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IRCT20110614006804N2 IRCT 2021-01-15 Bagheiat-allah University of Medical Sciences Budesonide and Rasa Sinex effects on allergic rhinitis Comparison of Budesonide and Rasa Sinex nasal sprays on control of allergic rhinitis patients 2020-12-17 anticipated 100 Complete https://irct.ir/trial/36956 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: none, Randomization description: First, the medicines are prepared in the same packaging and appearance and size. Then they are coded based on codes already prepared using random numbers table. Randomization method: Permuted block randomization is done so that first all blocks of size 4 containing two codes A and B are prepared and then random blocks are selected by placement using random numbers table (25 blocks). These blocks form a sequence of 100 codes A and B, each of which is randomly assigned to one of the groups. The list of codes for each drug will remain with one of the executors until the end of the study. Numerical codes from 1 to 100 are recorded on drugs, and patients receive drug no. 1 to 100 after entering the study, respectively, Blinding description: In this study, first of all, we explain the patients about the random allocation in one of the two routine treatment. Then, according to the simple randomized method, they will put in group A or B. According to this, one of the drugs that are completely similar and only tagged as A, B will be prescribed for him/her. 2-3 Condition 1: Allergy. Condition 2: Allergy. Intervention 1: The first intervention group is consisted of people who receive Rasa sinex spray. This spray is made by Artiman Company, contain olive oil and black seeds extract. The patient should use the drug twice a day every 12 hours in the nose for one month. Intervention 2: The second intervention group is consisted of those who receive Budesonide spray. This spray is manufactured by Cipla India company, named Naxonella, contain 0.5 mg/2 cc of inhaled glucocorticoids. The patient should use the drug twice a day every 12 hours in the nose for one month. Yes - There is a plan to make this available What will be shared: After deleting the patient's identification data; data sharing could be possible. When: Immediately after the result publication. To whom: Only for academic and research requesting Conditions: After researcher's request assessment, it could be possible for sharing the data. Where to obtain: Via the corresponding author of the research. How to obtain: First of all a requesting email should send for the corresponding author;after the confirmation of the sender identity and his/her goal, we could share the data. Comments:
public Mohammad Javad Behzadnia
Emergency department, Baghyatallah Hospital, Nosrati alley, Sheikh Bahaie street, Molla Sadra street, Vanaq square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8126 2012 behzadnia@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Mohammad Javad Behzadnia
Trauma Research Center; Baqiyatallah University of Medical Sciences; Nosrati alley; Sheikh Bahaie street; Molla Sadra street; Vanaq square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8126 2012 behzadnia@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients with allergic rhinitis who are confirmed by the clinical immunologist or Otolaryngologist 18 years no limit Both History of Asthma Acute bacterial sinusitis Recent topical or systemic Corticosteroid treatment Severe polyposis in rhino-endoscopy allergy to the black seeds and olive oil active nasal bleeding acute bronchitis pneumonia upper respiratory tract infection J30.1 J30.2 Allergic rhinitis due to pollen Other seasonal allergic rhinitis Treatment - Drugs Treatment - Drugs The first intervention group is consisted of people who receive Rasa sinex spray. This spray is made by Artiman Company, contain olive oil and black seeds extract. The patient should use the drug twice a day every 12 hours in the nose for one month. The second intervention group is consisted of those who receive Budesonide spray. This spray is manufactured by Cipla India company, named Naxonella, contain 0.5 mg/2 cc of inhaled glucocorticoids. The patient should use the drug twice a day every 12 hours in the nose for one month. Allergic symptoms severity score based on the European Standard Allergy Questionnaire (ECRHS SCREENING QUESTIONNAIRE). Timepoint: day 0 and day30. Method of measurement: we will use the Demographic information and symptom severity questionnaire based on the European Standard Allergy Questionnaire (ECRHS SCREENING QUESTIONNAIRE), a validated sample of which is used in Persian. Bagheiat-allah University of Medical Sciences Approved 2020-12-17 Baqiyatallah hospital Trauma Research Center; Baqiyatallah University of Medical Sciences; Nosrati alley; Sheikh Bahaie street; Molla Sadra street; Vanaq square Tehran Tehran Iran (Islamic Republic of)