Nigella Sativa for Selected Outcomes in Chronic Rhinosinusitis

NCT05494164 | Completed DMC

• 1 other identifier: 2022-03
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis

Keywords

Nigella sativa; chronic rhinosinusitis; nasal oil drops; outcomes

Outcome Measures

Primary Outcomes (2)

• Severity of physiological symptoms as measured by Sino-Nasal Outcome Test 22 (SNOT-22)

  SNOT-22 consists of 22 items that measure four domains as follows: (a) nasal symptoms domain that contains eight items, (b) otologic symptoms domain which includes four items, (c) sleep symptoms domain which includes seven items and (d) emotional symptoms domain that contains three items. SNOT-22 is scored using a Likert scale where 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem" and 5="Problem as bad as it can be". The overall scores of the SNOT-22 is ranged from 0 to 110 with higher scores suggesting symptom severity.

  from two to four weeks

• Sleep quality as measured by Sleep Quality Scale (SQS)

  Sleep Quality Scale (SQS) consists of 28 items, which evaluate six domains of sleep quality as follows: (a) daytime dysfunction/symptoms which contain twelve items, (b) restoration after sleep which include four items, (c) difficulty falling asleep that contain four items, (d) difficulty getting up that include three items, (e) difficulty in maintaining asleep which contain two items and (f) satisfaction with sleep which include three items. Sleep Quality Scale is scored through a four-point, Likert-type scale; (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"). Scores on items belong to factors 2 and 5 (restoration after sleep and satisfaction with sleep) are reversely scored. Total scores are ranged from 0 to 84, with higher scores denoting more acute sleep problems.

  from two to four weeks

Secondary Outcomes (2)

• severity of sleep and emotional symptoms as measured by Sino-Nasal Outcome Test 22 (SNOT-22) (sleep and emotional symptoms domains)

  from two to eight weeks

• patient satisfaction as measured by Treatment Satisfaction Questionnaire with Medications (TSQM)

  from two to eight weeks

Study Arms (2)

Study group

EXPERIMENTAL

Nigella sativa nasal oil drops

Other: Nigella sativa nasal oil drops; Drug: standard treatment

Control group

OTHER

standard treatment

Drug: standard treatment

Interventions

Nigella sativa nasal oil drops 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.

Study group

standard treatment 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; Study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Officials

• Reham S. Fatehallah, Master

  Cairo University

  PRINCIPAL INVESTIGATOR

• Bassamat O. Ahmed, Doctorate

  Cairo University

  STUDY DIRECTOR

• Hanan A. Al Sebaee, Doctorate

  Cairo University

  STUDY DIRECTOR

• Fathy M. Soliman, Doctorate

  Cairo University

  STUDY DIRECTOR

• Adel El-Antably, Doctorate

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants in both groups will be blinded to which treatment arms they will be assigned to till the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at Medical-Surgical Nursing, Faculty of Nursing

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: August 7, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)