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Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti

NCT07512648 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Plasmacytic Mastitis
  • Granulomatous Lobular Mastitis

Interventions

DRUG

Sanyong Jiedu Granules

Prescribe Sanyong Jiedu Granules, to be taken with hot water, 10 g per dose, three times daily, for a course of 56 days or until symptoms have completely resolved or stabilised.

DRUG

Standard Medication

Treatment regimen for plasma cell mastitis: For patients without cephalosporin allergy: oral cefuroxime axetil tablets (brand name: Dalixin®), 250 mg twice daily, plus oral metronidazole tablets, 0.4 g three times daily, for 7-10 consecutive days. For patients allergic to cephalosporins: oral levofloxacin tablets, 0.5 g once daily, plus oral metronidazole tablets, 0.4 g three times daily, for 7-14 consecutive days. Treatment regimen for granulomatous lobular mastitis: Oral methylprednisolone tablets (brand name: Metrol®), 20 mg once daily for 14 consecutive days; following symptom relief, the dose should be gradually reduced every 1-2 weeks to 16, 12, 8, and 4 mg/day, and continued for 56 days or until symptoms are completely resolved or stabilised.

Sponsors & Collaborators

  • Caigang Liu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2028-04-29
Completion
2028-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512648 on ClinicalTrials.gov