]>
IRCT20121031011341N13 IRCT 2024-06-08 Shiraz University of Medical Sciences Evaluation the effect of nasal spray based on herbal extracts on the treatment of chronic rhinosinusitis. Evaluation the effect of nasal spray based on herbal extracts (a traditional Persian medicine formulation) on the treatment of chronic rhinosinusitis, A multicentral randomized double blind placebo-controlled clinical trial 2024-06-21 anticipated 80 Complete https://irct.ir/trial/76400 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample is determined by random block method with 4 blocks and using random numbers table. The block and allocation sequence for concealment will be carried out by the non - involved person in the study. the allocation ratio of the samples is one to one, and the drugs are based on the blocks and the allocation sequence will be assigned to the patients. A third person, other than the main researcher and patient, from the medical staff, enters the patients in sample study group as he does not know the details of the study, Blinding description: it is a double blind study .after completion of consent form and initial knowledge of the research plan , patients will participate in the study , but considering that the drugs are in the same shape , they do not know which group they are in and are unaware of the details .the researcher is unaware of the details of the study and how individuals are assigned to the treatment and the control group . 2-3 Chronic rhinosinusitis. Intervention 1: Intervention group: patients were treated for 3 weeks by nasal spray based on traditional persian medicine 2puff on each nostril for each 8 hours. Intervention 2: Control group: patients use placebo nasal spray which is similar in taste and odor with intervention group for 3 weeks by using 2 puffs in each nostril every 8 hours. 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 No more data is available
public Mohammad Hashem Hashempur
Zand avenue
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸۱۴۳۳۶ +98 71 3230 5410 hashempur@gmail.com Shiraz University of Medical Sciences scientific Mohammad Hashem Hashempur
Zand avenue
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸۱۴۳۳۶ +98 71 3230 5410 hashempur@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with chronic rhinosinusitis without nasal polyposis Lund- Mckay score more than 3 in PNS CT Scan Full consciousness and sign a written consent for participation in the study 18 years 80 years Both Patients with history of previous sinus surgery Pregnant patients or breastfeeding mothers Patients with Samter triad (asthma, allergy to aspirin, nasal polyposis) People who refuse to be involved in this research study J31.0 Chronic rhinitis Treatment - Drugs Placebo Intervention group: patients were treated for 3 weeks by nasal spray based on traditional persian medicine 2puff on each nostril for each 8 hours. Control group: patients use placebo nasal spray which is similar in taste and odor with intervention group for 3 weeks by using 2 puffs in each nostril every 8 hours. Sign & symptom of disease. Timepoint: 3 weeks after intervention. Method of measurement: SNOT 22 questionnaire. Quality of life of patients. Timepoint: 3 weeks after intervention. Method of measurement: RhinoQOL questionnaire. Shiraz University of Medical Sciences Approved 2024-01-14 Ethics Committee of Shiraz University of Medical Science Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences, Zand street, Shiraz, Iran. Shiraz Fars Iran (Islamic Republic of)