The aim of current study is to evaluate the effect of high and low dose prednisolone on the symptoms of patients with granulomatous mastitis.
Design
Clinical trial study, with parallel groups, double blinded, randomized
Settings and conduct
Thirty female patients with granulomatous mastitis were randomly assigned to two groups of 15 patients.First group received prednisolone 5 mg daily for two months and second group received prednislone 50 mg for 3 days, then 25 mg for 3 days, then 12.5 mg for 3 days and 5 mg daily afterwards till the end of two months. The outcome and response to treatment was compared between groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with Idiopathic granulomatous mastitis, age > 18 years. Exclusion criteria: Pregnant women, women with non-idiopathic granulomatous mastitis, infectious diseases and allergies and contraindications to use corticosteroids.
Intervention groups
Intervention group 1: Low dose prednisolone. Intervention group 2: High dose prednisolone.
Main outcome variables
Response to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120605009948N8
Registration date:2019-10-13, 1398/07/21
Registration timing:retrospective
Last update:2019-10-13, 1398/07/21
Update count:0
Registration date
2019-10-13, 1398/07/21
Registrant information
Name
Majid Montazer
Name of organization / entity
Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 8435
Email address
montazerma@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-19, 1396/01/30
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
2017-09-06, 1396/06/15
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2020-02-19, 1398/11/30
Scientific title
Comparison of the outcome of low dose and high-dose corticosteroid in the treatment of granulomatous mastitis
Public title
the outcome of low dose and high-dose corticosteroid in the treatment of granulomatous mastitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with Idiopathic granulomatous mastitis
age > 18 years
Exclusion criteria:
Pregnant women
women with non-idiopathic granulomatous mastitis
women with infectious diseases and allergies
contraindications to use corticosteroids
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are simply randomized to two groups through random number table; received a special code and are treated with own group treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be as patients will randomly allocated to two treatment groups and each patient will receive sealed envelope named A or B including the defined treatment and patients will not be aware of the contents of the each envelope. Physician responsible for labeling the envelopes will not interfere with the study and other physician will asses the treatment outcome unaware of the contents of the envelopes. Data will present to statistical analyzers as A & B groups. They will be blinded about the intervention and placebo groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Scienes, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
1476651666
Approval date
2017-03-02, 1395/12/12
Ethics committee reference number
IR.TBXMED.REC.1397.592
Health conditions studied
1
Description of health condition studied
granulomatous mastitis
ICD-10 code
N61
ICD-10 code description
Inflammatory disorders of breast
Primary outcomes
1
Description
Response to treatment
Timepoint
Before and two months after treatment
Method of measurement
physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Prednisolone will be administered 5 mg daily for two months
Category
Treatment - Drugs
2
Description
Intervention group: Prednisolone will be administered 50 mg per day for 3 days, 25 mg for 3 days, 12.5 mg for 3 days and 5 mg daily afterwards till the end of two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Majid Montazer Bavil
Street address
Imam Reza Hospital, Golgasht St., Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3334 7056
Email
info@imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University of Medical Sciencesm Azadi Ave.,
City
Tabriz
Province
East Azarbaijan
Postal code
1476651666
Phone
+98 41 1334 1705
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahid Montazer Bavil
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3335 7852
Email
montazerma@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer Bavil
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3335 7852
Email
montazerma@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer Bavil
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615556
Phone
+98 41 3335 7852
Email
montazerma@tbzmed.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
We have not yet set a conclusion
When the data will become available and for how long
We have not yet set a conclusion
To whom data/document is available
We have not yet set a conclusion
Under which criteria data/document could be used
We have not yet set a conclusion
From where data/document is obtainable
We have not yet set a conclusion
What processes are involved for a request to access data/document