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Danlu Capsule in the treatment of mammary gland hyperplasia (imbalance of charge and discharge, stagnation and phlegm syndrome) multi-center, open, single-arm phase IV clinical trial

Danlu Capsule in the treatment of mammary gland hyperplasia (imbalance of charge and discharge, stagnation and phlegm syndrome) multi-center, open, single-arm phase IV clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2000003543
Enrollment
Unknown
Registered
2020-08-04
Start date
2018-05-10
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Hyperplasia of mammary gland (imbalance of charge and discharge, stagnation and phlegm syndrome)

Interventions

Sponsors

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of mammary gland hyperplasia in western medicine; (2) Meet the standard of TCM syndrome differentiation of imbalance of charge and discharge,stagnation and phlegm syndrome; (3) At least 18 years old; (4) Informed consent, volunteer and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) In gestation period , suckling period, serious menstrual disorder, functional uterine bleeding women;) (2) Patients with breast inflammation, breast malignant tumor and simple benign tumor; (3) Prophylactic and sex hormone user; (4) Serious heart, liver, kidney disease or hematopoietic system disease, mental patient; (5) Allergic constitution or allergic to the ingredients of the medicine used in this trial; (6) Having a pregnancy plan within 3 months; (7) Participated in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
Breast tumor size;Routine blood test;Breast pain;Urine routine test;

Secondary

MeasureTime frame
TCM Comprehensive Treatment;TCM syndromes score;

Countries

China

Contacts

Public ContactXiaojun Zhang

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

zxj6298@sohu.com+86 13801081032

Outcome results

None listed

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