Comparison of effect of simultaneous oral colchicine and intralesional corticosteroid injection versus oral colchicine and topical triamcinolone in patients with idiopathic granulomatous mastitis

Comparison of the treatment responses to simultaneous oral colchicine and intralesional corticosteroid injection versus oral colchicine and topical triamcinolone in patients with idiopathic granulomatous mastitis referred to the IGM clinic: a randomized clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100706004329N13

Enrollment

Registered

2025-08-10

Start date

2025-05-31

Completion date

Unknown

Last updated

2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic granulomatous mastitis. Inflammatory disorders of breast

Interventions

Intervention 1: Intervention Group A: The group receiving oral colchicine at a dose of 1 mg every 12 hours and intralesional triamcinolone injection. Intervention 2: Intervention Group B: The group re

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: female patients who presented with breast mass to IGM clinic biopsy proven IGM

Exclusion criteria

Exclusion criteria: Patients who are unwilling to cooperate. Pregnancy breastfeeding History of breast cancer in the last two years. Contraindications for colchicine, including: renal/hepatic/cardiac failure, history of drug allergy. Contraindications for triamcinolone: history of drug allergy, hepatic failure.

Design outcomes

Primary

Measure	Time frame
Severity of IGM in physical exam. Timepoint: Every 3-4 weeks visit. Method of measurement: IGM patients examination form.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrnoosh Kialashaky

Tehran University of Medical Sciences

m.kialashaky@gmail.com+98 21 6119 2761

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026