Comparison the effect of Azelastine spary with budesonide spary in patient with allergic rhinits that admitted to khatam alanbia hospital in Zahedan in2017
Determination of the effect of Azelastine spary with budesonide spary in patient with allergic rhinits that admitted to khatam alanbia hospital in Zahedan in2017
Design
in this study 80 patients ranges 5-18, 18-40 and more than 40 years will be divided in two groups randomly and be treated with budesonide and azalestin spray. groups are matched for age and sex,
Settings and conduct
This study was performed as a clinical trial in the ENT department of Khatam-ol-Anbia Hospital in Zahedan. The study population included all referral patients who were treated by an ENT specialist during the year 96, according to history and clinical findings with the diagnosis of allergic rhinitis.
Patients who are referred to the ENT department for allergic rhinitis and treated Patients divided to the two treatment groups are assigned to the first group with azelaestin spray and the second group is given with budesonide spray. Patients will evaluated for five signs.
Participants/Inclusion and exclusion criteria
Major inclusion is patients with allergic rhinitis and exclusions are pregnancy, infection, asthma and adenoid hypertrophy.
Intervention groups
Intervention group includes volunteers who received azalestin spray(allergodil 0.1% 125microgram), Intervention group includes volunteers who received budesonide spray(FRENOLYN inhaler 200micorgram/dose 200 dose) and control group includes volunteers who received placebo
Main outcome variables
treatment status of allergic rhinitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170806035536N2
Registration date:2018-04-18, 1397/01/29
Registration timing:retrospective
Last update:2018-04-18, 1397/01/29
Update count:0
Registration date
2018-04-18, 1397/01/29
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4245 0395
Email address
mansour.sh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Azelastine spary with budesonide spary in patient with allergic rhinits that admitted to khatam alanbia hospital in Zahedan in2017
Public title
omparison the effect of Azelastine spary with budesonide spary in patient with allergic rhinits
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the absence of patients with non-allergic rhinitis
pregnant women
those with acute or chronic upper respiratory infections
asthmatic patients
adenoid hypertrophia
Exclusion criteria:
those who have been ill during the study for any reason Did not complete the administration of the prescriptive or incomplete treatment
cases of seasonal allergic rhinitis
patients exposed to inhaled chemicals
Age
From 5 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is such that after the arrival of patients, patients are classified into triple blocks and fall into one of two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethis committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
ir.zaums.rec.1396.230
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
j30.2
ICD-10 code description
Other seasonal allergic rhinitis
Primary outcomes
1
Description
Recovery situation
Timepoint
30 days after the first visit
Method of measurement
The symptoms of the disease that the patient is referring to include nasal congestion, itching of the eyes, and lips.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group includes volunteers who received azalestin spray
Category
Treatment - Drugs
2
Description
Intervention group: volunteers who received budesonide spray
Category
Treatment - Drugs
3
Description
Control group: control group includes volunteers who received placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Ol-Anbia Hospital
Full name of responsible person
Dr Reza Ghariby
Street address
Khatam-Ol-Anbia Hospital, Jam e Jam Avenue, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Hushang Rafighdust
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Ghariby
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Ghariby
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Ghariby
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743175
Phone
+98 54 3329 5718
Email
khatamhospital_zah@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
proposal
When the data will become available and for how long
2018
To whom data/document is available
Public population
Under which criteria data/document could be used
In order to do research
From where data/document is obtainable
Zahedan University of Medical Sciences website
What processes are involved for a request to access data/document
Depending on the site, you can see the documentation.