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

Lead sponsor

Caigang Liu is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Study arms

• Active comparator
  Control Group

  Standard Medication

  Drug: Standard Medication

• Experimental
  Experimental Group 1

  Sanyong Jiedu Granules

  Drug: Sanyong Jiedu Granules

• Experimental
  Experimental Group 2

  Combination of Sanyong Jiedu Granules with Standard Medication

  Drug: Sanyong Jiedu Granules · Drug: Standard Medication

Interventions

• DrugSanyong 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.

• DrugStandard 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.

Primary outcomes

1. Overall Response Rate

   (Complete Response + Partial Response)/Total number of cases × 100%

   Time frame: 4 weeks after taking the medication, 8 weeks after taking the medication

Secondary outcomes

1. Lump Size

   The maximum diameter (longitudinal diameter) of the target lesion is measured by the investigator through imaging examinations (with breast ultrasound as the preferred method). If multiple lesions are present, one largest lesion is selected as the target lesion for tracking.Evaluate the percentage change in the maximum diameter of the target lesion relative to baseline at 4 weeks and 8 weeks post-treatment.

   Time frame: Baseline, 4 weeks after drug administration and 8 weeks after drug administration

2. NRS Score

   A 0-10 point numerical rating scale (NRS) was used, where 0 points indicated "no pain" and 10 points indicated "the most severe imaginable pain." Investigators guided patients to rate their pain intensity based on the average pain level over the past 24 hours during the visit.The relative changes in NRS scores from baseline were evaluated at 2, 4, and 8 weeks post-treatment and at 1 and 3 months after discontinuation of medication.

   Time frame: Baseline,2, 4, and 8 weeks post-treatment, and 1 and 3 months after discontinuation of medication

3. Course of the disease

   Imaging complete response: Imaging evaluation demonstrates complete resolution of all target lesions; Clinical response: The mass persists without clinical symptoms such as redness, swelling, heat, or pain. Imaging assessment: Breast ultrasound examinations were performed at baseline, 4 weeks after medication initiation (D28±5 days), and at treatment completion (D56/withdrawal ±7 days). Investigators assessed the size of target lesions based on ultrasound findings during follow-up visits. Clinical examination: Record the maximum diameter of the mass (unit: cm), tenderness level (using the NRS scoring system), and severity of clinical symptoms (cutaneous erythema, tissue swelling, and localized heat sensation) at 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).

   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)

4. Recurrence Rate

   The assessment is conducted by the investigator during the visit based on the results of imaging examinations and clinical examinations.

   Time frame: Recurrence of disease activity within three months of the end of treatment

5. The total dose of steroid hormones or antibiotics from the initiation to the completion of treatment

   Administration of steroid hormone medications : Record the specific dosage, route of administration, and duration of treatment for each patient per administration. For glucocorticoids, calculate the equivalent total dose of prednisone concurrently. Administration of antibiotics: Record the specific dosage, route of administration, and duration of medication for each patient per administration.

   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)

Other outcomes

1. Safety evaluation indicators

   Refer to the NCI-CTCAE 5.0 classification criteria for adverse drug events.

   Time frame: From the first day of medication administration to 3 months after discontinuation (D140±10 days),monitor continuously.

2. Exploratory indicators

   Breast lesion tissues (matched pathological tissue samples from pre-enrollment puncture biopsy and post-treatment lesion resection), blood samples collected 56 days after administration of San Yong Jie Du Granules or until complete symptom relief/stabilization, compared with baseline levels: detection of serum T-cell subsets (CD4+, CD8+), serum antibodies (IgG, IgA), and measurement of inflammatory cytokine expression including IL-6, IL-1β, NF-κB, and TNF-α.

   Time frame: Baseline and taking Sanyong Jiedu Granules for 56 days or the time of symptoms are completely relieved or stabilized

Individual participant data

Plan to share: No