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)

Phase 4

• Conditions: breast hyperplasia (liver stagnation and blood stasis type)

• Registration Number: ITMCTR2024000165
• Lead Sponsor: Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Temporary halt
• Sex: Female
• Target Recruitment: Not specified

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

(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 (Hb<110g/L (11.0/dl)), and patients undergoing hormone therapy.
(2) Abnormal uterine bleeding, organic lesions of the uterus and ovaries, or reduced menstrual flow caused by surgery, such as postoperative adhesions in the uterine cavity or removal of benign ovarian tumors.
(3) Patients with breast inflammation, malignant breast tumors, and other breast diseases with surgical indications;
(4) Breast mass with a diameter greater than 1cm under ultrasound or a BI-RADS score greater than level 3;
(5) Individuals who have taken contraceptive pills and sex hormone drugs within the first 3 months of enrollment;
(6) Age<40 years old and FSH>25mIU/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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast lump;Breast pain;

Secondary Outcome Measures

Name	Time	Method
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);