Evaluation of the effectiveness of topical estrogen on non allergic rhinitis in postmenopausal women
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. Excel software rand function was used for randomization.
Settings and conduct
The drug and placebo were prepared in the same package and given to patients in both groups.The chief physician, researcher and statistical specialist is not aware of the patient group.
Participants/Inclusion and exclusion criteria
Menopausal women 12 months after their last menstrual bleeding; symptoms of nasal congestion (feeling of fullness in the nose, feeling of discomfort and heaviness in the nose - feeling of reduced airflow in the nose, loss of smell or mouth breathing).
Intervention groups
Intervention group: take intra nasal conjugated estrogen ointment daily (50 mg containing 300 micrograms of estrogen) for 3 months; control group treated with lanolin 50 mg daily for 3 months.
Main outcome variables
Improving nasal airflow in rhinomanometry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200926048841N2
Registration date:2022-05-16, 1401/02/26
Registration timing:prospective
Last update:2022-05-16, 1401/02/26
Update count:0
Registration date
2022-05-16, 1401/02/26
Registrant information
Name
mahboobe asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2640 5257
Email address
ma_asadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of topical esterogen on non allergic rhinitis in post menopausal women
Public title
Estrogen in non allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women 12 months after their last menstrual bleeding
Symptoms of nasal congestion (feeling of fullness in the nose, feeling of discomfort and heaviness in the nose - feeling of reduced airflow in the nose, loss of smell or mouth breathing)
Exclusion criteria:
Use of drugs affecting the nasal airway and nasal mucosa (systemic and local)
Systemic underlying diseases
Previous history of rhinoplasty and sinus surgery
Obstructive symptoms before menopause
Presence of known sinonasal diseases, including pulpitis, chronic sinusitis, sinonasal tumors (both benign and malignant)
Smoking and inhaled drugs
Occupational exposure to chemical stimulants and its history
Patients wاho did not have the proper cooperation for rhinomanometry, endoscopy and the use of drugs and follow-up
Patients for whom estrogen use is contraindicated
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method. Given the block size of 2, there are two ways to assign participants to a block. AB or BA. (A) stands for topical estrogen (B) stands for no topical estrogen. Using Microsoft Excel software we produce 33 numbers equal to the sample size in each group between 0 to 10. For numbers 0, 2, 4, 6, 8, AB combination and for numbers 1, 3, 5, 7, 9, BA combination are chosen.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and physician is not aware of the patient's group; also researchers and the study statisticians were masked to treatment allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hearing Disorders Research center of Shahid Beheshti University of Medical Si
Street address
Hearing Disorders Research center, Loghman Hakim hospital, Kamali ave., South Kargar ave.
City
Tehran
Province
Tehran
Postal code
1916665354
Approval date
2021-10-23, 1400/08/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.025
Health conditions studied
1
Description of health condition studied
Vasomotor rhinitis
ICD-10 code
J30.0
ICD-10 code description
Vasomotor rhinitis
Primary outcomes
1
Description
Effect of estrogen on rhinitis
Timepoint
Three months after treatment
Method of measurement
Rhinomanometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Take intra nasal conjugated estrogen ointment daily(50 mg containing 300 micrograms of estrogen) for 3 months.
Category
Treatment - Drugs
2
Description
Control group: They were treated with intranasal lanolin (oil used as a base for estrogen ointment)daily (50mg)for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Mahboobe Asadi
Street address
Velenjak, Erabi Ave
City
Tehran
Province
Tehran
Postal code
191666354
Phone
+98 21 2303 1317
Email
mahboobeh_farvardin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziai
Street address
Evin,Shahid Shahriary square.
City
Tehran
Province
Tehran
Postal code
193954719
Phone
+98 21 2243 9951
Email
aliziai@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Assistant of Shahid Beheshty University of medical sciences
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Asadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Velenjak, Erabi ave.
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 2303 1317
Email
mahboobeh_farvardin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Asadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Velenjak, Erabi ave.
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 2303 1317
Email
mahboobeh_farvardin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Asadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Velenjak, Erabi ave.
City
Tehran
Province
Tehran
Postal code
1916665354
Phone
+98 21 2303 1317
Email
mahboobeh_farvardin@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
Participant data sets are to be shared
When the data will become available and for how long
These data files will become available one year after publication
To whom data/document is available
The data is only available for people working in academic institutions
Under which criteria data/document could be used
The data is only available for people working in academic institutions
From where data/document is obtainable
The data is obtainable from the corresponding author via email
What processes are involved for a request to access data/document
The data is obtainable from the corresponding author via email