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Efficacy of Ruyong formula combined with antibiotics in the treatment of early Infectious lactational mastitis: a prospective randomized, double-blind, placebo-controlled study

Efficacy of Ruyong formula combined with antibiotics in the treatment of early Infectious lactational mastitis: a prospective randomized, double-blind, placebo-controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063715
Enrollment
Unknown
Registered
2022-09-15
Start date
2022-09-15
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Infectious Lactational Mastitis

Interventions

Group 1 :Ruyong Formula and antibiotics
Group 2:placebo and antibiotics

Sponsors

Shanghai Fourth People's Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. From November 2021 to November 2023, patients who visited the breast department of Shanghai Fourth People's Hospital Affiliated to Tongji University; 2. Meet the diagnostic criteria for the early stage of infectious lactation mastitis; 3. Lactating women aged 18-50 years; 4. Subjects with informed consent, voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Breast abscess formation; 2. Breast Raynaud's disease; 3. Other breast pathological diseases; 4. Combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, mental illness; abnormal renal function; ALT, AST > 1.5 times the upper limit of the normal reference value; 5. Those who are known to be allergic to the ingredients of this drug; 6. History of antibiotic application within 2 weeks.

Design outcomes

Primary

MeasureTime frame
effective rate;

Secondary

MeasureTime frame
Cure time;Recurrence rate;Microflora determination in milk;Vital signs;Laboratory tests;Breast sonography;

Countries

China

Contacts

Public ContactYingna Tao

Shanghai Fourth People's Hospital Affiliated to Tongji University

TerainaTao@126.com+86 13917486396

Outcome results

None listed

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