This study aimed to evaluate the allergenicity and immunochemical characterization of five plant pollens
Design
A clinical trial with a healthy control group and a group with seasonal allergies, on 47 patients.
Settings and conduct
The skin test was performed according to international protocols in a clinic under the supervision of asthma and allergy specialist. Then, up to 30 minutes after the test, the patient was examined for immediate hypersensitivity reactions. Other tests, such as electrophoresis and Western blot, were done in the research Laboratory of Birjand University of Medical Sciences,
Participants/Inclusion and exclusion criteria
Residents of Birjand who have referred to asthma and allergy specialist
and Skin Prick test will be performed as a necessary diagnostic method for them and after the necessary explanations, be willing to participate in this research. Diagnosis of atopy in participants was made according to Hanifen and Rajka criteria.
People who, for any reason, do not have a chance to draw blood after Skin Prick test or after test, the research team found that they were taking interfering drugs such as corticosteroids or have blood disorders with CBC and CRP factors or people with infectious diseases, cancer, immunodeficiency, and autoimmune diseases
Intervention groups
The study was performed on people who went to asthma and allergy clinic between the ages of 18 and 40
Main outcome variables
An immediate hypersensitivity reaction to the allergen may occur 15 minutes after the skin test and the patient is monitored for up to 30 minutes after the test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201105049277N1
Registration date:2021-01-31, 1399/11/12
Registration timing:prospective
Last update:2021-01-31, 1399/11/12
Update count:0
Registration date
2021-01-31, 1399/11/12
Registrant information
Name
sajjad chamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 4500
Email address
msnaghizadeh92@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-02-25, 1399/12/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Allergenicity and immunochemical characterization of five plant pollens
Public title
Allergenicity and immunochemical characterization of five plant pollens
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Residents of Birjand who have referred to asthma and allergy specialist
and Skin Prick test will be performed as a necessary diagnostic method for them
And after the necessary explanations, be willing to participate in this research
and diagnosis of atopy in participants was made according to Hanifen and Rajka criteria
Exclusion criteria:
People who, for any reason, do not have a chance to draw blood after a skin test
Or after a blood test, the research team found that they were taking interfering drugs such as corticosteroids
or have blood disorders with CBC and CRP factors
Or people with infectious diseases, cancer or immunodeficiency, and autoimmune diseases
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Brjand University of Medical Sciences
Street address
ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.BUMS.REC.1398.281
Health conditions studied
1
Description of health condition studied
Allergies, allergic rhinitis
ICD-10 code
J30.1
ICD-10 code description
Allergic rhinitis due to pollen
Primary outcomes
1
Description
Skin test, wheal diameter
Timepoint
15 minutes after skin test
Method of measurement
mean wheal diameter greater than 3 mm compared to the negative control is considered as a positive answer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People who have been referred to an allergy clinic and Skin test were performed on them to check for sensitivity to any of the pollen extracts. These people had a positive Skin test for the pollen studied, and a Western blot test will be performed
Category
Diagnosis
2
Description
Control group: People who have been referred to an allergy clinic and Skin Prick test were performed on them to check for allergies to any of the pollen extracts. These people were not allergic to the pollen we studied
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand University of Medical Sciences Clinic
Full name of responsible person
Dr. Mohammad Fereidouni
Street address
Taleghani
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
public-r@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba kazemi
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
public-r@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr mohammad Fereidouni
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9718773958
Phone
+98 56 3243 4500
Email
sajadchamani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sajjad Chamani
Position
Student
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Tohid 12
City
Birjand
Province
South Khorasan
Postal code
9718773958
Phone
+98 56 3243 4500
Email
sajadchamani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sajjad Chamani
Position
Student
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Tohid
City
Birjand
Province
South Khorasan
Postal code
9718773958
Phone
+5632434500
Email
sajadchamani@gmail.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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study will be presented in the article
When the data will become available and for how long
After the article was published in the journal
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use for scientific studies
From where data/document is obtainable
Sajjad Chamani
Phone number: 00989351614683
What processes are involved for a request to access data/document