This study compares concomitant application of Azithromycin and corticosteroids with surgical approach usage in Idiopathic Granulomatous Mastitis (IGM) patients. The study is a kind of non-randomized clinical trial, which was implemented without blindness. The target population comprised women whose IGM disease was substantiated. Inclusion criteria involved women with mastitis whose their diseases as IGM were substantiated through biopsy, but they were not treated via any interventional method. Exclusion criteria were composed of dissuasion of individuals for treatment procedures. In medical group, twenty individuals were selected via simple consecutive sampling. However, thirty nine individuals, who had operation of partial mastectomy in their medical history, were retrospectively selected as control group.
In pharmaceutical groups, at first, patients were treated by concomitant application of Azithromycin (250 milligram twice per week) and Prednisolone (40 milligram daily). Afterwards the protocol suggested Prednisolone treatment for eight weeks (40 mg per day) then it was tapered for 6 months. Recurrence of mass in pharmaceutical trial, via physical examination, was followed monthly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013123015999N1
Registration date:2014-01-27, 1392/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-27, 1392/11/07
Registrant information
Name
Roya Taleban
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2542
Email address
r.taleban@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Infectious and Tropical Diseases Research Center
Expected recruitment start date
2012-05-11, 1391/02/22
Expected recruitment end date
2012-11-12, 1391/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Relapse in Idiopathic Granulomatous Mastitis patients treated either by pharmaceutical or surgical approaches
Public title
Relapse Rate in an Inflammatory Disease of Breast Treated by Pharmaceutical and Surgical Approaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women who are well documented Idiopathic Granulomatous Mastitis (IGM) patients via pathological finding, IGM patient being not treated
Exclusion criteria: Dissuasion of individuals for treatment procedures.
Age
From 7 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
59
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Hezar Jarib Ave.,Azadi Sq.
City
Isfahan
Postal code
Approval date
2012-05-10, 1391/02/21
Ethics committee reference number
291163
Health conditions studied
1
Description of health condition studied
Idiopathic Granulomatous Mastitis
ICD-10 code
N61
ICD-10 code description
Inflammatory disorders of breast
Primary outcomes
1
Description
relapse
Timepoint
Patients were monthly examined for 15 months (from initiation of the intervention to 6 months after cessation of the intervention)
Method of measurement
physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention : Azithromycin and Prednisolone concomitant application of Azithromycin (250 milligram twice per week) and Prednisolone (40 milligram daily). Afterwards the protocol suggested Prednisolone treatment for eight weeks (40 mg per day) then it was tapered for 6 months
Category
Treatment - Drugs
2
Description
control:Partial mastectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra University Hospital
Full name of responsible person
Street address
Al-Zahra University Hospital, Sofeh Blvd., 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. Peyman Adibi
Street address
Vice chancellor for research, Isfahan University of Medical Sciences, hezar-jarib St., Azadi Sq., Isfahan
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
Full name of responsible person
Dr. Roya Taleban
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Community Medicine Department, School of Medicine, Isfahan University of medical sciences, Hezar Jarib Ave., َAzadi Sq.
City
Isfahan
Postal code
Phone
+98 31 1792 2542
Fax
Email
r.taleban@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Roya Taleban
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Community Medicine Department, School of Medicine, Isfahan University of medical sciences, Hezar Jarib Ave., َAzadi Sq.
City
Isfahan
Postal code
Phone
+98 31 1792 2542
Fax
Email
r.taleban@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Dr. Roya Taleban
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Community Medicine Department, School of Medicine, Isfahan University of medical sciences, Hezar Jarib Ave., َAzadi Sq.
City
Isfahan
Postal code
Phone
+98 31 1792 2542
Fax
Email
r.taleban@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)