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IRCT20220517054885N1 IRCT 2022-10-02 Mashhad University of Medical Sciences Investigation of the effect of herbal nasal spray (Iranian Traditional Medicine product) on treatment of allergic rhinitis The effect of nasal spray based on herbal extracts (traditional Persian medicine product) compared to placebo on the symptoms of patients with allergic rhinitis 2022-08-23 anticipated 76 Complete https://irct.ir/trial/63961 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Allergic Rhinitis. Intervention 1: Intervention group: receiving herbal nasal spray made by researchers in the pharmaceutical laboratory of the school of Persian and Complementary medicine of Mashhad University of Medical Sciences containing 1% coriander seed hydroalcoholic extract, 0.5% bitter orange essential oil , 1% pectin, tween and glycerin in the necessary amount; with the order of 2 puffs every 8 hours inside each nasal cavity for 3 weeks. Intervention 2: Control group: receiving a placebo nasal spray made by researchers in the pharmaceutical laboratory of the school of Persian and Complementary medicine of Mashhad University of Medical Sciences containing 1% pectin, tween, and glycerin in the necessary amount and allowed edible color with the order of 2 puffs every 8 hours inside each nasal cavity for 3 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Researchers will try to publish study data in the form of a scientific article.
public Alieh Farabi
School of Persian and Complementary medicine, University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3884 8931 farabia971@mums.ac.ir Mashhad University of Medical Sciences scientific Alireza Derakhshan
School of Persian and Complementary medicine, University Campus, Azadi Square.
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3884 8931 DerakhshanAR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients 18 years to 70 years old that according to the ARIA guideline and diagnosis of a clinical Immunologist have allergic rhinitis 18 years 70 years Both Diffused Nasal Polyps Pregnancy History of allergy to Coriander or Bitter orange Asthmatic patients Systemic inflammatory diseases Using antihistamines during the last week before the beginning of the study Using inhaled corticosteroids during the last 2 weeks before the beginning of the study J30. 9 - A Allergic rhinitis, unspecified Treatment - Drugs Placebo Intervention group: receiving herbal nasal spray made by researchers in the pharmaceutical laboratory of the school of Persian and Complementary medicine of Mashhad University of Medical Sciences containing 1% coriander seed hydroalcoholic extract, 0.5% bitter orange essential oil , 1% pectin, tween and glycerin in the necessary amount; with the order of 2 puffs every 8 hours inside each nasal cavity for 3 weeks Control group: receiving a placebo nasal spray made by researchers in the pharmaceutical laboratory of the school of Persian and Complementary medicine of Mashhad University of Medical Sciences containing 1% pectin, tween, and glycerin in the necessary amount and allowed edible color with the order of 2 puffs every 8 hours inside each nasal cavity for 3 weeks. Nasal obstruction. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Total Nasal Symptom Score questionnaire. Itching/Sneezing. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Total Nasal Symptom Score questionnaire. Rhinorrhea. Timepoint: Baseline and 3 weeks after intervention. Method of measurement: Total Nasal Symptom Score questionnaire. Symptom recurrence rate. Timepoint: Baseline and one week after the end of intervention. Method of measurement: Rhinitis Control Assessment Test (RCAT) questionnaire. Mashhad University of Medical Sciences Approved 2022-08-16 Ethics committee of Mashhad University of Medical Sciences Azadi Square, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)