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IRCT20181216042006N1 IRCT 2020-12-07 Birjand University of Medical Sciences Comparison of the efficacy of domestic allergenic extracts with matched commercial imported extracts A multi-centers Non-inferiority clinical trials for evaluating the efficacy of inhalant and food allergic extracts made from domestic sources by skin prick testing in comparison of their matched commercial extracts on a group of patients with history of allergic diseases visiting allergy clinics 2020-12-21 anticipated 107 Complete https://irct.ir/trial/52308 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic. 2 Condition 1: Allergic rhinitis. Condition 2: Asthma. Condition 3: Atopic dermatitis. Condition 4: Food allergy. Intervention 1: Intervention group: allergic patients who are referred to allergy clinic and are candidate of skin prick test with commercial extracts from Stallergen or Greer Companies. Based on the patient's history and symptoms, skin prick test usually performs with a battery of 20 -30 allergenic extracts from plants' pollen, foods or animals. one drop of each allergenic extracts placed on volar surface of patient's hand and after a small scratch with sterile lancet, the area of wheal and flare recorded after 15 minutes. Intervention 2: Intervention group: allergic patients who are referred to allergy clinic and are candidate of skin prick test and the prick test performed with commercial extracts from Stallergen or Greer Companies, will be tested with domestic extracts on their other hand and after finishing testing with commercial extracts. Based on the patient's history and symptoms, skin prick test usually performs with a battery of 20 -30 allergenic extracts from plants' pollen, foods or animals. one drop of each allergenic extracts placed on volar surface of patient's hand and after a small scratch with sterile lancet, the area of wheal and flare recorded after 15 minutes. After doing skin prick test with commercial extracts and receiving consent form from patients, skin prick test with some of the match domestic extracts will performed on the patient's other hand and the result will be recorded. Domestic extracts were prepared from pollen of some common allergenic plants in Iran as well as food allergens. In case of pollen's extracts, during pollination season, the pollens were collected and with using specific sieves and sedimentation methods, pure pollen achieved and the purity was approved by microscopic evaluation. after that, 1 gram of pure pollen was mixed with 9 milliliters of aqueous buffer for 24 hours and after centrifugation and filtering, total amount of protein in the extracts was measured. In the next step and to evaluate the pattern of allergenic bands in the extracts, SDS-PAGE was performed and finally the sterilization process was done and microbial cultured approved the sterility of the extracts. For stability testing, the extracts were stored either at 37 centigrade degree for 2 months or at 25 centigrade degree for 6 months and after that the quantity and quality of extracts were measured. In case of good stability and sterility the extracts were mixed with equal amount of sterile glycerol and after packaging and labeling will be used for skin prick testing. The result of skin sensitivity and side effects with both commercial and domestic extracts were compared by using proper statistical tests. 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 There is no more data
public Mohammad Fereidouni
Ghaffari street
Birjand Iran (Islamic Republic of) 9717686735 009856323381500 dr.m.fereidouni@gmail.com Birjand University of Medical Sciences scientific Mohammad Fereidouni
Ghaffari street, Birjand Univeristy of Medical Sciences, Birjand, Iran
Birjand Iran (Islamic Republic of) 9717686735 +98 56 3243 3004 dr.m.fereidouni@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) patients with history of allergy to inhalant or food allergens who visit allergy clinics and are candidate of performing skin prick test by specialist 2 years 60 years Both Having serious health problems such as cancer, immunodeficiency, autoimmunity, cardiac disease and severe infection Pregnancy or breastfeeding History of anaphylaxis or uncontrolled asthma Current dermatographism or urticaria History of allergy immunotherapy during the last 5 years Using medicine which interfere with skin prick test such as antihistamines, oral corticosteroids, narcotics or sedatives during the last week J30.1 J45 L20 Z91.01 Allergic rhinitis due to pollen Asthma Atopic dermatitis Food allergy status Diagnosis Diagnosis Intervention group: allergic patients who are referred to allergy clinic and are candidate of skin prick test with commercial extracts from Stallergen or Greer Companies. Based on the patient's history and symptoms, skin prick test usually performs with a battery of 20 -30 allergenic extracts from plants' pollen, foods or animals. one drop of each allergenic extracts placed on volar surface of patient's hand and after a small scratch with sterile lancet, the area of wheal and flare recorded after 15 minutes. Intervention group: allergic patients who are referred to allergy clinic and are candidate of skin prick test and the prick test performed with commercial extracts from Stallergen or Greer Companies, will be tested with domestic extracts on their other hand and after finishing testing with commercial extracts. Based on the patient's history and symptoms, skin prick test usually performs with a battery of 20 -30 allergenic extracts from plants' pollen, foods or animals. one drop of each allergenic extracts placed on volar surface of patient's hand and after a small scratch with sterile lancet, the area of wheal and flare recorded after 15 minutes. After doing skin prick test with commercial extracts and receiving consent form from patients, skin prick test with some of the match domestic extracts will performed on the patient's other hand and the result will be recorded. Domestic extracts were prepared from pollen of some common allergenic plants in Iran as well as food allergens. In case of pollen's extracts, during pollination season, the pollens were collected and with using specific sieves and sedimentation methods, pure pollen achieved and the purity was approved by microscopic evaluation. after that, 1 gram of pure pollen was mixed with 9 milliliters of aqueous buffer for 24 hours and after centrifugation and filtering, total amount of protein in the extracts was measured. In the next step and to evaluate the pattern of allergenic bands in the extracts, SDS-PAGE was performed and finally the sterilization process was done and microbial cultured approved the sterility of the extracts. For stability testing, the extracts were stored either at 37 centigrade degree for 2 months or at 25 centigrade degree for 6 months and after that the quantity and quality of extracts were measured. In case of good stability and sterility the extracts were mixed with equal amount of sterile glycerol and after packaging and labeling will be used for skin prick testing. The result of skin sensitivity and side effects with both commercial and domestic extracts were compared by using proper statistical tests. Positive skin reactivity to domestic extracts in comparison to commercial extracts. Timepoint: 15 minutes after doing skin prick test. Method of measurement: Area of wheal created by extracts in square milometers. Side effects of skin prick testing with commercial or domestic extracts including large local reactions or systemic reactions. Timepoint: during the first 24 hours after doing skin prick test. Method of measurement: A design questionnaire. Birjand University of Medical Sciences Approved 2020-03-03 Ethics committee of Birjand University of Medical Sciences Ghaffari street Birjand South Khorasan Iran (Islamic Republic of)