Determining and comparing the effect of three non-surgical treatments of Idiopathic Granulomatous Mastitis
Design
Design: Phase 3, multi-center, clinical trial on 147 patients who will be randomly divided into 3 groups. Patients will be assigned to three groups based on the city in which they live. Patients will be followed up every three weeks for three months. At the end of three months, if the clinical symptoms are completely cured, they will be considered as successful treatment. If the disease progresses or the symptoms do not improve will be considered as "refractory".
Settings and conduct
This multicenter study will be conducted in different cities. Since the project is implemented in several centers across the country, all of the centers will be coordinated by the project manager. the project manager will be in regular contact with all participating centers and will assess the correct completion of forms and on-time visits of patients. She will report regularly to the head of the research project. The study variables will be recorded in special checklists during each visit.
Blinding: None.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pathological diagnosis of Granulomatous Mastitis
Exclusion criteria: fungal infection, concomitant tuberculosis, systemic symptoms including fever (not due to superinfection of mastitis granulomatosis), polyarthritis or polyarthralgia, generalized lymphadenopathy
Intervention groups
Group 1: Prednisolone
Group 2: Colchicine
Group 3: Naproxen and topical Plantago major ointment
Main outcome variables
Ulcer; Fistula; Erythema size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100706004329N10
Registration date:2021-05-07, 1400/02/17
Registration timing:prospective
Last update:2021-05-07, 1400/02/17
Update count:0
Registration date
2021-05-07, 1400/02/17
Registrant information
Name
Sadaf Alipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982177888751 - 00982177883195
Email address
salipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
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
Comparison of the effects of three types of non-surgical treatments in the management of idiopathic Granulomatous Mastitis
Public title
Non-surgical treatment of Granulomatous Mastitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pathological diagnosis of Granulomatous Mastitis
Exclusion criteria:
Fungal infection
Tuberculosis
Systemic symptoms including fever (not due to super infection of Granulomatous Mastitis)
Polyarthritis or Polyarthralgia
Generalized lymphadenopathy
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
147
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 Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1400.012
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
Ulcer
Timepoint
Before the intervention and then every three weeks to three months
Method of measurement
Examination
2
Description
Fistula
Timepoint
Before the intervention and then every three weeks to three months
Method of measurement
Examination
3
Description
Size of Erythema
Timepoint
Before the intervention and then every three weeks to three months
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: They will take Prednisolone 15 mg daily, and in case of treatment refractory, they will take Prednisolone at a dose of 30 mg.
Category
Treatment - Drugs
2
Description
Intervention group 2: They will take 1 mg of colchicine twice a day, and in case of treatment refractory, they will take Prednisolone at a dose of 30 mg.
Category
Treatment - Drugs
3
Description
Intervention group: They will take Naproxen 250 mg twice daily (for 2 weeks only) and topical Plantago major ointment, and in case of treatment-refractory, the steroid will be injected into the lesion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr Sadaf Alipour
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
salipour@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
6th floor, Central University, Qods St, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8838 8988
Fax
+98 21 8838 8988
Email
resdeputy@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sadaf Alipour
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
salipour@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadaf Alipour
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
00982177888751 - 00982177883195
Fax
+98 21 7788 3196
Email
salipour@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadaf Alipour
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
salipour@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The research team has not yet decided about the publication of participants' data.
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