Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorCaigang Liu
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sanyong Jiedu Granules
- Standard Medication
Treatment groups
210 Participants
are divided into 3 treatment groupsSponsors and collaborators
Caigang Liu
Lead sponsor
Shengjing Hospital
Sponsor institution
Source ClinicalTrials.gov