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IRCT201703079014N149 IRCT 2017-03-12 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of Nasil drop (sesame based black seeds) versus placebo on treatment of chronic rhinosinusitis Effect of Nasil drop (sesame based black seeds) versus placebo on treatment of chronic rhinosinusitis: a triple blind randomized clinical trial 2017-04-04 anticipated 50 Complete https://irct.ir/trial/9587 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind. 2 chronic rhinosinusitis. Intervention 1: Intervention group: Nasil drop (sesame based black seeds) one drop in the right nostril at the first night, one drop in the left nostril at the second night, two drops in the right nostril at the third night, two drops in the left nostril at the fourth night; three drops in the right nostril at the fifth night and three drops in the left nostril at the sixth night; then, the drop will be quit for one week and again drop will be started the same way once more. Intervention 2: Control group: Placebo drop (including distilled water) one drop in the right nostril at the first night, one drop in the left nostril at the second night, two drops in the right nostril at the third night, two drops in the left nostril at the fourth night; three drops in the right nostril at the fifth night and three drops in the left nostril at the sixth night; then, the drop will be quit for one week and again drop will be started the same way once more.
public Dr Tahereh Mozayyan
Besat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) +98 81 3364 0030 dr_t_mozayyan@yahoo.com Besat Hospital scientific Dr Rooholah Abbasi
Besat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) +98 81 3364 0030 r.abbasi@umsha.ac.ir Besat Hospital Iran (Islamic Republic of) Inclusion criteria: Age of 18 to 64 years; chronic rhinosinusitis. Exclusion criteria: Pregnancy; fever; immunosuppression; nasal polyp; sensitivity to black seeds or sesame. 18 years 64 years Both J32.9 Chronic sinusitis, unspecified Treatment - Drugs Placebo Intervention group: Nasil drop (sesame based black seeds) one drop in the right nostril at the first night, one drop in the left nostril at the second night, two drops in the right nostril at the third night, two drops in the left nostril at the fourth night; three drops in the right nostril at the fifth night and three drops in the left nostril at the sixth night; then, the drop will be quit for one week and again drop will be started the same way once more. Control group: Placebo drop (including distilled water) one drop in the right nostril at the first night, one drop in the left nostril at the second night, two drops in the right nostril at the third night, two drops in the left nostril at the fourth night; three drops in the right nostril at the fifth night and three drops in the left nostril at the sixth night; then, the drop will be quit for one week and again drop will be started the same way once more. Status of rhinosinusitis. Timepoint: before intervention, immediately after intervention and 3 weeks later. Method of measurement: based on Vas score. Status of rhinosinusitis. Timepoint: before intervention, immediately after intervention and 3 weeks later. Method of measurement: based on Snot-22 score. Status of rhinosinusitis. Timepoint: before intervention, immediately after intervention and 3 weeks later. Method of measurement: based on endoscopic. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2016-04-09 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)