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Study aim:
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.
Design:
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.
Settings and conduct:
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.
Participants/Inclusion and exclusion criteria:
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.
Intervention groups:
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.
Main outcome variables:
Inflammation of the mucosa of the Rhino sinus cavity