drugset / Trial / NCT05395949

A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders

NCT05395949

Enrolling by invitation 50 enrolled Wuhan University
RandomizedParallel-groupSingle-blindTreatment

Summary

Granulomatous lobular mastitis (GLM) is a relatively rare chronic inflammatory disease of the breast in clinical practice. A small number of patients develop hyperprolactinemia during psychiatric drug treatment, and most of these patients are nulliparous. At present, there is no unified treatment mode at home and abroad, and surgery is generally the main treatment. GLM is a sterile inflammation, and glucocorticoids and methotrexate can effectively relieve clinical symptoms and even reach the standard of cure. In order to reduce the recurrence rate and protect the breast appearance as much as possible, we propose a conservative therapy. The purpose of this study was to compare this conservative therapy of granulomatous lobular mastitis with existing surgical treatment, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients with psychiatric disorders .

Timeline

Start
2019-01-01
Primary completion
2022-12-30
Completion
2027-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MTX Unknown 7.5 mg
Subject Prednisone Other / unclassified 10 mg
Background Calcium carbonate Other / unclassified
Background Omeprazole Other / unclassified