Clinical trial NCT05494164: Nigella Sativa for Selected Outcomes in Chronic Rhinosinusitis
Official title: Effect of Nigella Sativa on Selected Outcomes Among Patients With Chronic Rhinosinusitis: Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Keywords: Nigella sativa
chronic rhinosinusitis
nasal oil drops
outcomes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients from 18 to 60 years old,
* able to communicate,
* having a confirmed diagnosis of CRS by signs and symptoms and meeting the criteria of having twelve consecutive weeks or longer of two or more of the following signs and symptoms will be recruited for the current trial: (a) mucopurulent drainage, (b) nasal obstruction/congestion, (c) facial pain-pressure-fullness and (d) decreased sense of smell; and one or more of the following signs and symptoms: (a) purulent mucus or edema in middle meatus or anterior ethmoid region or (b) radiographic imaging showing sinus inflammation.

Exclusion Criteria:

* Pregnancy,
* lactating mothers,
* immunodeficiency,
* scheduled for surgical management for nasal polyposis,
* fever more than 37.8 ﹾC,
* patients with coagulation disorders or using anticoagulants,
* patients taking non-potassium sparing diuretics,
* patients allergic to N. sativa (patients reactive to sensitivity test)
* patients using any type of natural products as a complementary therapy at the time of the trial.

Primary outcomes:
measure: Severity of physiological symptoms as measured by Sino-Nasal Outcome Test 22 (SNOT-22)
timeFrame: from two to four weeks
measure: Sleep quality as measured by Sleep Quality Scale (SQS)
timeFrame: from two to four weeks
Secondary outcomes:
measure: severity of sleep and emotional symptoms as measured by Sino-Nasal Outcome Test 22 (SNOT-22) (sleep and emotional symptoms domains)
timeFrame: from two to eight weeks
measure: patient satisfaction as measured by Treatment Satisfaction Questionnaire with Medications (TSQM)
timeFrame: from two to eight weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Reham S. Fatehallah, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Bassamat O. Ahmed, Doctorate
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Hanan A. Al Sebaee, Doctorate
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Fathy M. Soliman, Doctorate
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Adel El-Antably, Doctorate
role: STUDY_DIRECTOR
References: