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IRCT20191014045107N1 IRCT 2019-12-09 Iran University of Medical Sciences Efficacy of Verapamil in patients with chronic rhinosinositis with nasal polyposis CRSwNP Efficacy of Verapamil in patients with chronic rhinosinositis with nasal polyposis reffered to Hazrat Rasool hospital: Double blind placebo control trial 2019-10-23 anticipated 36 Complete https://irct.ir/trial/43031 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: Randomization is based on ZIP code and Random allocation software, Blinding description: Patients randomly are divided two equal double blind groups that receiving verapamil, INS, irrigation or irrigation, INS, Placebo .This study is randomized double placebo control trial and the third person gives Drug and Placebo to patients equally. 2-3 Chronic Rhinosinusitis With polyoposis, Verapamil. Intervention 1: Intervention group: Receiving Verapamil Patients randomly are divided in 18 equal double - blind placebo control in 2 groups . Group 1 receive Verapamil plus Intranasal mometasone plus Nasal irrigation and Group 2 receive Placebo plus Intranasal mometasone plus Nasal irrigation. Minimum dose Verapamil use based on safety dose in Cluster headache that is defined Tab Verapamil 80 mg TDS . This study will do for 3 months. Placebo has the same characteristic of Tab Verapamil (Size, Color, Teste). Drug and Placebo are produced in Alborz daroo pharmaceutical company. FDA approved Intranasal corticosteroid is mometasone. Randomization is based on ZIP code and Random allocation software. Intervention 2: control group: Receiving Placebo Patients randomly are divided in 18 equal double - blind placebo control in 2 groups . Group 1 receive Verapamil plus Intranasal mometasone plus Nasal irrigation and Group 2 receive Placebo plus Intranasal mometasone plus Nasal irrigation. Minimum dose Verapamil use based on safety dose in Cluster headache that is defined Tab Verapamil 80 mg TDS . This study will do for 3 months. Placebo has the same characteristic of Tab Verapamil (Size, Color, Teste). Drug and Placebo are produced in Alborz daroo pharmaceutical company. FDA approved Intranasal corticosteroid is mometasone. Randomization is based on ZIP code and Random allocation software.number and Random allocation software. Yes - There is a plan to make this available What will be shared: All data is acceptable after unidentifying people. When: Beginning period of acceptance is 6 months after printing of results. To whom: Data is acceptable only researchers who are working in academic and scientific centers Conditions: Use of data is allowed for research applications. Where to obtain: Receiving of documents will done by E-mail address. How to obtain: Receiving of documents will done by E-mail address in one month. Comments:
public Mohammad Nabavi
Hazrat e Rasool hospital, Niayesh Ave., Sattarkhan Ave., Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4933 mnabavi44@yahoo.com Iran University of Medical Sciences scientific Afshin Rezaeifar
Hazrat e Rasool hospital, Niayesh Ave., Sattarkhan Ave., Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4933 afshinrezaeifar@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients of Male And Female reffered to Allergy and Clinical Immunology Department of Hazrat e Rasool Center Age between 18-55 years old Diagnosed with Chronic Rhinosinusitis with Nasal Polyps according to the EPOS 2012 consensus criteria; Moderate to Severe (Baseline SNOT-22 Score ≥20) 18 years 55 years Both Patients with the following comorbidities: GI Hypomotility, Heart Failure, Liver Failure, Kidney Disease, Muscular Dystrophy, Pregnant or Nursing Females, Hypertrophic Cardiomyopathy, Atrial and ventricular arrhythmia Patients with conductive heart disease like block grade 2 or 3 in EKG Patients taking the following medications; Aspirin, Beta-blockers, Cimetidine, Clarithromycin, Erythromycin, Cyclosporin, Digoxin, Disopyramide, Diuretics, Flecainide, HIV Protease Inhibitors(Indinavir, Nelfinavir, Ritonavir), Quinidine, Lithium, Pioglitazone, Rifampin and systemic corticosteroids one month before trial HR<60 or SBP<110 or DBP<70 Treatment - Drugs Placebo Intervention group: Receiving Verapamil Patients randomly are divided in 18 equal double - blind placebo control in 2 groups . Group 1 receive Verapamil plus Intranasal mometasone plus Nasal irrigation and Group 2 receive Placebo plus Intranasal mometasone plus Nasal irrigation. Minimum dose Verapamil use based on safety dose in Cluster headache that is defined Tab Verapamil 80 mg TDS . This study will do for 3 months. Placebo has the same characteristic of Tab Verapamil (Size, Color, Teste). Drug and Placebo are produced in Alborz daroo pharmaceutical company. FDA approved Intranasal corticosteroid is mometasone. Randomization is based on ZIP code and Random allocation software. control group: Receiving Placebo Patients randomly are divided in 18 equal double - blind placebo control in 2 groups . Group 1 receive Verapamil plus Intranasal mometasone plus Nasal irrigation and Group 2 receive Placebo plus Intranasal mometasone plus Nasal irrigation. Minimum dose Verapamil use based on safety dose in Cluster headache that is defined Tab Verapamil 80 mg TDS . This study will do for 3 months. Placebo has the same characteristic of Tab Verapamil (Size, Color, Teste). Drug and Placebo are produced in Alborz daroo pharmaceutical company. FDA approved Intranasal corticosteroid is mometasone. Randomization is based on ZIP code and Random allocation software.number and Random allocation software. Efficacy of Verapamil in treatment of patients with CRSwNP based on SNOT-22 questionnaire score. Timepoint: SNOT-22 questionnaire completion in beginning and after 12 weeks of study. Method of measurement: SNOT-22 questionnaire validated in Farsi. Efficacy of Verapamil in treatment of CRSwNP based on Lund - Mc Key score in sinonasal computer tomography scan. Timepoint: Measurement of LMS score in beginning and after 12 weeks of study. Method of measurement: Lund - Mc Key score in sinonasal computer tomography scan by 2 unrelated specialist. Iran University of Medical Sciences Approved 2019-10-09 Ethics committee of IRAN University of Medical Sciences Hazrat E Rasool Hospital, Niayesh Ave., Sattarkhan Ave., Tehran Tehran Tehran Iran (Islamic Republic of)