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Effect of Cinnora in treatment of idiopathic granulomatous mastitis resistance to Prednisolone

Comparing the effects of Cinnora and Methotrexate in treating patients with idiopathic granulomatous mastitis resistance to Prednisolone

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211018052807N1
Enrollment
40
Registered
2021-11-08
Start date
2021-11-06
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Idiopathic granulomatous mastitis. Granulomatous disorder of the skin and subcutaneous tissue, unspecified

Interventions

Intervention 1: Intervention group: Patients who did not respond well to prednisolone (20 to 30 mg) treated with cinnora (Cinnagen Company) 40 mg every two weeks subcutaneously with prednisolone in th

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with granulomatous mastitis in breast mass pathology in whom the known causes of granulomatous mastitis have been ruled out Resistance to prednisolone treatment with a dose of 20 to 30 for 3 months Hepatitis B, hepatitis C and TB negative

Exclusion criteria

Exclusion criteria: Patients with infectious mastitis or positive bacterial culture Patients with granulomatous mastitis with caseous necrosis Patients with culture or PCR positive for TB People with breast cancer Patients with hepatitis B or hepatitis C positive

Design outcomes

Primary

MeasureTime frame
Response to treatment. Timepoint: monthly. Method of measurement: Lack of response is considered if the clinical and paraclinical symptoms improve by less than 25% , in case of improvement 25 to 75% relative response and in case of improvement above 75%, the answer is considered complete.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMona Ziaei

Kashan University of Medical Sciences

ziaei.mona.87@gmail.com+98 21 2204 2682

Outcome results

None listed

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