1. Home
  2. Approved trials
  3. » فارسی

A comparison survey of GATA-3, RORγt and FOXp3 genes expression levels in peripheral blood cells of rhinitis patients, before and after treatment with fexofenadine and budesonide.

Protocol summary

Summary
In this study people who have clinical sign and symptoms of rhinitis (nasal congestion, rhinorrhea, sneezsing, itchy nose, headache, earache, Itchy throat, snoring or postnasal drip) after diagnosis by specialist of allergy will enter the study. Next we make an interview with patients and we explain the situations of the study for the patients. If patients Satisfy and desire the study, they will enter the study. From each patient, before treatment and after one month treatment, 5 ml blood will be taken. Treatment will be done in one month with anti-histamine (Fexofenadine) and Intranasal corticosteroid (budesonide). Blood samples will transfer to CBC vials containing anti coagulant (EDTA) and quickly will transfer to the lab. Next, using RNA extraction kit, RNA will be extracted from peripheral blood cells of taken bloods. Then, using Reverse transcriptase enzyme, extracted RNA will be transcribed to cDNA and will be store in -20 ºC until real time test. Then the level of expression of transcription factors, GATA-3، RORγt and Foxp3 in blood samples will be measured, in relative measurement, by use of Real-time PCR and sybergreen method.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017042433622N1
Registration date: 2017-05-16, 1396/02/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-16, 1396/02/26
Registrant information
Name
Ali Gorgin Karaji
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 833427461821
Email address
agorgin@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research and Technology, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-05-13, 1396/02/23
Expected recruitment end date
2017-07-14, 1396/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison survey of GATA-3, RORγt and FOXp3 genes expression levels in peripheral blood cells of rhinitis patients, before and after treatment with fexofenadine and budesonide.
Public title
Effect of Fexofenadine and budesonide on the level of transcription factors: GATA-3، RORγt and FOXP3 in allergic rhinitis patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: the age of man and women between 18 to 60, Signature the testimonial by the patients before entrance to the study, having rhinitis symptoms which is confirmed by specialist physician, lack of abnormality in nasal anatomy, not being suffered from: asthma, infectious disease, underlying diseases such as diabetes and chronic inflammatory diseases. In addition, pregnant women, people above 65 and those people who suffer from rhinitis because of Senility will not enter the study. Exclusion criteria: People suffering from infectious diseases or common cold and patients taking drugs other than drugs that must consume according to the research plan, during Performance of the projectو will be excluded. In addition, patients who have a fungal, viral or bacterial disease during the study and patients who do not follow the recommended instructions will be excluded.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
No. 2 bulding of KUMS, Beheshti Bolvard, Kermanshah
City
Kermanshah
Postal code
6714673159
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
KUMS.REC.1395.716

Health conditions studied

1

Description of health condition studied
Rhinitis
ICD-10 code
J30-J31
ICD-10 code description
Vasomotor and allergic rhinitis and Chronic rhinitis, nasopharyngitis and pharyngitis

Primary outcomes

1

Description
GATA3, FOXP3 and RORgt
Timepoint
Befor treatment and After one month treatment
Method of measurement
Relative expression of GATA3, FOXP3 and RORgt measured by Real-time PCR

Secondary outcomes

empty

Intervention groups

1

Description
Fexofenadine: One tablet per day Budesonide: One Puff per day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Kermanshahi Hospital
Full name of responsible person
Dr. Seyed Hamid Reza Mortazavi
Street address
Dr Kermanshahi Hospital, Helal Ahmar Crossroad, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Behrooz Hamzeh
Street address
NO. 2 Bulding of Vice Chancellor for Research and Technology, Shahid Beheshti Blv. Kermanshah, Iran
City
Kermanshah
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 and Technology
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
School of Medicine, Kermanshah University of Medical Sciences
Full name of responsible person
Ali Gorgin Karaji
Position
University Lecturer
Other areas of specialty/work
Street address
School of Medicine, Daneshgah Blv. Daneshagh Square, Kermanshah
City
Kermnanshah
Postal code
6714869914
Phone
+98 833427461821
Fax
+98 83 3427 6477
Email
ali4459@gmail.com; ali4459@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Gorgin Karaji
Position
Ph.D.
Other areas of specialty/work
Street address
School of Medicine, Daneshgah Blv., Daneshgah Square, Kermanshah
City
Kermnanshah
Postal code
6714869914
Phone
+98 833427461821
Fax
+98 83 3427 6477
Email
ali4459@gmail.com; ali4459@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Medicine, Kermanshah University of Medical Sciences
Full name of responsible person
Elham Bagherinia
Position
MSc Student
Other areas of specialty/work
Street address
School of Medicine, Daneshgah Blv., Danesgah Square, Kermnanshah
City
Kermnanshah
Postal code
6714869914
Phone
+98 833427461821
Fax
+98 83 3427 6477
Email
e.bagherinia@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...