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IRCT20190804044429N6 IRCT 2021-02-20 Mazandaran University of Medical Sciences Nasal spray of mometasone 0.05% effects on olfactory improvement in COVID-19 Efficacy and safety of nasal spray of mometasone 0.05%on olfactory improvement in patients with COVID-19: A randomized, double blind clinical trial 2021-02-18 anticipated 60 Complete https://irct.ir/trial/54008 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A master randomization schedule was prepared by a person not associated with the study who used permuted blocks of random numbers. The medicine bottles and identical placebo were the same regarding size and color. Randomization was incorporated in the serially numbered bottles containing drug or placebo by person not involved with the study according to random numbers. The number of the bottle corresponded with the number of the patient, Blinding description: This study is double blind. Outcome elevator and participant are blinded (double blind) and aware from grouping (intervention or placebo). 2-3 Anosmia. Intervention 1: Intervention group: Mometasone nasal spray 0.05% by Sina daru pharmaceutical company as one puff every 12 hours for one month. Intervention 2: Control group: sodium chloride nasal spray 0.65% by Sina daru pharmaceutical company as one puff every 12 hour for one month. Yes - There is a plan to make this available What will be shared: The results of trial including analysis data and method of the study When: At the time of publication, the data of the study will be available. To whom: academic researchers, medical team and scientific institutes Conditions: For research and practical purposes Where to obtain: Dr. Monireh Ghazaeian, Faculty of pharmacy, Mazandaran University of Medical Sciences How to obtain: The scientific responsible person of the study will reply to the request within 10 days. ghazaeianm@gmail.com Comments:
public Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran.
Sari Iran (Islamic Republic of) 4815733971 +98 11 3334 3011 ghazaeianm@gmail.com Mazandaran University of Medical Sciences scientific Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd
Sari Iran (Islamic Republic of) 48157-33971 +98 11 3334 3010 ghazaeianm@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria are adults over the age of 18 with a diagnosis of COVID-19 based on clinical criteria (presence of any symptoms of cough, shortness of breath, fever, and CT scan of the lung for evidence of involvement consistent with COVID-19 infection) or PCR and had an olfactory dysfunction ( reduced or loss of sense of smell) for two weeks 18 years no limit Both Pregnancy and lactation History of olfactory dysfunction Taking drugs that affect the olfactory disorders Corticosteroids chronic use Nasal anatomic dysfunction Existence of dry ducts or nasal bleeding Existence of herpetic lesion Dissatisfaction with participating in the study R43.0 Anosmia Treatment - Drugs Other Intervention group: Mometasone nasal spray 0.05% by Sina daru pharmaceutical company as one puff every 12 hours for one month. Control group: sodium chloride nasal spray 0.65% by Sina daru pharmaceutical company as one puff every 12 hour for one month. Olfactory symptoms improvement. Timepoint: before intervention and one month later. Method of measurement: Pennsylvania score and Visual Analogue Scale. Safety of mometasone nasal spray. Timepoint: weekly during the study. Method of measurement: patient tolerability. Olfactory symptoms improvement duration. Timepoint: End of treatment. Method of measurement: Patient interview. Determination of effective patient factors on olfactory dysfunction. Timepoint: study period. Method of measurement: patient interview. Mazandaran University of Medical Sciences Approved 2021-01-31 Mazandaran University of Medical Sciences Ibn Sina Hospital, Pasdaran Blvd Sari Mazandaran Iran (Islamic Republic of)