Overview

Nigella Sativa for Selected Outcomes in Chronic Rhinosinusitis

Status:
Enrolling by invitation
Trial end date:
2023-02-07
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cairo University
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.