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IRCT20161022030439N2 IRCT 2018-01-30 Gorgan University of Medical Sciences The influence of Marjoram oil Extract (Origanum Vulgare) in treatment of chronic rhinosinusitis CRS Comparative evaluation of the influence of Marjoram oil Extract (Origanum Vulgare) in treatment of chronic rhinosinusitis without nasal polyps with fluticasone spray and sesame oil, concomitant with Life style modification of Traditional Persian Medicine, (a randomized, double-blind, clinical trial) 1991-01-21 anticipated 75 Complete https://irct.ir/trial/24181 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Patients will be randomly divided into 3 groups; cases and controls based on Simple Random Allocation (random numbers table), Blinding description: Both the drugs and the placebo are similar in size, shape, color and odor to prevent the bias in participants, clinical care provider and outcome evaluators. And each patient will get an unique code. 3 Chronic sinusitis. Intervention 1: Prescribed in this group are:1- Marjoram oil nasal spray 2 puffs in each nostril Q12h for 4 wk. 2- Decosalin nasal spray 2 puffs Q12h for 4 wk. 3- Life style modification of Traditional Persian Medicine (LTPM). At the beginning, the Origanum Vulgare from the Gorgan Mountains collected its Voucher Number (1613) and dried. In order to prepare the drug, its semi-weighed was mixed with sesame oil and kept in an incubator at 50 ° C for 72 hours, then passed through the filter and marjoram oil was extracted. In each drop of this extract, equivalent 0.017% of carvacrol is vailable. Life style modification of Traditional Persian Medicine contain: 1- avoiding supination and cool weather contact with the forehead and face 2- nasal irritation and sneezing at the first days of treatment 3- intense physical activities 4- reducing consumptions of some vegetables, such as garlic and onions, as well as date palm during an acute illness phase 5- limiting daily sleep 6- reinforcing the brain by inhaling rose, apple and saffron aromas 7- foot massage. Intervention 2: Prescribed in this group are: 1- Fluticasone nasal spray 2 puffs in each nostril Q12h for 4 wk. 2- Decosalin nasal spray 2 puffs Q12h for 4 wk. 3- Life style modification of Traditional Persian Medicine (LTPM). Life style modification of Traditional Persian Medicine contain: 1- avoiding supination and cool weather contact with the forehead and face 2- nasal irritation and sneezing at the first days of treatment 3- intense physical activities 4- reducing consumptions of some vegetables, such as garlic and onions, as well as date palm during an acute illness phase 5- limiting daily sleep 6- reinforcing the brain by inhaling rose, apple and saffron aromas 7- foot massage. Intervention 3: Prescribed in this group are: 1- Sesame oil nasal spray (placebo) 2 puffs in each nostril Q12h for 4 wk. 2- Decosalin nasal spray 2 puffs Q12h for 4 wk. 3- Life style modification of Traditional Persian Medicine (LTPM). Life style modification of Traditional Persian Medicine contain: 1- avoiding supination and cool weather contact with the forehead and face 2- nasal irritation and sneezing at the first days of treatment 3- intense physical activities 4- reducing consumptions of some vegetables, such as garlic and onions, as well as date palm during an acute illness phase 5- limiting daily sleep 6- reinforcing the brain by inhaling rose, apple and saffron aromas 7- foot massage. 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 Undecided - It is not yet known if there will be a plan to make this available
public Seyed Abdolreza Kamaneh
Unit 5, The residential complex of Najafinejad, 6th Farhang, 9th Sayyad, Martyr Sayyad shirazi Boulevard
Gorgan Iran (Islamic Republic of) 4917976136 +98 17 3254 5923 dr.kamaneh@goums.ac.ir Gorgan University of Medical Sciences scientific Marzieh Qaraaty
Unit 1, The residential complex of Rose, 30th Sayyad, Martyr Sayyad shirazi Boulevard
Gorgan Iran (Islamic Republic of) 4917816337 +98 17 3254 3614 gharaaty1387@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1- People with chronic sinusitis approved by the Academy of Otolaryngology-Head and Neck Ligation. This criteria contains the typical symptoms of chronic sinusitis, with or without appropriate medical treatment for more than 12 weeks. 2- Positive CT scan which indicates the opacity and swelling of the sinus mucosa. 3- Patients aged 18 to 60 years. 