This randomized, double blind, placebo controlled trial, was conducted to asses the efficacy of Black seed on the treatment of allergic rhinitis. Totally, 66 males and females aged 15–65 years who affected by allergic rhinitis and with no history of medication during last 4 weeks are recruited. The patients are randomly divided to two groups of placebo and intervention. The intervention group receive 40-80 mg/kg/day to maximum 3 gr of Black seed caps prepared from the extract. We measure IgE and Eosinophil count of serum and nasal secretion before and after the intervention. The scoring will be engaged based on severity of symptoms before and after the exposure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806212446N1
Registration date:2010-01-09, 1388/10/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-01-09, 1388/10/19
Registrant information
Name
Soheila Nikakhlagh
Name of organization / entity
Ahwaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 2411
Email address
bioinfo2003@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Ahwaz JondiShapour University of Meical Sciences
Expected recruitment start date
2007-01-14, 1385/10/24
Expected recruitment end date
2009-01-14, 1387/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Nigella Sativa oil in the treatment of Nasal allergic inflammation
Public title
Evaluation of the efficacy of Black seed oil in the treatment of Nasal allergic inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 15–65 years with allergic rhinitis and no consumption of steroids and antihistamines and decongestants during 4 weeks before the study
Exclusion criteria: Patients who use steroids or antihistamines and decongestants during the study
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jondishapour University of Medical Sciences
Street address
Research Deputy, Ahwaz Jondishapour University of Medical Sciences
City
Ahwaz
Postal code
15794
Approval date
2008-04-20, 1387/02/01
Ethics committee reference number
102/د/پ
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.4
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
IgE of serum and nasal secretion
Timepoint
at first and one month later
Method of measurement
Laboratory
Secondary outcomes
1
Description
Eosinophil count of serum and nasal secretion
Timepoint
at first and one month later
Method of measurement
Laboratory
Intervention groups
1
Description
Interventio: 40-80 mg/kg/day to maximum 3 gr of Black seed
Category
Treatment - Drugs
2
Description
Control: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Street address
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy, Ahwaz Jondishapour University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Research Deputy, Ahwaz Jondishapour University of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Ahwaz Jondishapour 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
Ahwaz Jondishapour University of Medical Sciences
Full name of responsible person
Soheila Nikakhlagh
Position
Faculty Member
Other areas of specialty/work
Street address
E.N.T Ward, Imam Khomeini Hospital
City
Ahwaz
Postal code
Phone
+98 61 1336 2411
Fax
Email
Bioinfo2003@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishpour University of Medical Sciences
Full name of responsible person
Soheila Nikaklagh
Position
Superspecialty in E.N.T
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahwaz
Postal code
Phone
+98 61 1336 2411
Fax
Email
Bioinfo2003@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondishapour University of Medical Sciences
Full name of responsible person
Soheila Nikakhlagh
Position
Faculty member
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahwaz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)