NCT04096300

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

September 16, 2019

Last Update Submit

September 18, 2019

Conditions

Idiopathic Granulomatous Mastitis

Keywords

Integrative MedicineEthnomedicineHirudotherapyIdiopathic Granulomatous MastitisMedical Cupping TherapyTraditional and Complementary Medicine

Outcome Measures

Primary Outcomes (2)

  • Change of Breast Mass Size

    Ultrasonic scan at 6 months

    Up to 12 months

  • Change of Breast Mass Size

    Ultrasonic scan at 12 months

    Up to 48 months

Secondary Outcomes (1)

  • Change of Breast Mass Size

    Up to 48 months

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Beykoz, Istanbul, 34810, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy Samples

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 19, 2019

Study Start

June 1, 2019

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

TU(1)