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

Evaluation of the effect of nasal spray based on herbal extracts (a traditional Persian medicine formulation) on the treatment of chronic rhinosinusitis

Randomized double-blind placebo controlled clinical trial on 80 patients, parallel group and Excel software will be used for randomization.

The location of the project is otolaryngology clinics of Valiasr hospital & Imam Ali hospital of Kazeroon. Patients with definite diagnosis of chronic rhinosinusitis entered the study and questionnaires completed for them. Patients were randomly divided into two intervention and control groups (n = 40). In the intervention group, patients treated for 3 weeks by nasal spray with 2 puffs each 8 hours and in the control group they use placebo. Patients, researchers and medical personnel are blinded in this study.

Chronic rhinosinusitis patients without polyposis more than 18 years, with Lund - Mckay more than 3 (moderate to severe rhinosinusitis), which after obtaining informed consent, were included in this research.In addition, patients with history of previous sinus surgery, pregnant or lactating mothers, Samter's triad patients (asthma, allergy and sensitivity to Aspirin, nasal polyposis) and those who are not consented to involved in this research excluded from the study.

In the intervention group, the patients were treated for 3 weeks by herbal nasal spray with 2 puffs each 8 hours and in the control group they use placebo nasal spray which is similar to the intervention group. SNOT22 and RhinoQOL questionnaire at the end of the study were completed for the patients of both groups).

the score of symptoms of sinusitis (headache, cough, sneezing, PND, etc.) based on SNOT22 questionnaire; Score of quality of life of patients based on RhinoQOL questionnaire.

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.

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 .