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IRCT20150716023235N19 IRCT 2023-12-09 Mashhad University of Medical Sciences Nasal Probiotic Efficacy in Allergic Rhinitis Nasal Probiotic Efficacy in Perennial Allergic Rhinitis Symptom Control and Recurrence 2023-11-22 anticipated 64 Complete https://irct.ir/trial/73634 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the blocking method will be used. In this way, study group A and control group B will be considered. According to the sample size of two groups, 8 random blocks of 4 are used. 1. AABB BBAA 2. BBAA AABB 3. ABAB AABB 4. BABA ABAB The random numbers table (https://www.Randomization.com) will be used to place the samples in the blocks randomly, Blinding description: The sprays prepared in the intervention and control groups are completely similar in terms of shape, appearance, and smell. Allocation of people in two groups will be done randomly. The groups will be entered into SPSS software as A and B, and the analyst will not know about the intervention and control groups. In two follow-ups, one and three months, it will be done by a doctor who does not know about the division of patients into intervention and control groups. 2-3 Allergic Rhinitis. Intervention 1: Intervention group: (Probiotic group) - In the first month, participants will use Mometasone nasal spray with probiotic nasal spray twice daily. In the second and third months, they will take only probiotic nasal spray twice daily. Intervention 2: Control group: control group – Participants will take intranasal Mometasone twice daily for three months. In the first month, also use a placebo nasal spray twice a day. Yes - There is a plan to make this available What will be shared: Not applicable When: Not applicable To whom: Not applicable Conditions: Not applicable Where to obtain: Not applicable How to obtain: Not applicable Comments:
public Rana Tafrishi
Ahmad abad AVE, Ghaem hospital
Mashhad Iran (Islamic Republic of) 991991766 +98 51 3801 2298 ranatafrishi96@gmail.com Mashhad University of Medical Sciences scientific Farahzad Jabbari Azad
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad Mashhad
Mashhad Iran (Islamic Republic of) 9119-91766 +98 51 3801 2298 jabbarif@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients with chronic allergic rhinitis who have clinical symptoms consistent with allergic rhinitis and a positive skin test with aeroallergens Age above 8 years and less than 50 years Patient satisfaction 8 years 50 years Both Taking antibiotics while taking probiotics Consumption of compounds containing probiotics other than the medicine prescribed in the study Suspected drug allergy symptoms The patient's non-cooperation in regular drug use and tests Pregnancy Taking immunosuppressive drugs Malnutrition Having a history of autoimmune disease or cystic fibrosis Active sinus infection, sinus pain, increased thick nasal secretions J30.1 Allergic rhinitis due to pollen Treatment - Drugs Treatment - Drugs Intervention group: (Probiotic group) - In the first month, participants will use Mometasone nasal spray with probiotic nasal spray twice daily. In the second and third months, they will take only probiotic nasal spray twice daily. Control group: control group – Participants will take intranasal Mometasone twice daily for three months. In the first month, also use a placebo nasal spray twice a day. Nasal smear eosinophils. Timepoint: Before intervention, after 1 and 3 months of intervention. Method of measurement: Microscopical observation. Clinical symptoms. Timepoint: Before intervention, after 1 and 3 months of intervention. Method of measurement: SNOT22 Questionnaire. Quality of Life. Timepoint: Before intervention, after 1 and 3 months of intervention. Method of measurement: miniRQLQ Questionnaire. Mashhad University of Medical Sciences Approved 2023-08-14 Ethics Committee in Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)