UnknownPhase 2

A Single Arm Study of Traditional Chinese Medicine for Plasma Cell Mastitis

China50 participantsStarted 2021-10-01

Plain-language summary

This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis.

Age range20 Years – 60 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Meet the diagnostic criteria for plasma cell mastitis.
✓. Women aged \> 20 years and ≤ 60 years.
✓. Karnofsky Performance Status (KPS) Scale score ≥ 70.
✓. Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups.

✕. Pregnant and lactating women; fertile women who provide positive results of baseline pregnancy test; women of childbearing age who are unwilling to take effective contraceptive measures during the whole study period.
✕. Patients with serious underlying diseases, such as diabetes, cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system diseases.
✕. Allergic constitution, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of the drugs used in this trial.
✕. Recent use of antidepressants and other psychotropic drugs.
✕. Hormone and immunosuppressive therapy were used one month before enrollment.

Clinical cure rate

Timeframe: During treatment（1 month to 6 months）

Clinical response rate

Timeframe: During treatment（1 month to 6 months）

NCT IDNCT05530226

SponsorShengjing Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-31

Nan Niu, MD