Idiopathic Granulomatous MastitisIIGMNCT04096300
An Integrative Approach for Idiopathic Granulomatous Mastitis.
An observational study of Idiopathic Granulomatous Mastitis, run by Medipol University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Idiopathic Granulomatous Mastitis
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Adult
Study population: Patients receiving Traditional and Complementary Medicine (T\&CM) for IGM will be retrospectively analyzed.
Who may be able to join
- 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
Who cannot join
- Patients currently using any conventional treatment, and/or contraindication to hirudotherapy and cupping.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Idiopathic Granulomatous Mastitis
- Keywords
- Integrative Medicine, Ethnomedicine, Hirudotherapy, Idiopathic Granulomatous Mastitis, Medical Cupping Therapy, Traditional and Complementary Medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Breast Mass Size
Ultrasonic scan at 6 months
Measured: Up to 12 months
Change of Breast Mass Size
Ultrasonic scan at 12 months
Measured: Up to 48 months
Secondary outcomes (1)
Change of Breast Mass Size
MRI scan at 12 months, if prompted by ultrasonic scan
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Jun 2019
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Granulomatous MastitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujgan Calişkan, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096300
- Sponsor's protocol ID
- IMUEC396
- Acronym
- IIGM
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional and Complementary Medicine: a Cure for Idiopathic Granulomatous Mastitis?
- ClinicalTrials.gov ID
- NCT04096300
- Acronym / sponsor ID
- IIGM / IMUEC396
- Conditions
- Idiopathic Granulomatous Mastitis
- Keywords
- Integrative Medicine, Ethnomedicine, Hirudotherapy, Idiopathic Granulomatous Mastitis, Medical Cupping Therapy, Traditional and Complementary Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients receiving Traditional and Complementary Medicine (T\&CM) for IGM will be retrospectively analyzed.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients currently using any conventional treatment, and/or contraindication to hirudotherapy and cupping.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Breast Mass Size
Time frame: Up to 12 months
Ultrasonic scan at 6 months
Change of Breast Mass Size
Time frame: Up to 48 months
Ultrasonic scan at 12 months
1 secondary outcome
Change of Breast Mass Size
Time frame: Up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Granulomatous Mastitis, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Breast Mass Size (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.