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Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti
Sponsor: Caigang Liu
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.
Official title: Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastitis: A Prospective Multicentre Randomised Controlled Trial
Key Details
Gender
FEMALE
Age Range
20 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2026-03-20
Completion Date
2028-07-31
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China