ITMCTR2024000165暂停4 期
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)
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 45（—）
- 性别
- Female
入选标准
- •(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.
排除标准
- •(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.
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