Chronic Rhinosinusitis Clinical Trial
Official title:
Effect of Nigella Sativa on Selected Outcomes Among Patients With Chronic Rhinosinusitis: Prospective Clinical Trial
NCT number | NCT05494164 |
Other study ID # | 2022-03 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 7, 2022 |
Est. completion date | May 23, 2023 |
Verified date | April 2024 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | May 23, 2023 |
Est. primary completion date | May 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 ?C, - 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | severity of sleep and emotional symptoms as measured by Sino-Nasal Outcome Test 22 (SNOT-22) (sleep and emotional symptoms domains) | 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 eight weeks | |
Secondary | patient satisfaction as measured by Treatment Satisfaction Questionnaire with Medications (TSQM) | Treatment Satisfaction Questionnaire for Medication includes 14 items that assess four key dimensions of treatment satisfaction: (a) effectiveness which includes three items, (b) side Effects which contain five items, (c) convenience that include three items and (d) global Satisfaction that contain three items. Item of TAQM are scaled on 5 or 7 point Likert scale, except one item which is answered with 1= "Yes" or 0= "No". Scores for each domain are calculated independently by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience. | from two to eight weeks |
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