Nigella Sativa for Selected Outcomes in Chronic Rhinosinusitis

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.

Conditions

• Chronic Rhinosinusitis

Interventions

OTHER

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.

DRUG

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.

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• Reham S. Fatehallah, Master · Cairo University

• Bassamat O. Ahmed, Doctorate · Cairo University

• Hanan A. Al Sebaee, Doctorate · Cairo University

• Fathy M. Soliman, Doctorate · Cairo University

• Adel El-Antably, Doctorate · Cairo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-07

Primary Completion

2023-05-23

Completion

2023-05-23

Countries

• Egypt

Study Locations