Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti (NCT07512648) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti
China210 participantsStarted 2026-03-20
Plain-language summary
To evaluate the efficacy and safety of Sanyong Jiedu Granules in treating non-lactational mastitis with lump formation, and to investigate the relationship between its clinical efficacy and treatment duration.
Who can participate
Age range20 Years – 50 Years
SexFEMALE
See this in plain English?
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Inclusion Criteria:
* Women aged 20-50 years (inclusive) who are not in lactation or pregnancy (as confirmed
* Meeting the diagnostic criteria for non-lactational mastitis
* In the mass phase of non-lactational mastitis, with no surface ulceration or only minor ulceration or microabscesses, but without sinus tract or fistula formation
* Diagnosed as "exuberant heat-toxin syndrome" in Traditional Chinese Medicine (TCM) syndrome differentiation
* nformed consent obtained and signed by the subject
Exclusion Criteria:
* Patients with intolerance or poor compliance to the investigational drug, or known hypersensitivity to any component of this regimen
* Patients with clinically or laboratory-confirmed severe cardiac, hepatic, or renal dysfunction, or those with severe complications, active infections, persistent fever, severe bleeding tendency, or hematopoietic abnormalities
* Patients diagnosed with breast cancer by pathological biopsy
* Confirmed as tuberculous granuloma by pathogen examination
* Pregnant and lactating women, as well as women of childbearing age who are fertile but unwilling to use effective contraception throughout the trial period
* A clear history of neurological or psychiatric disorders, including epilepsy or dementia;Suspected or confirmed history of alcohol or drug abuse;Participants deemed unsuitable for the study by the investigators
What they're measuring
1
Overall Response Rate
Timeframe: 4 weeks after taking the medication, 8 weeks after taking the medication