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A single center and single arm exploratory clinical trial of Honghua Xiaoyao tablets in the treatment of breast hyperplasia (liver stagnation and blood stasis type)

A single center and single arm exploratory clinical trial of Honghua Xiaoyao tablets in the treatment of breast hyperplasia (liver stagnation and blood stasis type)

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000165
Enrollment
Unknown
Registered
2024-08-05
Start date
2021-11-11
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

breast hyperplasia (liver stagnation and blood stasis type)

Interventions

Case series:Honghua Xiaoyao tablets

Sponsors

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of mammary gland hyperplasia in Western medicine; (2) Meet the syndrome differentiation criteria of liver stagnation and blood stasis in traditional Chinese medicine; (3) Women aged 18-45 with regular menstrual cycle; (5) Informed consent, volunteer subjects and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Pregnant, lactating, perimenopausal women, intrauterine device users, severe menstrual cycle disorders such as hypogonadotropic menstrual disorders, hyperprolactinemia, polycystic ovary syndrome, patients with excessive menstrual flow anemia (Hb25mIU/ml. (7) Individuals with abnormal thyroid function. (8) Reproductive tract tumors affecting menstruation. (9) Patients with severe primary diseases such as heart, liver, kidney, and hematopoietic system, gastrointestinal ulcer disease, and mental illness; (10) Individuals with allergic constitution or allergic to the ingredients of this product; (11) Combined with severe acute and chronic infections and secondary kidney disease; (12) Pregnancy planning within 3 months; (13) Participants in other clinical trials within 3 months. (14) Suspected or confirmed history of alcohol or drug abuse, or other lesions or situations that, based on the researcher's judgment, reduce the likelihood of enrollment or complicate enrollment.

Design outcomes

Primary

MeasureTime frame
Breast lump;Breast pain;

Secondary

MeasureTime frame
Menstrual Traditional Chinese Medicine Symptom Score Table;Menstrual condition scoring table;Traditional Chinese Medicine Syndrome Score;Menstrual volume measurement (scoring by menstrual bleeding chart method);

Countries

China

Contacts

Public ContactXiaojun Zhang

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

zxj6298@sohu.com+86 138 0108 1032

Outcome results

None listed

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