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IRCT20180113038328N1 IRCT 2018-02-17 Mashhad University of Medical Sciences The effect of Autologous Serum Therapy in Chronic Spontaneous Urticaria The Effect of Autologous Serum Therapy on Chronic Spontaneous Urticaria; Clinical Symptoms and Immunologic Changes 2014-09-23 anticipated 60 Complete https://irct.ir/trial/29010 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Chronic spontaneous urticaria. Intervention group1: Treatment with autologous serum therapy in chronic autoimmune urticaria( group 1) was performed weekly for 10 weeks. At each visit, 5 cc of venous blood was taken in sterile size 10 Falcon tubes, without EDTA anticoagulant. Blood samples were then kept at room temperature for 30 minutes to complete the blood coagulation. The serum was then isolated by centrifuging at 2000 rpm for 10 minutes. Immediately after the conclusion of isolation deep intramuscular injection of 2 cc of the centrifuged serum was performed in sterile conditions in buttock or arm area. To evaluate the effect of autologous serum therapy on clinical improvement of patients, urticaria total severity score and dermatology quality of life index questionnaire were used before treatment (week 0), at the end of treatment (week 10) and one month after treatment (week 14).Before starting and immediately after the completion of autologous serum therapy (weeks 0 and 10), 5 cc of venous blood from 20 randomly selected patients in chronic autoimmune urticaria( group1) was extracted for immunological examination. Then the expression of IL-17, IL-10, IL-4, FOXP3and INF-γ genes was evaluated by Real -time PCR.Intervention group2:Treatment with autologous serum therapy in chronic idiopathic urticaria( group 2) was performed weekly for 10 weeks. At each visit, 5 cc of venous blood was taken in sterile size 10 Falcon tubes, without EDTA anticoagulant. Blood samples were then kept at room temperature for 30 minutes to complete the blood coagulation. The serum was then isolated by centrifuging at 2000 rpm for 10 minutes. Immediately after the conclusion of isolation deep intramuscular injection of 2 cc of the centrifuged serum was performed in sterile conditions in buttock or arm area. To evaluate the effect of autologous serum therapy on clinical improvement of patients, urticaria total severity score and dermatology quality of life index questionnaire were used before treatment (week 0), at the end of treatment (week 10) and one month after treatment (week 14).Before starting and immediately after the completion of autologous serum therapy (weeks 0 and 10), 5 cc of venous blood from 20 randomly selected patients in chronic idiopathic urticaria( group2) was extracted for immunological examination. Then the expression of IL-17, IL-10, IL-4, FOXP3and INF-γ genes was evaluated by Real -time PCR.. Yes - There is a plan to make this available What will be shared: Total non-identifiable data, the potential of the people sharing When: Immediately after the publication of results To whom: For all researchers Conditions: Therapeutic and research use Where to obtain: Majid jafari By email jafari.md.ped@gmail.com How to obtain: Immediately after the email Comments: I have no comment
public Majid jafari
Ahmadabad Blvd,Ghaem Hospital,mashhad Town
Mashhad Iran (Islamic Republic of) 99191-91778 +98 51 3801 2770 jafari.md.ped@gmail.com Mashhad University of Medical Sciences scientific Majid jafari
Ahmadabad Blvd,Ghaem Hospital,mashhad Town
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3801 2770 jafari.md.ped@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Symptoms lasting more than 6 weeks Negative Prick test for oral and inhalatory allergens Aged higher than 15 years Normal laboratory result for CBC/diff - S/E - U/A-LFT-HBsAg-BUN-Cr-ESR-CRP-CH50-ANA-IgE and anti-Helicobacter pylori tests 15 years no limit Both Physical urticaria Allergic and drug urticaria Vasculitis urticaria Cortisone and immunosuppressive use over the past 6 weeks (other than antihistamines) Pregnancy Lactation Other systemic diseases. L50.8 Other urticaria Treatment - Other Intervention group1: Treatment with autologous serum therapy in chronic autoimmune urticaria( group 1) was performed weekly for 10 weeks. At each visit, 5 cc of venous blood was taken in sterile size 10 Falcon tubes, without EDTA anticoagulant. Blood samples were then kept at room temperature for 30 minutes to complete the blood coagulation. The serum was then isolated by centrifuging at 2000 rpm for 10 minutes. Immediately after the conclusion of isolation deep intramuscular injection of 2 cc of the centrifuged serum was performed in sterile conditions in buttock or arm area. To evaluate the effect of autologous serum therapy on clinical improvement of patients, urticaria total severity score and dermatology quality of life index questionnaire were used before treatment (week 0), at the end of treatment (week 10) and one month after treatment (week 14).Before starting and immediately after the completion of autologous serum therapy (weeks 0 and 10), 5 cc of venous blood from 20 randomly selected patients in chronic autoimmune urticaria( group1) was extracted for immunological examination. Then the expression of IL-17, IL-10, IL-4, FOXP3and INF-γ genes was evaluated by Real -time PCR.Intervention group2:Treatment with autologous serum therapy in chronic idiopathic urticaria( group 2) was performed weekly for 10 weeks. At each visit, 5 cc of venous blood was taken in sterile size 10 Falcon tubes, without EDTA anticoagulant. Blood samples were then kept at room temperature for 30 minutes to complete the blood coagulation. The serum was then isolated by centrifuging at 2000 rpm for 10 minutes. Immediately after the conclusion of isolation deep intramuscular injection of 2 cc of the centrifuged serum was performed in sterile conditions in buttock or arm area. To evaluate the effect of autologous serum therapy on clinical improvement of patients, urticaria total severity score and dermatology quality of life index questionnaire were used before treatment (week 0), at the end of treatment (week 10) and one month after treatment (week 14).Before starting and immediately after the completion of autologous serum therapy (weeks 0 and 10), 5 cc of venous blood from 20 randomly selected patients in chronic idiopathic urticaria( group2) was extracted for immunological examination. Then the expression of IL-17, IL-10, IL-4, FOXP3and INF-γ genes was evaluated by Real -time PCR. Spontaneous chronic urticaria is a qualitative variable with clinical parameters and cytokines is a of quantity Variable that is measured with PCR. Timepoint: Before and after treatment, as well as 4 weeks after the completion of treatment. Method of measurement: Urticaria total severity score (TSS) ,dermatology quality of life index (DLQI),Real-time-PCR. Mashhad University of Medical Sciences Approved 2013-09-11 Ethics Committee of Mashhad University of Medical Sciences Knowledge and Health city, In the end of shahid Fakouri Blvd.mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)