This is a randomized controlled clinical-trial double-blinded and the aim of current study is assessing therapeutic effect of intranasal insulin on hyposmic patients. Inclusion criteria: hyposmic patients with CCCRC scores 2 to 5.75; patients not are under general anesthesia in this treatment; don't use corticosteroid in treatment duration; patients aren't hypoglycemia or diabetes; patients' willingness to participate in the study.
exclusion criteria: patients that cant't follow up in four months after treatment and haven't willingness to continue the study.
this study will be administer on 36 hyposmic patients according to inclusion and exclusion criteria. Afterward patients will be enroll in the study. Also
Patients with hyposmia should be confirm using Connecticut Chemosensory Clinical Research Center (CCCRC) criteria. Patients will randomly be divide to two groups of patients under treated with intranasal insulin or intervention group and patients under treated intranasal normal saline or placebo group. CCCRC test will be do prior to, within 12 hours, within 4, 8 and finally 16 weeks after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061712782N15
Registration date:2017-07-09, 1396/04/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-09, 1396/04/18
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Isfahan University of Medical Sciences .
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intranasal insulin administering on returning of the smell in patients with hyposmia.
Public title
Effect of intranasal insulin administering on patients with loss of smell
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hyposmic patients with CCCRC scores 2 to 5.75; patients not are under general anesthesia in this treatment; don't use corticosteroid in treatment duration; patients aren't hypoglycemia or diabetes; patients' willingness to participate in the study.
exclusion criteria: patients that cant't follow up in four months after treatment and haven't willingness to continue the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of medical sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MUI.REC.1395.30999
Health conditions studied
1
Description of health condition studied
Hyposmia
ICD-10 code
R43
ICD-10 code description
Disturbances of smell and taste
Primary outcomes
1
Description
Intensity of smell
Timepoint
before intervention and four months after intervention
Method of measurement
Connecticut Chemosensory Clinical Research Center test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients under treated with intranasal insulin
Category
Treatment - Drugs
2
Description
Control group: patients under treated with normal saline intranasal
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Ahmad Rezaeian
Street address
Alzahra hospital, Alzahra street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan University of medical sciences,Hezar jarib street, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of medical sciences, Isfahan, Iran.
Full name of responsible person
Dr Ahmad Rezaeian
Position
Otorhinolaryngologist/ Assistant professor
Other areas of specialty/work
Street address
Isfahan University of medical sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
dr.ahmadrezaeian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of medical sciences.
Full name of responsible person
Dr Ahmad Rezaeian
Position
Assistant professor of Otorhinolaryngology
Other areas of specialty/work
Street address
Isfahan University of medical sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
dr.ahmadrezaeian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Medical Sciences
Full name of responsible person
Ali Mehrabi Koushki
Position
Responsible for research/Master of Science
Other areas of specialty/work
Street address
Research office , Al-Zahra hospital, Al-zahra street, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Phone
+98 31 3265 1574
Fax
Email
Mehrabi@mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)