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IRCT20220104053625N1 IRCT 2022-01-10 Iran University of Medical Sciences Evaluation of the effect of topical aminophylline in hyposmic and anosmic patients Evaluation of the effect of topical aminophylline in hyposmic and anosmic patients referred to the ENT clinic in Firoozgar hospital in 2020-2021 2022-02-07 anticipated 40 Complete https://irct.ir/trial/61145 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups A and B by simple randomization method (using flip the coin method), In this way, the third person out of the study, based on the coin toss 40 times, classifies the milk patients in group A and the line in group B and is placed in a non-transparent closed envelope. Each participant is then given an envelope in order of reference. The third person throwing the coin does not know the drugs used in the groups and how the A.B. is divided. Random allocation: Deciding whether to accept or reject a company The study was first based on olfactory score and informed consent form by participants Is completed and then the participants to each The groups are randomly assigned and have no knowledge of the drugs in each group. People who work at the patient distribution center have no knowledge of our research, Blinding description: Participating patients did not know the contents of the drops. The third person, independent of the research team, encodes the drops containing the drug and the placebo. As a result, the person who delivers the drops and the person who collects the information have no information about the study group. The person analyzing the data also has no knowledge of the relevant coding. 3 Patient with Post viral hyposmia. Intervention 1: Intervention group: Aminophylline drops (using the contents of the vial aminophylline in the form of nasal drops, 250 micrograms daily) ,8 drops were used daily on each side of the nose in a head down and back position for 3 month with olfactory training. Olfactory training was performed using four reagents with different odors, including rose, eucalyptus, lemon, and cloves. Each odorant was smelled for 10s/time, and the interval between two odorants was 10s. the training frequency was one time before breakfast and one time before sleep everyday , for 3 months. Intervention 2: Control group: given normal saline drops with olfactory training over a three-month period.8 drops were used daily on each side of the nose with olfactory training. 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 No data
public Pardis Rahimi
Firoozgar hospital., Valiasr Ave., Tehran Town
Tehran Iran (Islamic Republic of) 1345617615 +98 21 6637 2369 Pardiss.rahimi@gmail.com Iran University of Medical Sciences scientific Hesam Jahandideh Sabet
Firoozgar hospital., Valiasr Ave., Tehran Town
Tehran Iran (Islamic Republic of) 1345617615 +98 21 6637 2369 h.jahandideh@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) patients older than 18 years diagnosis of post viral hyposmia or anosmia, the course of olfactory dysfunction was > 6 months signing the written informed consent to participate study 18 years no limit Both lack of proper compliance to the prescribed drugs history of nasal or skull base surgeries, history of nasal polyps, history of facial or nasal trauma allergies to aminophylline or theophylline consumption of other drugs. R43.0 Anosmia Treatment - Drugs Placebo Intervention group: Aminophylline drops (using the contents of the vial aminophylline in the form of nasal drops, 250 micrograms daily) ,8 drops were used daily on each side of the nose in a head down and back position for 3 month with olfactory training. Olfactory training was performed using four reagents with different odors, including rose, eucalyptus, lemon, and cloves. Each odorant was smelled for 10s/time, and the interval between two odorants was 10s. the training frequency was one time before breakfast and one time before sleep everyday , for 3 months. Control group: given normal saline drops with olfactory training over a three-month period.8 drops were used daily on each side of the nose with olfactory training Patients' olfactory level. Timepoint: Before the intervention and three months after taking the drops. Method of measurement: SIT (smell identification test). Iran University of Medical Sciences Approved 2020-02-04 Ethics Committee of Iran University of Medical Sciences Rasool akram Hospital., Niayesh Ave., Sattarkhan Ave., Tehran Town Tehran Tehran Iran (Islamic Republic of)