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A Single-Arm, Prospective, Interventional Clinical Study of Qingchang Tongru Formula for the Treatment of Non-Abscess Type Lactation Mastitis

A Single-Arm, Prospective, Interventional Clinical Study of Qingchang Tongru Formula for the Treatment of Non-Abscess Type Lactation Mastitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000698
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Non-abscess lactational mastitis

Interventions

Experimental Group:Oral QingchangTongru Formula for one week.

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old; (2) Confirmed as having acute mastitis in the lactation period at the initial stage (Western medicine: milk stasis or acute inflammatory type; Traditional Chinese medicine: Liver and Stomach with or Qi and Blood stagnation syndrome, but the breast has not yet formed pus), and with palpable breast masses; (3) Intend to continue breastfeeding; (4) Willing to participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) The formation of a breast abscess or its rupture and pus discharge; (2) Concurrent breast cancer; (3) No intention to breastfeed; (4) Presence of chronic infectious diseases requiring antibiotic treatment; (5) Accompanied by severe organic functional impairments of the heart, liver, kidneys, or mental illnesses; (6) Use of antibiotics, probiotics, etc., within 1 week prior to enrollment or during the study period.

Design outcomes

Primary

MeasureTime frame
Day 7 Significant Reduction Rate;

Secondary

MeasureTime frame
Day-7 Complete Erosion Rate;Purulent rate;Inflammatory markers;Sentiment Index;Non-abscess lactation mastitis symptom scoring;Adverse Reaction;

Countries

China

Contacts

Public ContactXiufei Gao

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

gaoxiufei@zcmu.edu.cn13868186611

Outcome results

None listed

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