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IRCT20210421051030N1 IRCT 2021-08-13 Alborz University of Medical Science Evaluation of the effects of solution made with flax seed oil in the treatment of rhinosinusitis Evaluation of the effects of topical application of micro emulsion prepared with Flax seed oil carrier of lipophilic active ingredients in the treatment of inflammatory disorders of rhino sinus cavity 2021-08-14 anticipated 99 Complete https://irct.ir/trial/56524 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Other design features: Since the present study includes confounding variables including age, sex and anatomical anomalies, Covariate Adaptive Randomization (CAR) sampling method will be used to distribute and randomly assign patients with different confounders to intervention and control groups. In this method, after placing the first, second and third samples in each of the groups, the researcher places the next samples in the study groups based on the designed table, including three columns of confounder type factor and three rows of control and intervention groups. also adaptive (distribution) means distribution based on the type and number of distorters, which is done with the help of the above method, Blinding description: the researcher In order to blind the research for the patients and the treating physician, has prepared both samples of the drug and placebo in the same form so that they are not aware of the type of drug and placebo treatment. Sprays containing flaxseed oil micro emulsion and spray containing normal isotonic saline (placebo) in similar pumped bottles were marked with A and B marks, respectively. Also, oral antibiotic-antihistamine tablets and placebo tablets with A and B marks were placed in similar cans, respectively. The project clinical assistant then delivers the sprays and tablets, pre-marked A and B, based on the group that the patient has been categorized by sampling method. Also, the collected data with the same abbreviations A and B are delivered to the analyzer to be realized in the third strain of blinding. 2-3 Condition 1: Rhinitis. Condition 2: Sinusitis. Intervention 1: Control group: Patients are treated with oral tablets (single dose of co amoxiclav 325 mg per day in bacterial rhinosinusitis and fexofenadine 180 in allergic rhinosinusitis). They also receive a solution containing normal saline isotonic as a placebo. Intervention 2: Intervention group 1: Patients are treated with a topical solution containing a micro emulsion prepared with flaxseed oil plus an oral tablet (single dose of co amoxiclav 325 mg in bacterial rhinosinusitis and fexofenadine 180 in allergic rhinosinusitis). Intervention 3: Intervention group 2: Patients are treated with a topical solution containing flax seed oil micro emulsion and placebo oral tablets. 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 There is no more information
public Behnam Mokri Savojbolaghi
Shahrake Gharbِ, District 2
Tehran Iran (Islamic Republic of) 1111111111 +98 21 0000 0000 bms1909@iran.ir Iran University of Medical Sciences scientific Behnam Mokri Savojbolaghi
Shahrake Gharb, ِDistrict 2
Tehran Iran (Islamic Republic of) 1111111111 +98 21 0000 0000 bms1909@iran.ir Iran University of Medical Sciences Iran (Islamic Republic of) All Rhinosinusitis patients over 15 years of age and under 60 years of age Not used immunosuppressive and antibiotics drugs during the last week Not allergic to herbal medicines and topical products No systemic diseases involving the Nasal cavity and Sinuses 15 years 60 years Both J30.9 J01.9 Allergic rhinitis, unspecified Acute sinusitis, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Patients are treated with oral tablets (single dose of co amoxiclav 325 mg per day in bacterial rhinosinusitis and fexofenadine 180 in allergic rhinosinusitis). They also receive a solution containing normal saline isotonic as a placebo. Intervention group 1: Patients are treated with a topical solution containing a micro emulsion prepared with flaxseed oil plus an oral tablet (single dose of co amoxiclav 325 mg in bacterial rhinosinusitis and fexofenadine 180 in allergic rhinosinusitis). Intervention group 2: Patients are treated with a topical solution containing flax seed oil micro emulsion and placebo oral tablets. Inflammation of the mucosa of the rhino sinus cavity. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: Visual Analogue Scale. Headache. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Pressure and capillaries (the nose and paranasal sinuses). Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Sputum secretions. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Itching and runny nose. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Congestion and olfactory disorder. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Fever, cough and phlegm. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Questionnaire (Based on patient self-expression). Swelling of the mucosa. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Examination. Redness of the mucosa. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Examination. Mucosal lesions. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Examination. Mucosal ulcers. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Examination. BMS Science and Research group Approved 2021-06-19 Ethics committee of Alborz University of Medical Sciences Deputy of Research and Technology, Saffarian Alley, 45 meters of Golshahr Karaj Alborz Iran (Islamic Republic of)