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Clinical Trial of Shaogan San Yong Formula for Acute Suppurative Mastitis: Efficacy and Multi-Omics Mechanisms

Clinical efficacy and safety assessment of Shaogansanyongfang in the treatment of acute mastitis in the acute inflammatory stage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001486
Enrollment
Unknown
Registered
2025-07-26
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute mastitis

Interventions

Experimental group:SGSY granule administered orally twice a day
Control Group:SGSY placebo orally twice a day

Sponsors

The third Hospital affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Meets diagnostic criteria for lactational mastitis. (Guidelines for the diagnosis and management of chronic obstructive pulmonary disease (revised 2021 version) (2) Course = 72 hours no abscess detected on ultrasonography. (3)=4 point according to Visual Analogue Seal (VAS) (4) Fever higher than 37.2? PT(Peak Temperature) 12×109/L (6) Voluntary written informed consent obtained.

Exclusion criteria

Exclusion criteria: (1) Excludes other breast or metabolic disorders that contraindicate breastfeeding. (2) Treated with pharmacotherapy for the current episode of acute suppurative mastitis. (3) History of cephalosporin allergy and antibiotic abuse. (4) Patients with severe heart liver or kidney diseases (laboratory values exceeding the normal range by more than twofold). (5) Patients with comorbid psychiatric disorders epilepsy cognitive impairments or other major illnesses. (6) Patients with other infectious diseases undergoing treatment with traditional Chinese medicine or antibiotics. (7) Pregnant during lactation. (8) Participating in other clinical studies. (9) Patients considered by the investigator to be unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
Dyspepsia VAS;Body Temperature;

Secondary

MeasureTime frame
Recovery rate;TCM patterns(Traditional Chinese Medicine pattern);Laboratory tests;Recurrence rate;Breast mass area;Engorgement and Skin Erythema Score;

Countries

China

Contacts

Public ContactYingyi Fan

The Third Affiliated Hospital of Beijing University of Chinese Medicine

fan38898901@126.com15810964868

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026