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

This study is a randomised controlled trial comprising three phases: the screening phase, the treatment phase and the follow-up phase.

1. Screening phase: A total of 210 patients with mastitis who were not breastfeeding and met the inclusion and exclusion criteria were enrolled in either the experimental group or the control group, with 70 patients in each of Experimental Group 1, Experimental Group 2 and the control group. 2. Treatment phase:

Experimental Group 1: San Yong Jie Du Granules group: San Yong Jie Du Granules were taken with boiled water, 10 g per dose, three times daily, for 56 consecutive days or until symptoms were completely resolved or stabilised;

Experimental Group 2: San Yong Jie Du Granules + guideline-based medication group:

Treatment regimen for plasma cell mastitis:

Patients without cephalosporin allergy: Oral cefuroxime axetil tablets (brand name: Dalixin®), 250 mg twice daily + oral metronidazole tablets, 0.4 g three times daily, for 7-10 consecutive days; In addition, take San Yong Jie Du Granules, 10g three times daily, for 56 consecutive days or until symptoms have completely resolved or stabilised; For patients allergic to cephalosporins: Oral levofloxacin tablets, 0.5g once daily + oral metronidazole tablets, 0.4g three times daily, for 7-14 consecutive days; In addition, take San Yong Jie Du Granules three times daily, 10g per dose, for 5-6 days or until symptoms have completely resolved or stabilised;

Treatment regimen for granulomatous lobular mastitis:

Take oral methylprednisolone tablets (brand name: Metrol®), 20 mg once daily, for 14 consecutive days. Once symptoms have subsided, gradually reduce the dose every 1-2 weeks to 16, 12, 8, and 4 mg/day; In addition, take San Yong Jie Du Granules, 10 g three times daily, for 56 consecutive days or until symptoms have completely resolved or stabilised;

Control group: Standard guideline treatment group, i.e. treatment is based on the 2016 'Expert Consensus on the Diagnosis and Treatment of Non-lactational Mastitis' issued by the Breast Health and Breast Disease Prevention and Control Working Group of the Women's Health Branch of the Chinese Preventive Medicine Association. The two main types of non-lactational mastitis-plasma cell mastitis and granulomatous lobular mastitis-are treated in accordance with the expert consensus respectively.

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.

Prior to the completion of the primary efficacy endpoint assessment (i.e. before week 8 of treatment), no destructive surgical procedures aimed at lesion clearance are permitted in any group, except in cases meeting the criteria for initiation of salvage therapy. 3. Follow-up points and time windows: 2 weeks (±1 day) after commencement of medication, 4 weeks (±2 days) after commencement of medication, and upon completion of treatment/discontinuation of medication (±4 days). 4. Follow-up period: Follow-up points and time windows: 4 weeks (±7 days) after discontinuation of treatment, 3 months (±7 days) after discontinuation of treatment.

• Lump Size [Time frame: Baseline, 4 weeks after drug administration and 8 weeks after drug administration]
• NRS Score [Time frame: Baseline,2, 4, and 8 weeks post-treatment, and 1 and 3 months after discontinuation of medication]
• Course of the disease [Time frame: Baseline, 2 weeks after medication initiation (D14±3 days), 4 weeks after medication initiation (D28±5 days), and at treatment completion (D56/withdrawal ±7 days)]
• Recurrence Rate [Time frame: Recurrence of disease activity within three months of the end of treatment]
• The total dose of steroid hormones or antibiotics from the initiation to the completion of treatment [Time frame: The calculation begins on the day of randomization for the subjects (denoted as Day 0) and continues until the completion of treatment (Day 56/withdrawal)]