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IRCT20181002041210N1 IRCT 2018-10-18 Iran University of Medical Sciences Evaluation of desensitization in patients with sesame anaphylaxis Evaluation of sesame oral immunotherapy effect for desensitization in patients with sesame anaphylaxis 2018-09-23 anticipated 10 Complete https://irct.ir/trial/34219 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 sesame anaphylaxis. Intervention group:at first all patients receive two doses of omalizumaboral (anti IgE antibody)150 mg by subcutaneous injection 4 weeks before starting treatment and second dose at the begining of the immunotherapy.Immunotherapy in two phases:induction phase in 4weeks with weekly incremental increase of sesame tahini(OGHAB HALVA company) according to protocol until reaching to target dose of 5 gram of sesame protein in Rasool hospital allergy clinic & continued daily cosumption of target dose at home for 4 months in maintenance phase.during the study daily telephone followup calls for patients will be done.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After finishing study and publication of the paper,about publication of data will be decided.
public Fereshteh Salari
clinic of Allergy,Hazrat Rasool Akram Hospital,Niayesh Ave,Satarkhan Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2383 drfereshtehsalari@gmail.com Iran University of Medical Sciences scientific Fereshteh Salari
Allergy clinic,Hazrat Rasool Hospital,niayesh Ave,Sattarkhan Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2383 drfereshtehsalari@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) positive oral food challenge with consumption of sesame tahini(OGHAB HALVA company) in patient with sesame anaphylaxis history with or without positive skin prick,skin prick to prick or specific IgE sesame tests 4 years no limit Both age less than 4 years history of cardiovascular disease beta blocker or ACEI drug usage severe or uncontrolled asthma infectious or immune deficiency disease unwillingness of patient T78 Anaphylactic shock due to adverse food reaction Treatment - Other Intervention group:at first all patients receive two doses of omalizumaboral (anti IgE antibody)150 mg by subcutaneous injection 4 weeks before starting treatment and second dose at the begining of the immunotherapy.Immunotherapy in two phases:induction phase in 4weeks with weekly incremental increase of sesame tahini(OGHAB HALVA company) according to protocol until reaching to target dose of 5 gram of sesame protein in Rasool hospital allergy clinic & continued daily cosumption of target dose at home for 4 months in maintenance phase.during the study daily telephone followup calls for patients will be done. Sesame anaphylaxis in oral food challenge. Timepoint: ٍEvaluation of sesame anaphylaxis in the begining of the study(before intervention) and 4 months after the end of immunotherapy. Method of measurement: oral food challenge test. Serum specific sesame immunoglobulin E level. Timepoint: in the begining of the study(before intervention) and 4 months after the end of immunotherapy. Method of measurement: ImmunoCAP specific IgE test. Size of wheal in skin prick test. Timepoint: in the begining of the study(before intervention) and 4 months after the end of immunotherapy. Method of measurement: ruler. Size of wheal in skin prick to prick test. Timepoint: in the begining of the study(before intervention) and 4 months after the end of immunotherapy. Method of measurement: ruler. Iran University of Medical Sciences Approved 2018-03-07 ٍEthics committee of Iran University of Medical Sciences Iran University of Medical Sciences,Near the Milad Tower,Hemmat Highway,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)