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An Integrative Approach for Idiopathic Granulomatous Mastitis. (IIGM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096300
Recruitment Status : Active, not recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mujgan Calişkan, Medipol University

Brief 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.


Condition or disease
Idiopathic Granulomatous Mastitis

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Traditional and Complementary Medicine: a Cure for Idiopathic Granulomatous Mastitis?
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases




Primary Outcome Measures :
  1. Change of Breast Mass Size [ Time Frame: Up to 12 months ]
    Ultrasonic scan at 6 months

  2. Change of Breast Mass Size [ Time Frame: Up to 48 months ]
    Ultrasonic scan at 12 months


Secondary Outcome Measures :
  1. Change of Breast Mass Size [ Time Frame: Up to 48 months ]
    MRI scan at 12 months, if prompted by ultrasonic scan


Biospecimen Retention:   Samples Without DNA
Biopsy Samples


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving Traditional and Complementary Medicine (T&CM) for IGM will be retrospectively analyzed.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096300


Locations
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Turkey
Medipol University
Beykoz, Istanbul, Turkey, 34810
Sponsors and Collaborators
Medipol University
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Responsible Party: Mujgan Calişkan, Professor, Medipol University
ClinicalTrials.gov Identifier: NCT04096300    
Other Study ID Numbers: IMUEC396
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mujgan Calişkan, Medipol University:
Integrative Medicine
Ethnomedicine
Hirudotherapy
Idiopathic Granulomatous Mastitis
Medical Cupping Therapy
Traditional and Complementary Medicine
Additional relevant MeSH terms:
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Mastitis
Granulomatous Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases