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IRCT201202088961N1 IRCT 2013-01-01 Shahid Beheshti University of Medical sciences The efficacy of Nigella sativa on chronic rhinosinusitis The efficacy of Nigella sativa nasal oil drop on chronic rhinosinusitis patients’ quality of life in comparison with placebo. 2012-10-06 anticipated 52 Complete https://irct.ir/trial/9417 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Chronic Rhinosinusitis. Intervention 1: Intervention:Nigella sativa oil in base of sesame oil. Intervention 2: Control:sesame oil.
public Mohammad reza Masroorchehr
Shams Alley, opposite Tavanir, Vali-e-Asr Ave
Tehran Iran (Islamic Republic of) +98 218877352125 m.masroorchehr@sbmu.ac.ir, masroor_shahr@yahoo.com Shahid Beheshti University of Medical sciences,Faculty of Traditional Medicine scientific Mohammad reza Masroorchehr
No 25,Lale St,Fifth Taleghani St,Moallem Ave
Rasht Iran (Islamic Republic of) +98 13 1222 0149 m.masroorchehr@sbmu.ac.ir, masroor_shahr@yahoo.com Shahid Beheshti University of Medical sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria:existence of 2 major signs or one major and 2 minor signs of rhinosinusitis in patients; patients have at least 12 consecutive weeks' duration of rhinosinusitis;patients have proved rhinosinusitis by CT-scan; patients are 16 to 65 years old exclusion criteria: pregnant patient; patients who are taking daily corticosteroid drugs; immunocompromised patients; patients having fever more than 37.8c; existence of any polyp in the nasal cavity Drop out: patient drug intolerancy; patient pregnancy when using drug; fever more than 38.5 c when using drug; patient unwillingness to continue participating in clinical trial 16 years 65 years Both J32.9 Sinusitis (chronic) NOS Treatment - Drugs Placebo Intervention:Nigella sativa oil in base of sesame oil Control:sesame oil SNOT-22 Questionnaire result score. Timepoint: before intervention day(0), and a weak after the end of intervention day(28). Method of measurement: SNOT-22 Questionnaire. Facial pain/pressure. Timepoint: days (0), (28). Method of measurement: yes/ No. Facial congestion/fullness. Timepoint: days (0), (28). Method of measurement: yes/ no. Nasal obstruction/blockage. Timepoint: days (0), (28). Method of measurement: yes/ no. Nasal discharge/purulence, discolored posterior drainage. Timepoint: days (0), (28). Method of measurement: yes/ no. Hyposmia/anosmia. Timepoint: days (0), (28). Method of measurement: yes/ no. Purulence on nasal examination. Timepoint: days (0), (28). Method of measurement: yes/ no. Headache. Timepoint: days (0), (28). Method of measurement: yes/ no. Fever (nonacute rhinosinusitis). Timepoint: days (0), (28). Method of measurement: yes/ no. Halitosis. Timepoint: days (0), (28). Method of measurement: yes/ no. Fatigue. Timepoint: days (0), (28). Method of measurement: yes/ no. Dental pain. Timepoint: days (0), (28). Method of measurement: yes/ no. Cough. Timepoint: days (0), (28). Method of measurement: yes/ no. Ear pain/pressure/fullness. Timepoint: days (0), (28). Method of measurement: yes/ no. Side effects. Timepoint: before intervention and days 1,7,14,21,28. Method of measurement: Questionnaire. Shahid Beheshti University of Medical sciences Approved 2012-01-08 Shahid Beheshti University of Medical sciences next to Ayatollah Taleghani Hospital, Evin, Shahid Chamran Expressway, Tehran Tehran Iran (Islamic Republic of)