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Study aim
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Determination of the influence of Marjoram oil Extract (Origanum Vulgare) in treatment of chronic rhinosinusitis without nasal polyps compare with fluticasone spray and placebo, concomitant with Life style modification of Traditional Persian Medicine. Determination and comparison of mean scores of patients' symptoms (according to SNOT22 questionnaire) in marjoram group with fluticasone group before and after treatment. Determine and comparison the CT scan of patients (according to Lund Makey scale) in the Marjoram group with fluticasone before and after treatment. Determination and comparison of mean scores of patients' symptoms (according to SNOT22 questionnaire) in Marjoram group with placebo group before and after treatment. Determine and comparison the possible side effects of Marjoram and fluticason group. Determination of the frequency of major and minor symptoms in chronic rhinosinusitis in 3 groups after receiving the drug.
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Design
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In this research, 75 eligible patients referring to 5 Azar Hospital in Gorgan were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into 2 intervention and 1 control groups.
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Settings and conduct
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Patients who will be referred to "5 Azar Hospital in Gorgan" with diagnosis of chronic rhinosinusitis without polyp will be studied. This study is Randomized double-blind placebo-controlled clinical trial. Participants, clinical care provider, Investigator, outcome assessor, and data analyzers are also blinded in this research.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1- People with chronic sinusitis approved. 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.
No entry criteria:
1- Nose and sinus surgery in the last 5 years.
2- Antibiotic or topical corticosteroid use 15 days before entering the study.
3- Using oral corticosteroid 30 days before entering the study.
4- Moderate to severe asthma and mild asthma that has had an acute attack less than 30 days ago.
5- Aspirin- Exacerbated Respiratory Disease.
6- Active infections in the nose and sinuses.
7- Polyps in the nose.
8- 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.
9- Pregnancy.
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Intervention groups
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ّFirst group: recipient of Marjoram nasal spray, Decosalin nasal spray and Life style modification of Traditional Persian Medicine for 4 wk.
Second group: recipient of Fluticasone nasal spray, Decosalin nasal spray and Life style modification of Traditional Persian Medicine for 4 wk.
Third group: recipient of Sesame nasal spray, Decosalin nasal spray and Life style modification of Traditional Persian Medicine for 4 wk.
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Main outcome variables
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Comparison the scores of SNOT22 questionnaires before and after treatment in all three groups.
Comparison the CT-scan scores before and after treatment in all three groups.
Comparison the major and minor sinusitis symptoms in all three groups.