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IRCT2014061818137N1 IRCT 2015-01-25 University of Medical Sciences Shiraz Assessment of effect of autologus serum therapy on severe chronic urticaria and comparison with placebo injections Controlled clinical trial comparing the efficacy of autologous serum therapy and placebo on severe chronic urticaria 2014-01-30 anticipated 50 Complete https://irct.ir/trial/16541 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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. 2-3 severe chronic urticaria. Intervention 1: The injection of 2.5 ml of autologous serum for 9 weeks and then monthly for 3 to 6 months. Intervention 2: The injection of 2.5 ml of normal saline for 9 weeks and then monthly for 3 to 6 months.
public Farhad Abolnezhadian
Division of Immunology, Namazi hospital, Shiraz
Shiraz Iran (Islamic Republic of) +98 71 3228 8574 abolnezhadian@yahoo.com Shiraz University of Medical Sciences scientific Reza Amin
Division of Immunology, Namazi hospital, Shiraz
Shiraz Iran (Islamic Republic of) +98 71 3612 5449 aminr@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients entered the study had severe urticaria for at least 6 weeks in most of the days; not responding to antihistaminesØ› 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. no limit no limit Both L50.1 Idiopathic urticaria Treatment - Drugs Placebo The injection of 2.5 ml of autologous serum for 9 weeks and then monthly for 3 to 6 months. The injection of 2.5 ml of normal saline for 9 weeks and then monthly for 3 to 6 months Questionnaire. Timepoint: Before onset of treatment and end of weekly treatment and end of monthly treatment. Method of measurement: physical examination and history. University of Medical Sciences Shiraz Approved 2014-01-21 Ethics committee of Shiraz University of Medical Sciences Zand street, Shiraz Shiraz Iran (Islamic Republic of)