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IRCT2014010516083N1 IRCT 2014-08-29 Deputy of Research,Tehran University of Medical Sciences The effect of an anise-based product in Iranian traditional medicine, on the Treatment of patients with chronic rhinosinusitis (CRSsNP) , in comparison to fluticasone nasal sprayMedicine The effect of an anise-based product in Iranian traditional medicine, on the Treatment of patients with chronic rhinosinusitis (CRSsNP) , in comparison to fluticasone nasal spray 2013-09-23 anticipated 74 Complete https://irct.ir/trial/15146 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Chronic sinusitis, unspecified. Intervention 1: Intervention: herbal nasal drop two times daily 3 drop in each nostril plus nasal irrigation for one month. Intervention 2: Control: Fluticasone spray two puff in each nostril Two times daily plus nasal irrigation for one month.
public Shima Vazifehkhah
Vahdat Eslami St. corner of Behesht St.
Tehran Iran (Islamic Republic of) +98 21 5558 0386 sh-vazifehkhah@razi.tums.ac.ir School of Traditional Medicine, Tehran University Of Medical Sciense scientific Dr Babak Saedi
Tehran, Keshavarz Blvd, Imam Khomeini Hospital
Thran Iran (Islamic Republic of) +98 21 6658 1628 saedi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients with presence of chronic rhinosinusitis symptoms for at least 12 weeks; positive CT result indicating the opacity and swelling of the sinus; Patients 18 to 75 years of both sexes; Treatment with systemic or nasal antibiotics or corticosteroids within 4 weeks before visit; Treatment wit h oral corticosteroids within the 30 days before visit; Treatment with topical corticosteroids within 15 days before visit. Exclusion criteria: nasal and sinus surgery within the last 5 years; Presence of moderate to severe co-morbid asthma and mild asthma having exacerbation within 30 days prior to trial inclusion; Rhinitis medicamentosa (drug induced rhinitis); Known hypersensitivity to the medication or excipients; The signs and symptoms of bacterial sinusitis (fever ≥ 38.5, ocular complications, severe unilateral frontal headache or toothache); Acute seasonal allergy; other diseases which in the opinion of the investigator disqualifies the patient for trial enrolment(such as heart failure, kidney, lung and liver, drug addiction or alcoholism, neurological or psychiatric diseases, cancer, immunodeficiency) in the past 5 years; any side effect during treatment; Pregnancy; Breastfeeding 15 years 75 years Both J32.9 Sinusitis (chronic) NOS Treatment - Drugs Treatment - Drugs Intervention: herbal nasal drop two times daily 3 drop in each nostril plus nasal irrigation for one month Control: Fluticasone spray two puff in each nostril Two times daily plus nasal irrigation for one month Recovery. Timepoint: before intervention (day 0), and end of intervention (day 28). Method of measurement: SNOT-22 Questionnaire. Side effects. Timepoint: day 7; day 28. Method of measurement: Ask the patient; The patient stated. Deputy of Research,Tehran University of Medical Sciences Approved 2014-01-27 Vice-chancellor for research Blv Keshavarz, Ghods St., 6th flour Tehran Iran (Islamic Republic of)