Objective: controlled clinical study comparing the effect of autologous serum therapy and placebo in severe chronic urticaria. Inclusion criteria: patients entered the study had severe urticaria for at least 6 weeks in most of the days; not responding to antihistamines; patients who had no other systemic disease; those with negative food allergy skin test; patients without urticaria vasculitis. Exclusion criteria: patients with systemic disease; those who had positive allergy skin test with food; those who had a good response to antihistamines. The study population: patients with severe chronic urticaria. Target sample size: 50 patients. Design: Took 6 ml blood from patients and after clotting put it in Centrifuge to run with 2000 rpm for 10 mines separating serum then inject 2.5 ml serum deeply in Deltoids muscle, in control group 2.5 ml normal saline injected instead as single blind. Intervention: weekly for 9 weeks, then monthly for 3-6 months injection were given. Time project: 2013 – 2014. Primary outcome measure: before onset of treatment and end of weekly treatment and end of monthly treatment. Patients are checked for 6 parameters.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061818137N1
Registration date:2015-01-25, 1393/11/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Reza Amin
Name of organization / entity
Shiraz University of Medical Scince
Country
Iran (Islamic Republic of)
Phone
+98 71 3228 8574
Email address
aminr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-01-30, 1392/11/10
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Controlled clinical trial comparing the efficacy of autologous serum therapy and placebo on severe chronic urticaria
Public title
Assessment of effect of autologus serum therapy on severe chronic urticaria and comparison with placebo injections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients entered the study had severe urticaria for at least 6 weeks in most of the days; not responding to antihistamines؛ patients who had no other systemic disease; those with negative food allergy skin test; patients without urticaria vasculitis.
Exclusion criteria: patients with systemic disease; those who had positive allergy skin test with food; those who had a good response to antihistamines.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
After selecting patients who met the before mentioned criteria and taking their informed consent they filled a questioner including: name, age , sex , local address , tell number, details of symptoms clinically in sampling. Before onset of treatment and end of 9 weekly treatment and end of monthly treatment. Patients are checked for 6 parameters.Took 6 ml blood from patients and after clotting put it in Centrifuge to run with 2000 rpm for 10 min separating serum then inject 2.5 ml serum deeply in Deltoids muscle, in control group 2.5 ml normal saline injected instead as single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2014-01-21, 1392/11/01
Ethics committee reference number
CT-P-9367-6837
Health conditions studied
1
Description of health condition studied
severe chronic urticaria
ICD-10 code
L50.1
ICD-10 code description
Idiopathic urticaria
Primary outcomes
1
Description
Questionnaire
Timepoint
Before onset of treatment and end of weekly treatment and end of monthly treatment
Method of measurement
physical examination and history
Secondary outcomes
empty
Intervention groups
1
Description
The injection of 2.5 ml of autologous serum for 9 weeks and then monthly for 3 to 6 months.
Category
Treatment - Drugs
2
Description
The injection of 2.5 ml of normal saline for 9 weeks and then monthly for 3 to 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Clinic
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Sciences Shiraz
Full name of responsible person
Dr.Postforosh
Street address
Zand street, Shiraz
City
Shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Shiraz
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
Shiraz University of Medical Sciences
Full name of responsible person
Farhad Abolnezhadian
Position
Fellow for Allergy and Clinical Immunology
Other areas of specialty/work
Street address
Division of Immunology, Namazi hospital, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3228 8574
Fax
Email
abolnezhadian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Amin
Position
Allergist and Clinical Immunologist
Other areas of specialty/work
Street address
Division of Immunology, Namazi hospital, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3612 5449
Fax
Email
aminr@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farhad Abolnezhadian
Position
Fellow for Allergy and Clinical Immunology
Other areas of specialty/work
Street address
Fars
City
Shiraz
Postal code
Phone
+98 71 3228 8574
Fax
Email
abolnezhadian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)