Plasmacytic MastitisNCT07512648
Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti
A study testing Sanyong Jiedu Granules and Standard Medication in people with Plasmacytic Mastitis and Granulomatous Lobular Mastitis, run by Caigang Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Plasmacytic Mastitis, Granulomatous Lobular Mastitis
- What is being tested?
- Sanyong Jiedu Granules and Standard Medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110022
About this study
Official title: 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.
Read the detailed description
This study is a randomised controlled trial comprising three phases: the screening phase, the treatment phase and the follow-up phase.
- 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.
- 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.
- 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).
- 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.
- Being tested
- Sanyong Jiedu Granules, Standard Medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanyong Jiedu GranulesDrug
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 MedicationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard Medication Receives: Drug: Standard Medication |
| Experimental Group 1 | Experimental | Sanyong Jiedu Granules Receives: Drug: Sanyong Jiedu Granules |
| Experimental Group 2 | Experimental | Combination of Sanyong Jiedu Granules with Standard Medication Receives: Drug: Sanyong Jiedu Granules; Drug: Standard Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
(Complete Response + Partial Response)/Total number of cases × 100%
Measured: 4 weeks after taking the medication, 8 weeks after taking the medication
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start20 Mar 2026 (estimated)
- Primary completion29 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmacytic MastitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caigang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caigang Liu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512648
- Sponsor's protocol ID
- MUKDEN-TCM-SYJD01
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastitis: A Prospective Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07512648
- Acronym / sponsor ID
- MUKDEN-TCM-SYJD01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Caigang LiuUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 29 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomised controlled trial comprising three phases: the screening phase, the treatment phase and the follow-up phase.
- 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.
- 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.
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Standard MedicationStandard Medication |
| Experimental Group 1 | Experimental | Drug: Sanyong Jiedu GranulesSanyong Jiedu Granules |
| Experimental Group 2 | Experimental | Drug: Sanyong Jiedu Granules, Drug: Standard MedicationCombination of Sanyong Jiedu Granules with Standard Medication |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sanyong Jiedu GranulesPrescribe 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 | Experimental Group 1, Experimental Group 2 |
| Standard MedicationTreatment 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 | Control Group, Experimental Group 2 |
Primary outcome
Overall Response Rate
Time frame: 4 weeks after taking the medication, 8 weeks after taking the medication
(Complete Response + Partial Response)/Total number of cases × 100%
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sanyong Jiedu Granules and Standard Medication in people with Plasmacytic Mastitis and Granulomatous Lobular Mastitis, run by Caigang Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Gao (18940250811, gaoxiaoyu@sj-hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 4 weeks after taking the medication, 8 weeks after taking the medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.