An Integrative Approach for Idiopathic Granulomatous Mastitis. (IIGM)

September 18, 2019 updated by: Mujgan Calişkan, Medipol University

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Istanbul
      • Beykoz, Istanbul, Turkey, 34810
        • Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 43 years (Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Breast Mass Size
Time Frame: Up to 12 months
Ultrasonic scan at 6 months
Up to 12 months
Change of Breast Mass Size
Time Frame: Up to 48 months
Ultrasonic scan at 12 months
Up to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Breast Mass Size
Time Frame: Up to 48 months
MRI scan at 12 months, if prompted by ultrasonic scan
Up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMUEC396

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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