Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti
Starting soon · Not applicable
Conditions studied: Plasmacytic Mastitis, Granulomatous Lobular Mastitis
In brief
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.
Key facts
- Study ID
- NCT07512648
- Run by
- Caigang Liu
- People needed
- 210
- Starts
- 2026-03-20
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-04-06
Who can join
Age: 20 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
Full record on ClinicalTrials.gov
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