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

Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastitis: A Prospective Multicentre Randomised Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Granulomatous Lobular Mastitis; Plasmacytic Mastitis
• Intervention / Treatment: Drug: Standard Medication; Drug: Sanyong Jiedu Granules

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoyu Gao; Phone Number: 18940250811; Email: gaoxiaoyu@sj-hospital.org

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110022
      • Shengjing Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 20-50 years (inclusive) who are not in lactation or pregnancy (as confirmed
• Meeting the diagnostic criteria for non-lactational mastitis
• In the mass phase of non-lactational mastitis, with no surface ulceration or only minor ulceration or microabscesses, but without sinus tract or fistula formation
• Diagnosed as "exuberant heat-toxin syndrome" in Traditional Chinese Medicine (TCM) syndrome differentiation
• nformed consent obtained and signed by the subject

Exclusion Criteria:

• Patients with intolerance or poor compliance to the investigational drug, or known hypersensitivity to any component of this regimen
• Patients with clinically or laboratory-confirmed severe cardiac, hepatic, or renal dysfunction, or those with severe complications, active infections, persistent fever, severe bleeding tendency, or hematopoietic abnormalities
• Patients diagnosed with breast cancer by pathological biopsy
• Confirmed as tuberculous granuloma by pathogen examination
• Pregnant and lactating women, as well as women of childbearing age who are fertile but unwilling to use effective contraception throughout the trial period
• A clear history of neurological or psychiatric disorders, including epilepsy or dementia;Suspected or confirmed history of alcohol or drug abuse;Participants deemed unsuitable for the study by the investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Standard Medication	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.
Experimental: Experimental Group 1; Sanyong Jiedu Granules	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.
Experimental: Experimental Group 2; Combination of Sanyong Jiedu Granules with Standard Medication	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate	(Complete Response + Partial Response)/Total number of cases × 100%	4 weeks after taking the medication, 8 weeks after taking the medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4 weeks after drug administration and 8 weeks after drug administration
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.	Baseline,2, 4, and 8 weeks post-treatment, and 1 and 3 months after discontinuation of medication
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).	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	The assessment is conducted by the investigator during the visit based on the results of imaging examinations and clinical examinations.	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	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation indicators	Refer to the NCI-CTCAE 5.0 classification criteria for adverse drug events.	From the first day of medication administration to 3 months after discontinuation (D140±10 days),monitor continuously.
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.	Baseline and taking Sanyong Jiedu Granules for 56 days or the time of symptoms are completely relieved or stabilized

Collaborators and Investigators

• Sponsor: Caigang Liu

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2026
• Primary Completion (Estimated): April 29, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MUKDEN-TCM-SYJD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No