The aim of this study was to determine the effect of sublingual immunotherapy on clinical symptoms and gene expression level of Foxp3 regulatory T cells, IL-10 and Transforming Growth Factor Beta and IL -17 compared with placebo in allergic rhinitis sensitive to mites. The main inclusion criteria, suffering from perennial allergic rhinitis and being sensitive to mites and the main exclusion criteria are having history of autoimmune disease, consumption of corticosteroids or immunosuppressive drugs and allergic asthma. . After obtaining parental consent, randomly divided into two groups treated with a condensed drops of mites or placebo. Before starting treatment, at regular intervals and after 6 months of treatment, based on standard questionnaires and clinical examination, the severity and extent of anti-allergy drugs were recorded. At the beginning and end of the project in 10 ml heparin blood brachial vein taken from the patient's immunological tests to check the levels of gene expression changes in regulatory T cells.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042323235N9
Registration date:2017-05-10, 1396/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-10, 1396/02/20
Registrant information
Name
Farahzad Jabbari Azad
Name of organization / entity
Allergy Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2770
Email address
jabbarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical and immunological efficacy of sub lingual immunotherapy in patients with allergic rhinitis sensitive to mite
Public title
Sub lingual immunotherapy of Nasal allergies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:approved clinical perennial allergic rhinitis and laboratory diagnosis;the desire of patients to drug treatment and participation in the project
Exclusion criteria: Suffering from seasonal allergic rhinitis, a history of autoimmune disease, Consumption of corticosteroids or immunosuppressive drugs, pregnancy, allergic asthma, malnutrition
Age
From 5 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitie of Mashahd University of Medical Sciences
Street address
Ghoreishi building Ethics Committee of Mashahd University of Medical Science
City
Mashhad
Postal code
Approval date
2010-10-27, 1389/08/05
Ethics committee reference number
IR.MUMS.REC.1389.82
Health conditions studied
1
Description of health condition studied
Perennial allergic rhinitis
ICD-10 code
J30.3
ICD-10 code description
Other allergic rhinitis
Primary outcomes
1
Description
Clinical symptoms of allergic rhinitis
Timepoint
After six month
Method of measurement
questionnaire
Secondary outcomes
1
Description
FOXP3 gene expression
Timepoint
After six month
Method of measurement
Real-Time PCR
2
Description
Interlukin-10
Timepoint
After six month
Method of measurement
Real-Time PCR
3
Description
Tumor Groeth Factor-B
Timepoint
After six month
Method of measurement
Real-Time PCR
4
Description
Interlukin-17
Timepoint
After six month
Method of measurement
Real-Time PCR
Intervention groups
1
Description
In Intervention group received Extract drops of mite via sublingual administration for 6 months
Category
Treatment - Drugs
2
Description
In control group received placebo via for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy Clinic Ghaem Hospital
Full name of responsible person
Dr Farahzad Jabbari Azad
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi,Daneshgah Ave, Mashhad
City
Mashhad
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, Mashhad 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
Mashad Universityof Medcal Sciences
Full name of responsible person
Homa sadri
Position
Medical student
Other areas of specialty/work
Street address
Allergy Reaserch Center, Ghaem Hospital, Ahmad Abad Street, Mashhad
City
Mashhad
Postal code
Phone
+98 518012770
Fax
Email
homasadri7@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allergy Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Farahzad Jabbari Azad, MD
Position
Associate Professor
Other areas of specialty/work
Street address
Allergy Research Center, Ghaem Hospital , Ahmadabad Ave, Mashhad
City
Mashhad
Postal code
Phone
+98 518012770
Fax
Email
jabbarif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Homa Sadri
Position
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
Fax
Email
homasadri7@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)