Determining the effect of aminophylline drops in hyposemic and anosemic patients referred to ENT clinic in Firoozgar hospital.
Design
Phase 3 randomized, parallel group trial with blinded outcome assessment of 40 patient.
Settings and conduct
In this clinical trial that was performed on 40 patients with severe hyposmia or anosmia, patients were randomized into two groups of case and placebo.
In the olfactory center of the ENT department of Firoozgar hospital ,the case group was given aminophylline drops over a three-month period with olfactory training. The control group was given normal saline drops with olfactory training over a three-month period.
Participants/Inclusion and exclusion criteria
Patient with diagnosis of post viral hyposmia or anosmia, the course of olfactory dysfunction was > 6 months enter the study , and those with facial trauma, patients with nasal polyps, and those with a history of aminophylline and theophylline allergies are excluded.
Intervention groups
The case group was given aminophylline drops over three months.
The control group was given normal saline drops with olfactory training over three months.
Main outcome variables
Olfactory status (hyposmia, anosmia), olfactory capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053625N1
Registration date:2022-01-10, 1400/10/20
Registration timing:prospective
Last update:2022-01-10, 1400/10/20
Update count:0
Registration date
2022-01-10, 1400/10/20
Registrant information
Name
Pardis Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6637 2369
Email address
pardiss.rahimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-07, 1400/11/18
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical aminophylline in hyposmic and anosmic patients referred to the ENT clinic in Firoozgar hospital in 2020-2021
Public title
Evaluation of the effect of topical aminophylline in hyposmic and anosmic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Rasool akram Hospital., Niayesh Ave., Sattarkhan Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1345617615
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.IUMS.FMD.REC.1398.477
Health conditions studied
1
Description of health condition studied
Patient with Post viral hyposmia
ICD-10 code
R43.0
ICD-10 code description
Anosmia
Primary outcomes
1
Description
Patients' olfactory level
Timepoint
Before the intervention and three months after taking the drops
Method of measurement
SIT (smell identification test)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Paris Rahimi
Street address
Firoozgar hospital., Valiasr Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1345617615
Phone
+98 21 6637 2369
Email
Pardiss.rahimi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology
Street address
Firoozgar hospital., Valiasr Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1345617615
Phone
+98 21 6637 2369
Email
Pardiss.rahimi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pardis Rahimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Firoozgar hospital., Valiasr Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1345617615
Phone
+98 21 6637 2369
Email
Pardiss.rahimi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hesam Jahandideh Sabet
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Firoozgar hospital., Valiasr Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1345617615
Phone
+98 21 6637 2369
Email
h.jahandideh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pardis Rahimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 10, Emam Ali Ave., Azarbaijan Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1345617615
Phone
+98 21 6637 2369
Email
Pardiss.rahimi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
Start of access period 5 months after printing the results
To whom data/document is available
Researchers working in academic institutions and science
Under which criteria data/document could be used
Research works that have a code of ethics from medical universities are allowed
From where data/document is obtainable
Firoozgar hospital., Tehran
E-mail : Pardiss.rahimi@gmail.com
What processes are involved for a request to access data/document
An email will be sent to the mentioned mailing address as a data requirement, it will be answered within 5 working days