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Clinical effect of Yiqi Heying Decoction on granulomatous lobular mastitis

Clinical effect of Yiqi Heying Decoction on granulomatous lobular mastitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000477
Enrollment
Unknown
Registered
2025-03-06
Start date
2024-06-25
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granulomatous Lobular Mastitis

Interventions

control group:Hormone combined with antibiotic therapy + basic therapy
Test group:Oral Yiqi and Ying Chinese medicine treatment + basic treatment

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Non-pregnant lactating female patients 2. It meets the criteria for the pathologic diagnosis of granulomatous mastitis the criteria for breast ultrasound sonography and the diagnostic criteria for Chinese medicine; 3. Those who accepted and cooperated with conservative treatment alone and completed the research study; 4. Those without severe organic diseases immune-related and psycho-spiritual disorders; 5. Volunteer to participate in the trial and sign the informed consent form .

Exclusion criteria

Exclusion criteria: 1. Patients with unclear pathologic diagnosis 2. Patients with acute infections or those already on antibiotics 3. Patients with tuberculosis-infected T cells (ESAT-6 CFP-10) PDD tuberculin test suspecting breast tuberculosis 4. Those who are unable to take herbs or hormones due to physical or other reasons 5. Patients with a combination of other immune-related diseases 6. Persons with a combination of serious primary diseases of the cardiovascular cerebrovascular renal hepatic endocrine and hematopoietic systems persons with mental illnesses or persons with mental or legal disabilities 7. Other pathologies that in the judgment of the investigator reduce the likelihood of enrollment or complicate enrollment such as conditions that predispose to loss of visitation such as frequent changes in the work environment and those who are unable to give full informed consent due to mental and behavioral disorders 8. Patients already enrolled in other ongoing clinical research trials

Design outcomes

Primary

MeasureTime frame
Breast pain (VAS score);Size, hardness and distribution of breast mass;TCM syndrome integral;Degree of nipple discharge;

Secondary

MeasureTime frame
Breast gland thickness and breast duct diameter;Serum sex hormone levels in breast color ultrasound;Quality of life;

Countries

China

Contacts

Public ContactLiu Xiaofei

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

drliuxf@126.com15615611377

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026