| CTRI Number |
CTRI/2025/11/097028 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the efficacies of treatment regimens in Granulomatous Lobular Mastitis in a tertiary care institute in Eastern India- A Randomized Controlled Trial |
|
Scientific Title of Study
|
Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis - A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tushar Subhadarshan Mishra |
| Designation |
MBBS, MS(General Surgery) |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room no.68, Department of General Surgery, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884251 |
| Fax |
|
| Email |
surg_tushar@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maniteja R |
| Designation |
MBBS |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room no.68, Department of General Surgery, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7619508903 |
| Fax |
|
| Email |
maniteja.ravipati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maniteja R |
| Designation |
MBBS |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7619508903 |
| Fax |
|
| Email |
maniteja.ravipati@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Tushar Subhadarshan Mishra |
| Address |
Room no.68, Department of General Surgery, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar - 751019 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tushar Subhadarshan Mishra |
AIIMS Bhubaneswar |
Department of General Surgery AIIMS Bhubaneswar Sijua Patrapada Bhubaneswar
Khordha
ORISSA |
9438884251
surg_tushar@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N610||Mastitis without abscess, (2) ICD-10 Condition: N611||Abscess of the breast and nipple, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Antibiotics |
Tab. CLARITHROMYCIN 500mg BD + Tab. OFLOXACIN
400mg BD 56 days |
| Intervention |
Corticosteroid |
Tab. PREDNISOLONE 20mg 14 days
Tab. PREDNISOLONE 10mg 21 days
Tab. PREDNISOLONE 5mg 14 days
Tab. PREDNISOLONE 2.5mg 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women histologically diagnosed with GLM willing to participate in the study and to come for follow up. |
|
| ExclusionCriteria |
| Details |
1. Declining to participate in the study
2. Pregnant or lactating women
3. Patient already on antibiotic/steroid therapy and are responding to treatment
4. Known immunosuppression or diabetes mellitus uncontrolled
5. Patient already on immunosuppression therapy for any other disorder
6. Lost to follow-up before 3 months post-treatment
7. Allergic to one of the antibiotics/steroids which will be used
8. Contraindications to oral steroids therapy
9. Contraindications to methotrexate therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of antibiotics vs corticosteroids in achieving Complete Clinical
Response (CCR) in GLM patients at two months of the treatment started in the adaptive randomized arm |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of each treatment regimen. |
2 months |
To assess the role of surgery in the treatment of GLM
A) To determine the proportion patients requiring surgery
B) Quantum of surgery needed (I and D/Resection/mastectomy)
C) Number of patients have recurrence after surgery |
2 months |
To assess the role of combination immunosuppressive therapy in the treatment of
GLM
A) To determine the proportion of patient requiring combination immunosuppressive
therapy
B) Average duration of immunosuppressive therapy required
C) To determine the Indications of immunosuppressive therapy (failure to achieve CCR
within 2 months/Relapse/cure, side effects of primary medications) |
2 months |
| Histological pattern (neutrophilic/lymphocytic) vs Response to therapy |
2 months |
| To have a cause of treatment delay (diagnostic dilemma/improper therapy (wrong antibiotic/wrong steroid/wrong duration) |
2 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The goal of this clinical trial is to find the most effective and safe medical treatment for Granulomatous Lobular Mastitis (GLM) — a rare, chronic inflammatory breast disease that affects young and middle-aged women, often following childbirth. The main questions it aims to answer are: -
Does an antibiotic regimen (clarithromycin, ofloxacin, rifaximin) lead to faster and complete healing (Complete Clinical Response) compared to steroids? -
Do steroids (prednisolone in tapering doses) provide better symptom control or cause more side effects? Researchers will compare the antibiotic group (Group A) and the steroid group (Group B) to see which treatment results in quicker recovery, fewer side effects, and lower recurrence rates. Participants will: -
Receive a 14-day antibiotic trial initially (screening phase). -
If no improvement, be randomly assigned to: -
Group A (Antibiotic therapy) – Clarithromycin, Ofloxacin, Rifaximin for 8 weeks, or -
Group B (Steroid therapy) – Prednisolone in tapering doses for 8 weeks. -
Undergo evaluation after 2 months: -
If not fully recovered, receive Methotrexate + Folic acid for another 8 weeks. -
If still no improvement, switch to the alternate treatment or undergo surgery if required. -
Attend regular follow-ups for 6 months for clinical assessment and monitoring of side effects. This 2-year study aims to develop a standardized, step-by-step treatment protocol for GLM, helping improve outcomes and reduce unnecessary surgeries for affected women. |