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

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.

Clinical trial with control group and two intervention groups 1 and 2, three blind strains, non-randomized, phase 2-3, on 99 patients, uses the Covariate Adaptive Randomization (CAR) method to distribute confounding variables to the study groups.

The research is will perform in the hospitals clinic of Alborz University of Medical Sciences. After taking a history, the ENT specialist examines the patients and selects the desired samples in case of a definite diagnosis of Rhinosinusitis. After introducing and obtaining consent according to the CAR method, patients are placed in one of the three intervention groups and patients are evaluated in several stages. The letters A and B are used on the drugs, so the analyzer, patients and physician are not aware of the treatment method.

Inclusion criteria include all rhinosinusitis patients over 15 years of age and under 60 years of age, lack of sensitivity to herbal medicines and no use of anti-inflammatory and antimicrobial drugs during the last week ,also Rhinosinusitis patients with specific underlying diseases and Coronavirus involvement are not included in the study.

Patients are intervened in three groups. In the control group, patients are treated with conventional oral tablets. In intervention group 1 Patients are treated with a topical solution containing micro emulsion made with flaxseed oil with conventional oral tablets. In intervention group 2 patients are treated with topical solution containing micro emulsion of flaxseed oil.

Inflammation of the mucosa of the Rhino sinus cavity

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.