Clinical Trial Without Control Group And Comparisons Of Individuals With Each Other
Settings and conduct
patients with pollen-induced rhinoconjunctivitis were treated with 3 intralymphatic inguinal injections of Greer 1000 SQ-U Salsola Kali Allergen Extract With 4 Weeks Interval . Clinical effects (SNOT22 Questionnaire), safety and circulating Salsola Kali Specific IgE were assessed before, 4 weeks after treatment and at the End Of The Consecutive Pollen Season And Comparisons Of Individuals With Each Other.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Patients With Seasonal Or Perennial Allergic Rhinitis That Have Aggravated Symptoms From Mid Summer till Mid Autumn For At Least Two Years…
2) Age :15-68 Years
3)Positive Skin Prick Test Response, Defined As Wheal Diameter ≥3 mm
, To Salsola Kali
4)A Clinical History Of Rhinoconjunctivitis That Remains Troublesome
Despite Treatment With Either Antihistamines Or Nasal Corticosteroids During The Weed Pollen Season
5) The Ability To Give Informed Consent And Comply With Study Procedures
Exclusion criteria
1. Previous Allergen Immunotherapy
2. History Of Asthma
3. At Screening Visit, Current Symptoms Of, Or Treatment For, Upper Respiratory Tract Infection
4. History Of Life-Threatening Anaphylaxis Or Angioedema
5. Ongoing Systemic Immunosuppressive Treatment
6. The Presence Of Any Medical Condition Such As Malignancy, Autoimmune Disease ,Immunodeficiency Or Any Other Chronic Disease
7.History Of Drug Consumption Such As ACE_Inhibitor, Beta Blocker, MAO Inhibitor
8. Pregnancy
Intervention groups
18 to 65 Year Old Patients With Persistent Allergic Rhinitis
Main outcome variables
Allergic Rhinitis Symptom; Quality Of Life; Adverse Reaction; Salsola Specific IgE
General information
Reason for update
Acronym
ILIT
IRCT registration information
IRCT registration number:IRCT20161206031256N2
Registration date:2018-03-02, 1396/12/11
Registration timing:retrospective
Last update:2018-03-02, 1396/12/11
Update count:0
Registration date
2018-03-02, 1396/12/11
Registrant information
Name
Maryam Khoshkhui
Name of organization / entity
Mashhad university
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2770
Email address
khoshkhuim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
2017-04-03, 1396/01/14
Actual recruitment end date
2017-06-20, 1396/03/30
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Intralymphatic Allergen Immunotherapy in patients with Allergic Rhinitis
Public title
Effects of Intralymphatic Allergen Immunotherapy in treatment of allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Seasonal or Perennial Allergic Rhinitis
Aggravated symptoms from mid Summer till mid Autumn for at least two years
Age :15-65 years
Positive Skin Prick Test response to Salsola Kali
Symptoms remain troublesome despite treatment
The ability to comply with study procedures
Exclusion criteria:
Past history of Autoimmune Diseases
Ongoing Systemic Immunosuppressive treatment.
The presence of Pregnancy
The presence of Immunodeficiency
The presence of Allergic Asthma
The presence of Heart Diseases
Ongoing Beta Blocker or ACE inhibitors drug usage
The presence of Malignancy
The presence of any chronic diseases
Current symptoms of Upper Respiratory Tract Infection
History of life-threatening Anaphylaxis or Angioedema
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Actual sample size reached:
15
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
Mashahd University of Medical Sciences
Street address
Ghoreishi building Ethics Committee of Mashahd University of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9175711111
Approval date
2017-03-21, 1396/01/01
Ethics committee reference number
IR.MUMS.fm.REC.1395.547
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
Clinical Symptoms, Drug Usage, Skin Prick Test, Specific IgE
Timepoint
Befor The Trial
Method of measurement
Sign And Symptoms, Antiasthmatic Drugs Usage, Skin Prick Test, Peakflowmetry and Specific IgE
Secondary outcomes
1
Description
Clinical symptoms, drug usage, specific IgE
Timepoint
One month after end of treatment
Method of measurement
Physical examination and peakflowmetry
Intervention groups
1
Description
3 intralymphatic inguinal injections under the guide of sonography( 1000 SQ-U Salsola-pollen extract within 4 weeks interval).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital, Allergy Clinic
Full name of responsible person
Nasrin Sadat Motevalli Haghi
Street address
Ghaem Hospital, Shariati Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175711111
Phone
+98 51 3801 2829
Email
dr.haghi@yahoo.com
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 building, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9175711111
Phone
+98 51 3844 5019
Email
khoshkhuim@mums.ac.ir
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
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
Mashhad Unevesity of Medical Science
Full name of responsible person
Nasrin Sadat Motevalli Haghi
Position
fellow in training immunology and allergy
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Allergy Research Center, Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9175711111
Phone
+98 51 3801 2829
Fax
Email
dr.haghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences, Allergy Research center
Full name of responsible person
Maryam Khoshkhui
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Allergy Research Center, Ghaem Hospital , Ahmadabad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175711111
Phone
+98 51 3801 2829
Fax
Email
khoshkhuim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The University of Mashhad
Full name of responsible person
Nasrin sadat motevalli haghi
Position
fellow in training
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Ghaem Hospital, Shariati Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175711111
Phone
+98 51 3846 4889
Fax
Email
DR.HAGHI@YAHOO.COM
Web page address
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
intralymphatic allergen immunotherapy
When the data will become available and for how long
6 month after study
To whom data/document is available
every one
Under which criteria data/document could be used
choosing new management
From where data/document is obtainable
internet searching
What processes are involved for a request to access data/document