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NCT05395949: GLMwPD
A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders
NA trial testing conservative treatment in Breast Diseases in 50 participants. Enrolling by invitation.
30 December 2022
Quick facts
| Lead sponsor | Wuhan University |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 January 2019 |
| Primary completion | 30 December 2022 |
| Estimated completion | 30 January 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- conservative treatment — full drug profile →
Conditions studied
- Breast Diseases — all drugs for Breast Diseases →
- Mastitis Granulomatous — all drugs for Mastitis Granulomatous →
- Psychiatric Disorder — all drugs for Psychiatric Disorder →
Sponsor
Wuhan University
Who can join
Adults 18 to 60, female only, with Breast Diseases or Mastitis Granulomatous. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 .
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05395949
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05395949 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wuhan University
- Last refreshed: 27 May 2022
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