Evaluation of the effects of solution made with flax seed oil in the treatment of rhinosinusitis

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2021
INTERVENTION: 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. CONDITION: Condition 1: Rhinitis. Condition 2: Sinusitis. ; Allergic rhinitis, unspecified ; Acute sinusitis, unspecified J01.9 J30.9 PRIMARY OUTCOME: 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. SECONDARY OUTCOME: 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). Headache. 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). 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. 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). Redness of the mucosa. Timepoint: Before the intervention, one week after the intervention. Method of measurement: Examination. Sputum secretions. 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. INCLUSION CRITERIA: 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
Epistemonikos ID: 5800462c661235b56d36d9930b696dd7b1f9ac78
First added on: Sep 13, 2021