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Qingre Jiedu Decoction treatment Clinical study protocol for observation of efficacy in the acute phase of cystic neutrophilic granulomatous mastitis

Qingre Jiedu Decoction treatment Clinical study protocol for observation of efficacy in the acute phase of cystic neutrophilic granulomatous mastitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068824
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

cystic neutrophilic granulomatous mastitis

Interventions

Qingre Jiedu Decoction group:Oral Qingre Jiedu Decoction

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1)Meet the diagnostic criteria for cystic neutrophilic granulomatous mastitis; (2)Meet the diagnostic criteria in the acute phase (TCM differentiation belongs to the evidence of liver meridian heat); (3)Women aged between 18~60 (including 18 and 60 years old); (4)Informed consent, who can cooperate with treatment and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Patients with malignant breast tumors. (2)Those who are allergic to drugs known in the prescription; (3)Patients with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney, hematopoietic system, or psychosis; (4)Women who are pregnant and lactating; (5)Those who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The rate of reduction of breast redness and swelling;The rate of reduction of breast mass area;

Secondary

MeasureTime frame
A VAS score for breast pain;Local skin changes;Changes in systemic symptoms;Ultrasonic examination;Complete blood count;C-reactive protein;erythrocyte sedimentation Rate;TCM symptom score;

Countries

China

Contacts

Public ContactZhang Dongxiao

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

morningdong@163.com+86 138 1107 7684

Outcome results

None listed

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