This double blind randomized clinical trial with placebo will evaluate the efficacy of Nigella sativa nasal oil drop on chronic rhinosinusitis patients’ quality of life. 52 Patients with eligible criteria (existence of 2 major signs or one major and 2 minor signs of rhinosinusitis in patients; patients have at least 12 consecutive weeks' duration of rhinosinusitis; patients have proved rhinosinusitis by CT-scan; patients are 16 to 65 years old) are divided in two 26 people equal groups by Balanced Block Randomization. Patients in both groups evaluate by major and minor symptoms and signs of rhinosinusitis and SNOT-22 questionnaire before and a week after intervention (day 0 and day 28). The drug group (Nigella sativa oil in sesame oil base) receives three drops in both nostrils twice a day. And the other group receives sesame oil in the same manner. Mean of SNOT-22 result score changes and Changes in Major and minor symptoms and signs of rhinosinusitis in two groups will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202088961N1
Registration date:2013-01-01, 1391/10/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-01, 1391/10/12
Registrant information
Name
Mohammadreza Masroorchehr
Name of organization / entity
Shahid Beheshti University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
m.masroorchehr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical sciences
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Nigella sativa nasal oil drop on chronic rhinosinusitis patients’ quality of life in comparison with placebo.
Public title
The efficacy of Nigella sativa on chronic rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:existence of 2 major signs or one major and 2 minor signs of rhinosinusitis in patients; patients have at least 12 consecutive weeks' duration of rhinosinusitis;patients have proved rhinosinusitis by CT-scan; patients are 16 to 65 years old
exclusion criteria: pregnant patient; patients who are taking daily corticosteroid drugs; immunocompromised patients; patients having fever more than 37.8c; existence of any polyp in the nasal cavity
Drop out: patient drug intolerancy; patient pregnancy when using drug; fever more than 38.5 c when using drug; patient unwillingness to continue participating in clinical trial
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical sciences
Street address
next to Ayatollah Taleghani Hospital, Evin, Shahid Chamran Expressway, Tehran
City
Tehran
Postal code
Approval date
2012-01-08, 1390/10/18
Ethics committee reference number
400/7872
Health conditions studied
1
Description of health condition studied
Chronic Rhinosinusitis
ICD-10 code
J32.9
ICD-10 code description
Sinusitis (chronic) NOS
Primary outcomes
1
Description
SNOT-22 Questionnaire result score
Timepoint
before intervention day(0), and a weak after the end of intervention day(28)