ClinicalTrials.gg
Status unknownNCT04096300IIGMUpdated Sep 19, 2019

An Integrative Approach for Idiopathic Granulomatous Mastitis.

An observational study in Idiopathic Granulomatous Mastitis, sponsored by Medipol University. Status unknown at 1 site in Turkey. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-09-19.

Sponsored by Medipol University · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
30
Ages
25 Years to 45 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Idiopathic Granulomatous Mastitis

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Keywords

  • Integrative Medicine
  • Ethnomedicine
  • Hirudotherapy
  • Idiopathic Granulomatous Mastitis
  • Medical Cupping Therapy
  • Traditional and Complementary Medicine
03

In context

Granulomatous Mastitis

22 studies on the registry are indexed under Granulomatous Mastitis; 7 are open to participants now.

This study's enrollment of 30 is below the median of 79 across 10 observational studies indexed under Granulomatous Mastitis.

Browse Granulomatous Mastitis studies →

Lead sponsor

Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Patients receiving Traditional and Complementary Medicine (T\&CM) for IGM will be retrospectively analyzed.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients currently using any conventional treatment, and/or to hirudotherapy and cupping.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
30 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Change of Breast Mass Size

    Ultrasonic scan at 6 months

    Time frame: Up to 12 months

  2. Change of Breast Mass Size

    Ultrasonic scan at 12 months

    Time frame: Up to 48 months

Secondary outcomes

  1. Change of Breast Mass Size

    MRI scan at 12 months, if prompted by ultrasonic scan

    Time frame: Up to 48 months

07

Study locations

1 site
  • Medipol University
    Beykoz, Istanbul 34810, Turkey
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2019 (actual). Primary completion is estimated for Sep 2019, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2019
First posted
Sep 19, 2019
StartActual
Jun 1, 2019
Primary completionEst.
Sep 2019
CompletionEst.
Sep 2019
Last update
Sep 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04096300
Lead sponsor
Medipol University
Responsible party
Mujgan Calişkan (Professor, Medipol University) — Principal investigator
First posted
Sep 19, 2019
Start date
Jun 1, 2019
Primary completion
Sep 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Sep 19, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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