The effect of nasal spray based on herbal extracts (traditional Persian medicine product) compared to placebo on the symptoms of patients with allergic rhinitis

Determination of the effect of Nasal spray based of herbal extracts(An Iranian Traditional Medicine product) on treatment of allergic rhinitis

Clinical trial with control group, with parallel groups, triple-blind, randomized, phase 2-3 on 76 patients. Permutation blocks are used for randomization.

The patients referred to the Iranian Medicine Clinic of Imam Reza (AS) Hospital who suffer from allergic rhinitis were selected. In patients who did not receive treatment for allergic rhinitis for at least one week, the rhinitis-control-assessment-tes(RCAT) and Total Nasal Symptom Score(TNSS) questionnaires were completed and then three weeks of treatment was performed. The TNSS questionnaire is completed again. For relapses, the RCAT questionnaire will be completed one week after the end of treatment.

All patients 18 years to 70 years old that according to the َAllergic Rhinitis and its Impact on Asthma(ARIA) guideline and diagnosis of a Clinical Immunologist and a Possitive Perik Test have allergic rhinitis. No entry criteria: Diffused Nasal Polyps; Pregnancy; history of allergy to Coriander or Bitter orange; Asthma; systemic inflammatory diseases; using antihistamines during the last week before the beginning of the study; using Corticosteroids during the last 2 weeks before the beginning of the study; Lack of consent from the patient to stay in the study for any reason.

In the intervention group, nasal spray is given in 2 puffs every 8 hours for 3 weeks In the control group, placebo nasal spray is given in 2 puffs every 8 hours for 3 weeks

Sneezing, Rhinorrhea, Nasal Congestion, Itchy nose

Randomization of patients: drug and placebo in the same appearance and package are randomly given to patients in two groups A and B. Randomization of the clinical caregiver: Blocking using permutation block method using the site https://www.sealedenvelope.com with the explanation that each of the blocks has 4 members and the shape of the blocks is as follows: [AABB], [ABAB], [ABBA], [BABA], [BBAA], [BAAB] The above-mentioned site randomly selects seventeen blocks from blocks of four, so that finally 76 patients are included in the study. Randomization of the researcher: The researcher analyzes the patients in two groups A and B.

Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.

After the end of the research, the results will be published in the form of an original article in an international journal and will be available to other researchers. Access to the raw data collected in this study will be possible after obtaining permission from the principal investigators and the corresponding author. Research use in the form of publishing a new article from the data in this study requires written permission from the researchers of the current study.

From the time of publication of the article until one year later

Academic researchers by request from the corresponding author

Access to the raw data collected in this study will be possible after obtaining permission from the lead researchers and the responsible author. Research use in the form of publishing a new article of the data in this study requires the written permission of the researchers of current study.

Applicants can communicate with the corresponding author via email at farabia971@mums.ac.ir.

An email containing the introduction of the requester and the explanation of the reason for the request and the description of possible uses will be sent to the corresponding author. If accepted by the corresponding author, the requested information will be sent to the requester via email.