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NOT YET RECRUITING
NCT07512648
NA

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

Sponsor: Caigang Liu

View on ClinicalTrials.gov

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

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.

Locations (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China