (b) Sino-Nasal Outcome Test 22 (SNOT-22), (c) Sleep Quality Scale (SQS) and (d) Treatment Satisfaction Questionnaire for Medication (TSQM). The researcher prepared a flyer that will be handed in for the study group to explain how the oil will be utilized by the participants. The formal initial approval was obtained from Research Ethics Committee at Faculty of Nursing, Cairo University and an official permission was also obtained from the hospital administrators for conducting the trial. The researcher collaborated with Emeritus Professor in Pharmacognosy from the College of Pharmacy for the preparation of N. sativa nasal oil drops from Nigella sativa and Sesame seeds. Thereafter, data collection will be carried out from both groups using the following five steps as follows: recruitment and randomization; interviewing; initial assessment; intervention; follow-up and monitoring. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05494164
Study type	Interventional
Source	Cairo University
Contact
Status	Completed
Phase	N/A
Start date	August 7, 2022
Completion date	May 23, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04131686` - NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis
Completed	`NCT02692794` - Large Scale Cerebral Oximetry During Sinus Endoscopy	N/A
Completed	`NCT01988779` - Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations	Phase 3
Completed	`NCT01254916` - The Sinonasal Outcome Test - 22, Validated for Danish Patients	N/A
Completed	`NCT03614923` - Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)	Phase 2
Completed	`NCT03781804` - Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps	Phase 3
Completed	`NCT01198912` - Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial	Phase 2
Active, not recruiting	`NCT06457100` - Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery	Phase 1/Phase 2
Completed	`NCT03280537` - A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps	Phase 3
Terminated	`NCT02285283` - Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps	Phase 2/Phase 3
Completed	`NCT02307825` - Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy	Phase 4
Completed	`NCT02218307` - The Use of Antibiotic Sinonasal Rinse After Sinus Surgery	Phase 4
Recruiting	`NCT01024075` - Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes	Phase 4
Completed	`NCT01002313` - Effect of Prednisone onTregs and TH17	Phase 1
Completed	`NCT00396162` - Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis	Phase 4
Completed	`NCT03280550` - A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps	Phase 3
Recruiting	`NCT05935683` - Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
Completed	`NCT03478930` - An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps	Phase 3
Completed	`NCT01943370` - Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement	N/A
Completed	`NCT02154555` - A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery	N/A