In this double-blind, clinical trial, the aim of this study is evaluation of Nigella sativa nasal spray effects on chronic rhinosinusitis. Inclusion criteria: patients with chronic rhinosinusitis who have indication for drugs intervention, age between 18 and 72 years.
Exclusion criteria: People who have allergies to herbs; People who do not follow up; People who do not have the consent to participate in the study. The sample size in this study is 72, patients will be allocate randomly in two parallel groups. The intervention group are treated with 2 puffs of nasal spray/ daily, and the placebo group are treated with 2 puffs of sodium chloride nasal spray daily, the length course of treatment is 8 weeks in both groups. After treatment duration, the recovery rate of patients in the two groups is assessed using a pre-prepared questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082712782N17
Registration date:2017-09-23, 1396/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-23, 1396/07/01
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research, School of Medicine, Isfahan University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nigella sativa nasal spray on the treatment of Chronic rhino sinusitis.
Public title
Effect of Nigella sativa Nasal Spray on the Treatment of Patients with Chronic Nasal Sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with chronic rhinosinusitis who have indication for drugs intervention, age between 18 and 72 years.
Exclusion criteria: People who have allergies to herbs; People who do not follow up; People who do not have the consent to participate in the study.
Age
From 18 years old to 72 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jareeb street, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.MUI.REC.1396.30324
Health conditions studied
1
Description of health condition studied
Chronic Rhinosinusitis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
Recovery
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Prepared questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: under Treatment with 2 puffs Nigella sativa Nasal spray / daily
Category
Treatment - Drugs
2
Description
Control group: under treatment with 2 puffs sodium chloride nasal spray /daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Ahmad Rezaeian
Street address
Amin Hospital, Isfahan, Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan University of medical sciences, hezar jareeb, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ahmad Rezaeian
Position
Otorhinolaryngologist/ Assistant professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
dr.ahmadrezaeian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ahmad Rezaeian
Position
Assistant professor of Otorhinolaryngology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
dr.ahmadrezaeian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi kushki
Position
Responsible for research/Master of Science
Other areas of specialty/work
Street address
Alzahra hospital, Sofe street, Isfahan, Iran
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
mehrabi@mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)