The aim of this study is Comparison effect of cetirizine, loratadine and fexofenadine in reducing the symptoms of allergic rhinitis.This is a double blind clinical trial .This study is done on 18 to 60 year old patients with allergic rhinitis.Inclusion criteria:Patients between 18 -60 years old with allergic rhinitis at least for two years.
Exclusion criteria: Paitients with history of hepatitis, renal failure, uncontrolled asthma, acute sinusitis or upper respiratory infection in last two weeks, consumption of corticosteroied, antihistamine and decongestant in last 7 days, pregnant and breast feeding women, using of antipsychotic drugs. Sample size is 90.Patients are divided into three groups:first group are prescribed cetrizine 10 mg daily, second group are prescribed loratadine 10 mg daily and third group are prescribed fexofenadine 60 mg Bid and the paitients are observed for one month. The study started at2015/4/21 and finished 2015/9/22. Primary outcomes are nasal discharge, nasal obstraction, sneeze and nasal itching. Secondry outcomes are and itching in eyes post nasal discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510136252N9
Registration date:2015-11-04, 1394/08/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Soroush Amani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1226 4834
Email address
samani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrecord University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-09-22, 1394/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of cetirizine, loratadine and fexofenadine in reducing the symptoms of allergic rhinitis.
Public title
Comparison effect of cetirizine, loratadine and fexofenadine on allergic rhinitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients between 18 -60 years old with allergic rhinitis at least for two years.
Exclusion criteria: Paitients with history of hepatitis, renal failure, uncontrolled asthma, acute sinusitis or upper respiratory infection in last two weeks, consumption of corticosteroied, antihistamine and decongestant in last 7 days, pregnant and breast feeding women, using of antipsychotic drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sharekord University of Medical Sciences
Street address
Kashani Avenue, Shahrekord
City
Shahrekod
Postal code
8815713471
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
14-8-92
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
nasal discharge
Timepoint
first day,forteenth day,thirtieth day
Method of measurement
clinical evaluation
2
Description
Nasal obstruction
Timepoint
first day,forteenth day,thirtieth day
Method of measurement
clinical evaluation
3
Description
sneezing
Timepoint
first day,forteenth day,thirtieth day
Method of measurement
clinical evaluation
4
Description
nasal itching
Timepoint
first day,forteenth day,thirtieth day
Method of measurement
clinical evaluation
Secondary outcomes
1
Description
post nasal discharge
Timepoint
first day, fourteenth day, thirtieth day
Method of measurement
clinical evaluation
2
Description
itching eyes
Timepoint
first day, fourteenth day, thirtieth day
Method of measurement
clinical evaluation
Intervention groups
1
Description
.Patients are divided into three groups:first group are prescribed cetrizine 10 mg daily, second group are prescribed loratadine 10 mg daily and third group are prescribed fexofenadine 60 mg Bid and the paitients are observed for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Soroush Amani MD
Street address
Shariati Avenue, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmood Mobasheri MD
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
+98 38 3334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
+98 38 3334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashsni Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
+98 38 3334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)