Protocol summary

Study aim
Determination of mean score of symptoms and quality of life in the intervention group with triamcinolone before and after intervention Determination of mean score of symptoms and quality of life in control group before and after intervention Comparison of mean score of symptoms and quality of life after intervention in two groups
Design
In this study, 100 patients who have undergone rhinoplasty due to allergic rhinitis who are referred to Khatam-ol-Anbia Hospital will be included in the study after explaining the study conditions and obtaining informed consent. After completing the rhinoplasty, the patients completed the questionnaire before the rhinoplasty, and randomly ( by selecting a card from inside the bag containing 50 A cards and 50 B cards) into two groups receiving triamcinolone and the control group , Will be divided.
Settings and conduct
In this study, 100 patients who have undergone rhinoplasty due to allergic rhinitis who visit Khatam-ol-Anbia Hospital will be included in the study after explaining the study conditions and obtaining informed consent. After completing the rhinoplasty, the patients completed the questionnaire before the rhinoplasty, and randomly ( by selecting a card from inside the bag containing 50 A cards and 50 B cards) into two groups receiving triamcinolone and the control group . In the recipient group, 20 mg of triamcinolone per day will be injected into each lower nasal concha, and no drug will be used in the control group. Finally, one month after injection, symptoms and quality of life of patients are calculated using the standard questionnaire of symptoms and quality of life in patients with allergic rhinitis and will be recorded in a form of information. Blind: Due to the fact that the intervention is performed during and after anesthesia, the intervention or non intervention group does not know about the intervention.
Participants/Inclusion and exclusion criteria
Major entry into the study includes all patients who undergo rhinoplasty as a result of allergic rhinitis. Major exclusion criteria include a history of respiratory infections in the past 1 month, systemic illness, alcohol consumption, pregnancy or lactation, corticosteroid therapy, mental disorder.
Intervention groups
in intervention group,20 mg of triamcinolone per day will be injected into each lower nasal concha, and no drug will be used in the control group.
Main outcome variables
Determination of the effect of triamcinolone acetate injection on the lower branches of the nose in improving symptoms and quality of life of patients with allergic rhinitis under rhinoplasty

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171008036655N2
Registration date: 2018-02-23, 1396/12/04
Registration timing: registered_while_recruiting

Last update: 2018-02-23, 1396/12/04
Update count: 0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 750 5055
Email address
m.mohammadi1370@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of triamcinolone acetate injection in the lower branches of the nose in improving the symptoms and quality of life of patients with allergic rhinitis undergoing rhinoplasty
Public title
Investigating the effect of triamcinolone acetate injection in the lower branches of the nose in improving the symptoms and quality of life of patients with allergic rhinitis undergoing rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Major entry into the study includes all patients undergoing rhinoplasty due to allergic rhinitis in year 96-97.
Exclusion criteria:
Major exclusion criteria include a history of respiratory infections in the past 1 month, systemic illness, alcohol consumption, pregnancy or lactation, corticosteroid therapy, mental disorder.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment method: For random assignment, 50 cards A and 50 cards B are inserted into the bag and after completing the pre-operation questionnaires, the patient is asked to remove one of these cards if the card A is selected The intervention group and if the card B is selected, it will be allocated to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the intervention is performed during and after anesthesia, the intervention or non-intervention group is not aware of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Zahedan, Dr. Hassabi Square, Persian Gulf Blvd, Campus Complex, Zahedan University of Medical Sciences and Health Services
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3000123155
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.ZAUMS.REC.1396.127

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
Score of symptoms and quality of life
Timepoint
Complete the questionnaires before and one month after the injection
Method of measurement
Standard questionnaire of symptoms and quality of life in patients with rhinoconjunctivitis

Secondary outcomes

1

Description
Score of symptoms and quality of life
Timepoint
Complete the questionnaires before and one month after the injection
Method of measurement
Standard questionnaire of symptoms and quality of life in patients with rhinoconjunctivitis

Intervention groups

1

Description
Intervention group: In the intervention group, 20 mg of triamcinolone will be given intraoperatively in each lower nasal concha.
Category
Treatment - Surgery

2

Description
Control group: No drugs will be used.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital
Full name of responsible person
Dr. Gholamali Dashti
Street address
Khatam Al Anbia Hospital,Jam Jam Street,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3000709050
Phone
+98 54 3322 0501
Fax
Email
drdashti50@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hooshang Rafiqdoust
Street address
Office of Health Services,Persian Gulf Blvd, Dr. Hesabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3000123155
Phone
+98 54 3329 5715
Email
mohamad.mohamadi1370@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Dashti
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Office of Health Services,Persian Gulf Blvd,Dr. Hesabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3000123155
Phone
+98 54 3329 5715
Email
drdashti50@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Dashti
Position
ENT
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Office of Health Services,Persian Gulf Blvd,Dr. Hesabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3000123155
Phone
+98 54 3329 5715
Email
drdashti50@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Dashti
Position
ENT
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Office of Health Services,Persian Gulf Blvd,Dr. Hesabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3000123155
Phone
+98 54 3329 5715
Email
drdashti50@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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