Nigella Sativa for Selected Outcomes in Chronic Rhinosinusitis

NCT ID: NCT05494164

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-07
• Study Completion Date: 2023-05-23

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.

Conditions

Chronic Rhinosinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group

Nigella sativa nasal oil drops

Group Type: EXPERIMENTAL

Nigella sativa nasal oil drops

Intervention Type: OTHER

in addition to the standard treatment, the study group will receive one nasal drop of the prepared N. sativa nasal oil drops in each nostril twice daily which are equivalent to a daily dose of 100 milligram of a pure N. sativa oil for four weeks. N. sativa oil was prepared from N. sativa seeds and it was mixed in Sesame oil with a ratio of 1 to 1. The prepared drops will then be placed in dark containers with a specific dropper. Each participant will be instructed regarding the dose, proper position and steps, assisted by a flyer which will be developed by the researcher.

standard treatment

Intervention Type: DRUG

intranasal corticosteroids in addition to nasal irrigation with sea water; for patients with allergy the standard treatment is oral antihistamines with or without oral corticosteroids.

Control group

standard treatment

Group Type: OTHER

standard treatment

Intervention Type: DRUG

intranasal corticosteroids in addition to nasal irrigation with sea water; for patients with allergy the standard treatment is oral antihistamines with or without oral corticosteroids.

Interventions

Nigella sativa nasal oil drops

in addition to the standard treatment, the study group will receive one nasal drop of the prepared N. sativa nasal oil drops in each nostril twice daily which are equivalent to a daily dose of 100 milligram of a pure N. sativa oil for four weeks. N. sativa oil was prepared from N. sativa seeds and it was mixed in Sesame oil with a ratio of 1 to 1. The prepared drops will then be placed in dark containers with a specific dropper. Each participant will be instructed regarding the dose, proper position and steps, assisted by a flyer which will be developed by the researcher.

Intervention Type: OTHER

standard treatment

intranasal corticosteroids in addition to nasal irrigation with sea water; for patients with allergy the standard treatment is oral antihistamines with or without oral corticosteroids.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Reham Samir Fatehallah

Assistant Lecturer at Medical-Surgical Nursing, Faculty of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reham S. Fatehallah, Master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Bassamat O. Ahmed, Doctorate

Role: STUDY_DIRECTOR

Cairo University

Hanan A. Al Sebaee, Doctorate

Role: STUDY_DIRECTOR

Cairo University

Fathy M. Soliman, Doctorate

Role: STUDY_DIRECTOR

Cairo University

Adel El-Antably, Doctorate

Role: STUDY_DIRECTOR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

2022-03

Identifier Type: -

Identifier Source: org_study_id