4- Fill the letter of satisfaction by the patient 18 years 60 years Both Nose and sinus surgery in the last 5 years Antibiotic or topical corticosteroid use 15 days before entering the study Using oral corticosteroid 30 days before entering the study Moderate to severe asthma and mild asthma that has had an acute attack less than 30 days ago Aspirin- Exacerbated Respiratory Disease Active infections in the nose and sinuses Polyps in the nose Other diseases (neurogenic or psychiatric illness, malignancy, immunodeficiency) in the last 5 years, so that according to researcher, does not have the required qualifications to participate in the clinical trial Pregnancy j32.9 Sinusitis (chronic) NOS Treatment - Drugs Treatment - Drugs Placebo Prescribed in this group are:1- Marjoram oil nasal spray 2 puffs in each nostril Q12h for 4 wk. 2- Decosalin nasal spray 2 puffs Q12h for 4 wk. 3- Life style modification of Traditional Persian Medicine (LTPM). At the beginning, the Origanum Vulgare from the Gorgan Mountains collected its Voucher Number (1613) and dried. In order to prepare the drug, its semi-weighed was mixed with sesame oil and kept in an incubator at 50 ° C for 72 hours, then passed through the filter and marjoram oil was extracted. In each drop of this extract, equivalent 0.017% of carvacrol is vailable. Life style modification of Traditional Persian Medicine contain: 1- avoiding supination and cool weather contact with the forehead and face 2- nasal irritation and sneezing at the first days of treatment 3- intense physical activities 4- reducing consumptions of some vegetables, such as garlic and onions, as well as date palm during an acute illness phase 5- limiting daily sleep 6- reinforcing the brain by inhaling rose, apple and saffron aromas 7- foot massage. Prescribed in this group are: 1- Fluticasone nasal spray 2 puffs in each nostril Q12h for 4 wk. 2- Decosalin nasal spray 2 puffs Q12h for 4 wk. 3- Life style modification of Traditional Persian Medicine (LTPM). Life style modification of Traditional Persian Medicine contain: 1- avoiding supination and cool weather contact with the forehead and face 2- nasal irritation and sneezing at the first days of treatment 3- intense physical activities 4- reducing consumptions of some vegetables, such as garlic and onions, as well as date palm during an acute illness phase 5- limiting daily sleep 6- reinforcing the brain by inhaling rose, apple and saffron aromas 7- foot massage. Prescribed in this group are: 1- Sesame oil nasal spray (placebo) 2 puffs in each nostril Q12h for 4 wk. 2- Decosalin nasal spray 2 puffs Q12h for 4 wk. 3- Life style modification of Traditional Persian Medicine (LTPM). Life style modification of Traditional Persian Medicine contain: 1- avoiding supination and cool weather contact with the forehead and face 2- nasal irritation and sneezing at the first days of treatment 3- intense physical activities 4- reducing consumptions of some vegetables, such as garlic and onions, as well as date palm during an acute illness phase 5- limiting daily sleep 6- reinforcing the brain by inhaling rose, apple and saffron aromas 7- foot massage. Cough. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Posterior nasal discharge. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Need to blow nose. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Sneezing. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Runny nose. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Nasal obstruction. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Loss of smell or taste. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Thick nasal discharge. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Post-nasal discharge. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Ear fullness. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Dizziness. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Ear pain. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Facial pain/pressure. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Difficulty falling asleep. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Waking up at night. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Lack of a good night’s sleep. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Waking up tired. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Exhausted feeling during day. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Reduced productivity. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Reduce concentration. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Frustration or irritability. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Sad. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Embarrassed. Timepoint: Before and the end of the intervention. Method of measurement: SNOTE22 questionnaire. Gorgan University of Medical Sciences Approved 2018-01-17 Ethics committee of Golestan Univercity of Medical Sciences Phalsaphy complex, Shast kola Road Gorgan Golestan Iran (Islamic Republic of)