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A Clinical Study on the Efficacy of Sanhuang Powder Combined with Low-Frequency Pulsed Electrical Stimulation in the Treatment of Acute Puerperal Mastitis

A Clinical Study on the Efficacy of Sanhuang Powder Combined with Low-Frequency Pulsed Electrical Stimulation in the Treatment of Acute Puerperal Mastitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001101
Enrollment
Unknown
Registered
2026-04-28
Start date
2023-12-02
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Acute Mastitis

Interventions

Standard Group:Routine Clinical Treatment
Combined Group:Routine Clinical Treatment + Sanhuang Powder + Low-Frequency Pulsed Electrical Stimulation

Sponsors

Xinxiang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Meeting the Western medicine diagnostic criteria for acute puerperal mastitis (referencing Practical Obstetrics and Gynecology): being in the puerperal period, presenting with fever, headache, general malaise, poor appetite, and a palpable breast mass, accompanied by symptoms such as redness, swelling, heat, and pain, as well as an elevated white blood cell count. (2) Meeting the Traditional Chinese Medicine (TCM) diagnostic criteria for Ruyong (Breast Abscess) (referencing TCM Surgery): presenting with obstructed milk flow, breast lumps, distending pain within the breast, loss of appetite, chills and fever, and dry stools. (3)20 years = Age = 40 years (4) Willingness to accept the proposed treatment regimen. (5) Voluntary participation in the study and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Individuals with an allergic constitution, or those with a known allergy to the components of Sanhuang Power (Scutellaria, Phellodendron, and Rhubarb) or to cephalosporin antibiotics. (2) Individuals with co-morbid breast diseases (e.g., breast tumors, breast tuberculosis, breast fibroadenoma, etc.). (3) Individuals suffering from mental or psychological disorders that preclude normal communication and cooperation with the treatment. (4) Individuals currently participating in other clinical studies or receiving other treatment regimens. (5) Individuals with poor compliance who, in the investigator's judgment, are unable to complete the proposed treatment regimen. (6) Individuals who, during pregnancy or lactation, suffer from severe internal medical conditions other than puerperal mastitis.

Design outcomes

Primary

MeasureTime frame
Overall Clinical Efficacy Rate;

Secondary

MeasureTime frame
TCM Symptom Scoring;Inflammatory Marker Levels;Pain Intensity;Treatment Satisfaction Rate;Incidence of Adverse Reactions;

Countries

China

Contacts

Public ContactLiang Yan

Xinxiang Central Hospital

mianmian4037@126.com16637352697

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026