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IRCT20200909048677N1 IRCT 2020-10-05 Kashan University of Medical Sciences Comparing the effectiveness of combination therapy and monotherapy on quality of life in patients with persistent allergic rhinitis Comparing the effectiveness of desloratadine plus montelukast combination therapy and desloratadine monotherapy on quality of life in patients with persistent allergic rhinitis 2020-05-21 anticipated 56 Complete https://irct.ir/trial/50916 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To randomly assign each sample to intervention and control groups, first create a randomization list using the website www. sealedenvelope.com/simple-randomiser/v1/lists and was prepared by Balanced (permuted) block randomization method. According to the entry turn of each sample to the study and random sequence, the individuals are assigned to one of the two groups A (control group) and B (intervention group), Blinding description: Two types of medication packages, called A and B, were designed by an expert who did not participate in the study. One package contained des loratadine tablets and Montelukast tablets. And the other package included des lortadine tablets and placebo.It should be noted that the placebo was quite similar to Montelukast in shape, color and size. 2-3 allergic rhinitis. Intervention 1: Intervention group: The recipient group is a combination of desloratadine and Montelukast. In this study, 5 mg des loratadine tablets made by Abidi Pharmaceutical Company, 1 tablet every night for 6 weeks of intervention are used. In addition, 10 mg Montelukast tablets made by Abidi Pharmaceutical Company are used, 1 tablet every night for 6 weeks of intervention. During this period, the use of drugs is controlled by telephone. Intervention 2: Control group: group of des loratadine and placebo. In this study, 5 mg des loratadine tablets made by Abidi Pharmaceutical Company, 1 tablet every night for 6 weeks of intervention are used. In addition placebo which is quite similar to Abidi's Montelukast tablet and is made from the same company is used. 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 information
public Shayan Ramezanpour
Kashan University of Medical Sciences, Ghotb-e-Ravandi boulevard
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5546 4950 dr.sh.ramezanpour@gmail.com Kashan University of Medical Sciences scientific Amir Hossenin Ahsani Arani
Matini hospital, Amir kabir street
Kashan Iran (Islamic Republic of) 87196 74591 +98 31 5534 2020 amirhosein.ahsani1397@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with allergic rhinitis who are symptomatic for more than 4 weeks and also more than 4 days a week Existence of persistent allergic rhinitis during the last 2 years Age 18-65 years 18 years 65 years Both unwillingness to cooperate Severe upper respiratory tract disease during the 6 weeks prior to the study Nasal polyps or deviation of the nasal septum Acute or chronic rhinosinusitis smoking Bronchial asthma Pregnancy or breastfeeding Taking antihistamines during the last 1 month Use of systemic or topical corticosteroids History of allergies to Montelukast or Des Loratadine J30 Vasomotor and allergic rhinitis Treatment - Drugs Treatment - Drugs Intervention group: The recipient group is a combination of desloratadine and Montelukast. In this study, 5 mg des loratadine tablets made by Abidi Pharmaceutical Company, 1 tablet every night for 6 weeks of intervention are used. In addition, 10 mg Montelukast tablets made by Abidi Pharmaceutical Company are used, 1 tablet every night for 6 weeks of intervention. During this period, the use of drugs is controlled by telephone. Control group: group of des loratadine and placebo. In this study, 5 mg des loratadine tablets made by Abidi Pharmaceutical Company, 1 tablet every night for 6 weeks of intervention are used. In addition placebo which is quite similar to Abidi's Montelukast tablet and is made from the same company is used. Quality of life score. Timepoint: Once before starting treatment and once 6 weeks after starting treatment. Method of measurement: mini-RQLQ checklist. Runny nose. Timepoint: Once before treatment and once 6 weeks after. Method of measurement: Nasal symptom score checklist. The severity of these symptoms is assessed based on the nasal symptom score. In this questionnaire, the patient scores the 4 main symptoms of allergic rhinitis from 0 (absence of the desired symptom) to 3 (severe). Sneezing. Timepoint: Once before treatment and once 6 weeks after. Method of measurement: Nasal symptom score checklist. The severity of these symptoms is assessed based on the nasal symptom score. In this questionnaire, the patient scores the 4 main symptoms of allergic rhinitis from 0 (absence of the desired symptom) to 3 (severe). Nasal congestion. Timepoint: Once before treatment and once 6 weeks after. Method of measurement: Nasal symptom score checklist. The severity of these symptoms is assessed based on the nasal symptom score. In this questionnaire, the patient scores the 4 main symptoms of allergic rhinitis from 0 (absence of the desired symptom) to 3 (severe). Itching. Timepoint: Once before treatment and once 6 weeks after. Method of measurement: Nasal symptom score checklist. The severity of these symptoms is assessed based on the nasal symptom score. In this questionnaire, the patient scores the 4 main symptoms of allergic rhinitis from 0 (absence of the desired symptom) to 3 (severe). personal Approved 2020-09-01 Ethics Committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Ghotb-e-Ravandi boulevard kashan Isfehan Iran (Islamic Republic of)