Improving the quality of life for patients with chronic idiopathic urticaria
Design
A Randomized Clinical Trials non Blinded - Two arm study with Control group receiving standard treatment.
Settings and conduct
5 cc blood is taken from the brachial vein centrifuged at 2000 rpm and 0.1 cc of the serum is subcutaneously injected into the forearm. Positive control of histamine (0.1 mg / ml) and negative control of 0.1 cc of normal saline will be injected in the same area at a distance of 5 cm from each other. In the event of a rupture of rat (more than 1.5 mm in diameter than normal saline (30 minutes after the test), a positive autologous serum test is assumed.
During the study, patients will be allowed to use oral short-acting antihistamines only if necessary and in case of obesity.
Participants/Inclusion and exclusion criteria
inclusion :
History of hives at least 6 weeks
Exclusion :
Finding a specific cause (physical urticaria)
Pregnancy
Lactation
Don't use a safe contraceptive method
Severe systemic illness
Taking anticoagulant drugs
Taking systemic corticosteroids during the last 6 weeks
Taking immuno suppressor drugs during the last 6 weeks
Intervention groups
Intervention group:
After separating the patient's serum, 2.5 cc of the patient's serum will be injected deep into the muscle (arm or hips) with syringe number 22. Injections will be on a weekly basis for up to 9 weeks. The patient will be re-evaluated at weeks 12 and 16.
control group :
Will be treated by oral antihistamines .As a placebo 3 cc normal saline will be injected deep muscle.
Main outcome variables
Quality of Life ; Hives severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171222037986N2
Registration date:2019-01-15, 1397/10/25
Registration timing:retrospective
Last update:2019-01-15, 1397/10/25
Update count:0
Registration date
2019-01-15, 1397/10/25
Registrant information
Name
Rasol Nasiri Kalmarzi
Name of organization / entity
Kurdistan university of medical scions
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 0524
Email address
rnasiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-09-22, 1393/06/31
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
2014-12-01, 1393/09/10
Actual recruitment end date
2016-03-18, 1394/12/28
Trial completion date
2016-09-20, 1395/06/30
Scientific title
Effects of Serum Autologous Therapy in patients with Idiopathic Chronic Urticaria
Public title
Serum Autologous Therapy in Idiopathic Chronic Urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of hives at least 6 weeks
Exclusion criteria:
Finding a specific cause (physical urticaria)
Pregnancy
Lactation
Don't use a safe contraceptive method
Severe systemic illness
Taking anticoagulant drugs
Taking systemic corticosteroids during the last 6 weeks
Taking immuno suppressor drugs during the last 6 weeks
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocking
Group A (intervention)
Group B (control)
BABA ABAB BAAB ABBA BBAA
BABA ABBA BBAA AABB BABA
BAAB ABAB BABA ABBA ABAB
AABB
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Science
Street address
Kurdistan University of Medical Sciences Vice Chancellor in Research Affair, Pasdaran Ave., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
13446ـ66177
Approval date
2014-12-01, 1393/09/10
Ethics committee reference number
با توجه به اینگه در سال 1393 کد اخلاق صادر نمیشد نامه تاییده به ایمیل مرکز ارسال میگردد.
Health conditions studied
1
Description of health condition studied
Idiopathic Chronic Urticaria
ICD-10 code
L50.9
ICD-10 code description
Urticaria, unspecified
Primary outcomes
1
Description
Quality of Life
Timepoint
Weekly to Week 9, Week 12 and Week 16
Method of measurement
SF-36 quality of life questionnaire
2
Description
hives severity
Timepoint
Weekly to Week 9, Week 12 and Week 16
Method of measurement
Urticaria Activity score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with chronic idiopathic urticaria - 5 cc blood is taken from the brachial vein and centrifuged at 2000 rpm 2.5 cc of the patient's serum will be injected deep into the muscle (arm or hips) with needle 22. Injections will be on a weekly basis for up to 9 weeks.
Category
Treatment - Other
2
Description
Control group: Patients with chronic idiopathic urticaria - It was treated with oral antihistamines and will also be injected deep into muscle as placebo 3 cc normal saline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Rasoul Nasiri Kalmarzi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3323 0524
Email
rasool_nsr@yahoo.com
2
Recruitment center
Name of recruitment center
Kurdistan Asthma and Allergy Clinic
Full name of responsible person
Rasoul Nasiri Kalmarzi
Street address
Kurdistan Asthma and Allergy Clinic, Razi building, Vakil intersection, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3323 0524
Fax
+98 87 3323 0524
Email
rasool_nsr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 4645
Email
rasool_nsr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Rasol Nasiri Kalmarzi
Position
Cellular & Molecular Research Center, Kurdistan University of Medical Sciences, Sanandaj, Iran
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Pasdaran street Kurdistan university of medical scions
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3323 0524
Fax
+98 87 3323 0524
Email
rnasiri@Razi.Tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rasol Nasiri Kalmarzi
Position
Cellular & Molecular Research Center, Kurdistan University of Medical Sciences, Sanandaj, Iran
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Pasdaran street Kurdistan university of medical scions
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3323 0524
Fax
+98 87 3323 0524
Email
rnasiri@Razi.Tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Assistant (Researcher Deuty Soldier)
Latest degree
Medical doctor
Other areas of specialty/work
Public Health
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 4645
Email
khalafi.behzad70@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
Rasool Nasiri Kalmarzi - Be'sat Hospital - Kurdistan University of Medical Science
What processes are involved for a request to access data/document
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given.