An Integrative Approach for Idiopathic Granulomatous Mastitis.

Idiopathic Granulomatous Mastitis Clinical Trial

— IIGM  

Official title:

Traditional and Complementary Medicine: a Cure for Idiopathic Granulomatous Mastitis?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04096300
• Other study ID #: IMUEC396
• Status: Active, not recruiting
• Start date: June 1, 2019
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Collaboration is established between Turkish Holistic & Integrative Medicine Association and Traditional & Complementary Medicine Society of Istanbul Medipol University.

Study is carried out on idiopathic granulomatous mastitis patients who are followed in the Breast Clinic at Istanbul Medipol University Hospital for between September 2015 and September 2019. Hirudotherapy and medical cupping therapy were applied as traditional and complementary medicine integratively.

Following initial radiological imaging, microbiological- and histological testing, side effects and relapses are analyzed. Follow-up examination is also carried out at the end of the treatment, which consisted of clinical breast exam and radiological imaging.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• IGM patients, either ones newly diagnosed or had previously received different types of treatments, currently refusing conventional treatments with immunosuppressives etc, or/and surgical management, and now und

Exclusion Criteria:

• Patients currently using any conventional treatment, and/or contraindication to hirudotherapy and cupping.

Related Conditions & MeSH terms

• Granulomatous Mastitis
• Idiopathic Granulomatous Mastitis
• Mastitis

Locations

Country	Name	City	State
Turkey	Medipol University	Beykoz	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Breast Mass Size	Ultrasonic scan at 6 months	Up to 12 months
Primary	Change of Breast Mass Size	Ultrasonic scan at 12 months	Up to 48 months
Secondary	Change of Breast Mass Size	MRI scan at 12 months, if prompted by ultrasonic scan	Up to 48 months