Comparison of the Effectiveness of Sublingual Immunotherapy(SLIT) with Routine Medical Treatment and it's Effect on Serum Level Changes of IL-25 and IL-33 in Patients with Allergic Rhinitis.
The Purpose of this Study was to compare the Efficacy of Sublingual Immunotherapy with Routine Medical Treatment and It's Effects on Serum Levels of Interleukin 25 and 33 in Patients with Allergic Rhinitis.
Design
Parallel, single-blind, randomized clinical trial
Settings and conduct
90 Patients with Allergic Rhinitis that were referred to the manager's clinic of Kashan University of Medical Sciences, Kashan, Iran will be selected in the study.Patients will be divided into two groups. Patients of treatment group will undergo sublingual immunotherapy and patients of control group will use the antihistamine. The severity of the disease and serum levels of interleukin 25 and 33 will be measured at the beginning and at the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having Allergic Rhinitis; age over 12 years.
Exclusion criteria: Any Respiratory and non-respiratory inflammation such as infection, Recent massive surgery, severe pulmonary or renal disease, alcohol abuse, sever addiction, uncontrolled diabetes, cancer, autoimmune diseases
Intervention groups
Patients will be divided into two groups. So patients in the control group will receive classical allergy treatment (oral Cetirizine10 mg daily plus nasal Mometasone spray every 12 hours in every nasal cavity), and patients in the treatment group will use sublingual immunotherapy.
Sublingual immunotherapy with droplets manufactured by Wolwopharm Company of China has been considered as increasing doses to maintenance levels of two drops of 1000 µg sublingual concentrations.
Main outcome variables
The serum levels of interleukins 25 and 33 and the severity of the disease in patients with Allergic Rhinitis will be determined and compared at the beginning and at the end of the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171105037262N1
Registration date:2017-12-01, 1396/09/10
Registration timing:prospective
Last update:2017-12-01, 1396/09/10
Update count:0
Registration date
2017-12-01, 1396/09/10
Registrant information
Name
mohammadhossein pourhanifeh
Name of organization / entity
kashan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 0988
Email address
pourhanifeh-mh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research assistance of kashan university of medical science
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Sublingual Immunotherapy(SLIT) with Routine Medical Treatment and it's Effect on Serum Level Changes of IL-25 and IL-33 in Patients with Allergic Rhinitis.
Public title
Sublingual Immunotherapy Effect on Allergic Rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Allergic Rhinitis
Age over 12 years
Exclusion criteria:
Any Respiratory and non-respiratory inflammation such as infection; Recent Massive Surgery;
Severe Pulmonary or Renal Disease; Alcohol Abuse; Sever Addiction; Uncontrolled Diabetes;
Cancer; Autoimmune diseases
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
After specifying the sample size, the first four blocks of A and B letters are formed (6 blocks). Then, each of the blocks is numbered 1 to 6 and based on the selected numbers from random numbers table, we form a sequence of blocks, in which the letters A and B are located, and then randomly one of the letters are considered as the drug group and the other letter as the control group. This method is referred to as "Termuted Blocked Randomization".
Blinding (investigator's opinion)
Single blinded
Blinding description
Since this is a single-blind study, our blindness would be single-blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Science
Street address
Ghotb-e-Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2017-10-12, 1396/07/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.47
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.1
ICD-10 code description
Allergic rhinitis due to pollen
Primary outcomes
1
Description
Interleukin 25
Timepoint
First and 24 weeks after intervention
Method of measurement
ELISA
2
Description
Interleukin 33
Timepoint
First and 24 weeks after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Disease severity
Timepoint
At the beginning of the study and 24 weeks after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Sublingual immunotherapy with drops manufactured by Wolwopharm in China with doses up to maintenance levels two drops of 1000 micrograms sublingual and for 6 months
Category
Treatment - Drugs
2
Description
Control group: oral Cetirizine 10 mg daily plus nasal spray mometasone every 12 hours a puff in each nasal cavity
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan
Full name of responsible person
Hassan Nikoueinejad
Street address
Ghotb-e-Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
hnikuinejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotb-e-Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?