Real world clinical study of IPRM in the treatment of Acne Mastitis with retention of toxins syndrome type

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ITMCTR

Registry ID

ITMCTR2000003613

Enrollment

Unknown

Registered

2020-08-21

Start date

2020-10-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Acne Mastitis

Interventions

1:external treatment of TCM

1:surgery of incise and plastic repair method

1:herbal oral administration

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Accord with the diagnosis standard of Acne Mastitis (non-lactation mastitis). 2) According to the diagnostic criteria of retention of toxins syndrome type. 3) Female aged from 20 to 55 years old. 4) The lesion area involved nipple and Areola and <= 1 quadrant of breast. 5) Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with serious primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, which affect their survival. 2) The patient with severe infection and serious condition. 3) The lesion does not involve the nipple and Areola or is more than 1 quadrant of breast. 4) Patients who participated in other clinical trials within 1 month. 5) Patients with MRI contraindications. 6) Patients who were considered unsuitable by the researchers.

Design outcomes

Primary

Measure	Time frame
Nipple shape score;Wound healing rate;Recurrence rate;Healing time of sore surface;	—

Countries

China

Contacts

Public ContactYe Meina

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

yemeina2002@126.com+86 18930282548

Outcome results

None listed

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