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Comparative survey of the effectiveness of topical injection of Triamcinolone and Jelfum with Triamcinolone on reducing the symptoms of patients with allergic rhinitis

Protocol summary

Study aim
Determining the effectiveness of triamcinolone and the combination of jelfum with triamcinolone on reducing the symptoms of patients with allergic rhinitis
Design
This study is a randomized controlled clinical trial of the parallel type of phase 1.which the allocation of individuals in the group is equal and random, in other words, the allocation ratio in this study is equal to one. For random allocation of patients in each group, the block randomization method with unequal blocks (for example, 2, 4, 6, etc.) will be used and in each block, an equal number of each group will be placed.
Settings and conduct
Patients with allergic rhinitis referred to the clinic of Imam Khomeini Hospital in Kermanshah city, are divided into 3 groups and the first group is given triamcinolone by injection in the septum, In the second group, Jelfum impregnated with triamcinolone is placed intranasally in the middle meatus of the nose, and the third group is routinely treated. And after some time by the project assistant, the patient's symptoms are recorded and compared in all 3 groups. The study is a parallel randomized controlled clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ARIA criteria for the diagnosis of allergic rhinitis Exclusion criteria: history of rhinoplasty, anatomical disorders of the nose, persistent asthma, Prolonged use of corticosteroids, tuberculosis, diabetes, other chronic systemic diseases and pregnancy
Intervention groups
In the first group is given Triamcinolone by injection into the septum, the second group, Jelfum impregnated with triamcinolone is placed intranasally in the middle meatus of the nose, and the third group is routinely treated.
Main outcome variables
Sneezing; runny nose; Nasal congestion; Itchy nose

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210915052490N1
Registration date: 2021-10-10, 1400/07/18
Registration timing: registered_while_recruiting

Last update: 2021-10-10, 1400/07/18
Update count: 0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
Amrollah Dehghanifirouzabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3823 4604
Email address
amrollah.dehghani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-04, 1400/06/13
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative survey of the effectiveness of topical injection of Triamcinolone and Jelfum with Triamcinolone on reducing the symptoms of patients with allergic rhinitis
Public title
Effect of Triamcinolone and Jelfum in reducing the symptoms of allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ARIA Criteria Diagnosis of allergic rhinitis
Exclusion criteria:
History of rhinoplasty Anatomical disorders of the nose Persistent asthma Prolonged use of corticosteroids Tuberculosis Diabetes Chronic systemic diseases Pregnancy
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization method with unequal blocks (for example 2, 4, 6, etc.) will be used - Randomization unit: individual - How to build a random sequence: An equal number of each group will be placed in each block. In this way, first the list of all permutations related to the size of the desired block is determined and then will be randomly selected as many as the number of sample from permutation - Randomization tool: Random generation and selection of permutations done using reputable sites generate a block randomization list. Such as https://www.sealedenvelope.com - Hide method: use the envelope in the package
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Kermanshah University of Medical Sciences
Street address
Deputy of Research and Technology- Building No. 2 - Shahid Beheshti Boulevard - Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-08-31, 1400/06/09
Ethics committee reference number
IR.KUMS.REC.1400.464

Health conditions studied

1

Description of health condition studied
Allergic Rhinitis
ICD-10 code
J30.8
ICD-10 code description
Other allergic rhinitis

Primary outcomes

1

Description
Sneezing
Timepoint
At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the intervention.
Method of measurement
Based on question from the person (The rate of patient sneezing based on the number of episodes of the patient's daily sneezing)

2

Description
runny nose
Timepoint
At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the intervention.
Method of measurement
Based on a question from the person (number of sheets of tissue paper consumed by the patient per day)

3

Description
Nasal congestion
Timepoint
At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the intervention.
Method of measurement
Based on the scores that patient gives to these symptoms from zero to three

4

Description
Itchy nose
Timepoint
At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the intervention.
Method of measurement
Based on the scores that patient gives to these symptoms from zero to three

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Half a cc of Triamcinolone 40 ml Per mg is injected into the septum.
Category
Treatment - Drugs

2

Description
Intervention group: Jelfum impregnated with triamcinolone is placed Intranasally in the Middle meatus of the nose Both nostril nasal By Zero degree endoscope
Category
Treatment - Drugs

3

Description
Control group: This group is treated routinely. Routine treatment will be washing serum and then nasal fluticasone spray, 2 puffs per nostril, every 6 hours (200 mg per day).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Kermanshah
Full name of responsible person
Amrollah Dehghani
Street address
Imam Khomeini Hospital - Transportation Street - Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
ihosp@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Deputy of Research and Technology- Building No. 2 - Shahid Beheshti Boulevard - Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719995364
Phone
+98 83 3838 4185
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Amrollah Dehghani
Position
Assistant Professor of Otorhinolaryngology
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
School of Medicine - University Street - Shahid Shiroodi Boulevard - Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Email
amrollah.dehghani@kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amrollah Dehghani
Position
Assistant Professor of Otorhinolaryngology
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
School of Medicine - University Street - Shahid Shiroodi Boulevard - Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Email
amrollah.dehghani@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sharmin Rahmani
Position
Researcher of Imam Khomeini Hospital Research Unit, Kermanshah
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Imam Khomeini Hospital - Transportation Street - Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 2049
Email
sh.rahmani90@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
All researchers
Under which criteria data/document could be used
Use for future research
From where data/document is obtainable
Kermanshah University of Medical Sciences
What processes are involved for a request to access data/document
By Email
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