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 fluticasone propionate.

Protocol summary

Summary
In this study patients 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 will make an interview with patients and will explain the situations of the study to 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 by use of anti-histamine (Fexofenadine) and Intranasal corticosteroid (fluticasone propionate). Blood samples will be transferred to CBC vials containing anti coagulant (EDTA) and then will be transferred to the laboratory as quickly as possible. Then, using RNA extraction kit, RNA will be extracted from peripheral blood cells of sample bloods. Next by use of Reverse transcriptase enzyme, the extracted RNA will be transcribed to complementary DNA (cDNA) and then they will be stored in -20 ºC until the last step. Then the level of expression of transcription factors gene: GATA-3, Foxp3 and RORγt in all prepared cDNA will be measured, in relative measurement, by use of Real-time PCR and sybergreen method.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050233622N2
Registration date: 2017-07-06, 1396/04/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-06, 1396/04/15
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
2017-05-31, 1396/03/10
Expected recruitment end date
2017-08-03, 1396/05/12
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 fluticasone propionate.
Public title
Effect of Fexofenadine and fluticasone propionate on the level of transcription factors: GATA-3، RORγt and FOXP3 in allergic rhinitis patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: 1- People enter to the study should be at the age of 18 to 60 years, 2- They have to study and signature the testimonial before entrance to the study, 3- lack of abnormality in nasal anatomy, 4- having rhinitis symptoms which is confirmed by specialist physician, 5- not being suffered from: asthma, infectious disease, underlying diseases such as diabetes and chronic inflammatory diseases, 6- In addition, pregnant women, people above 65 and those people who suffer from rhinitis because of Senility will not enter the study. Exclusion criteria: 1- People suffering from infectious diseases or common cold during the period of study, 2- patients taking drugs other than drugs that must consume according to the research plan, during Performance of the project, 3- patients who have a fungal, viral or bacterial disease during the t curse of study, 4- patients who do not follow the recommended instructions. All these people will be excluded from the study.
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: 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
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Vice Chaneller for Research and Technology, building Number 2 of Kermanshah University of Medical Sciences, Beheshti Bolvard, Kermanshah
City
Kermanshah
Postal code
6714673159
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
KUMS.REC.1395.756

Health conditions studied

1

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

Primary outcomes

1

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

2

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

3

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

Secondary outcomes

empty

Intervention groups

1

Description
Drug administration: Fexofenadine: 1 tablet/ day Fluticasone propionate: one puff nasal spray into each nostril/ 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, Kermanshah University of Medical Sciences
Full name of responsible person
Koorosh Hamzehee
Street address
Vice Chancellor for Research and Technology, Building NO. 2 of Kermanshah University of Medical Sciences, 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, Kermanshah 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
School of Medicine, Kermanshah University of Medical Sciences
Full name of responsible person
Ali Gorgin Karaji
Position
University Lecturer (Associate Professor)
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.comali4459@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Medicine, 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
Atefe Mehrmanesh
Position
MSc Student
Other areas of specialty/work
Street address
School of Medicine, Daneshgah Blv., Danesgah Square, Kermnanshah
City
Kermnanshah
Postal code
6714869914
Phone
Fax
Email
atefe.mehrmanesh@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...