A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- the size of breast lumps
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.
详细描述
This is a multicenter, randomized, open and parallel controlled clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-65 years old female patients with cyclomastopathy who signed a written informed consent.
- •The subjects voluntarily entered the clinical observation whom are hospitalized patients or outpatients with good compliance.
- •They have specific symptoms, such as distending pain of the breast, stabbing pain, dull pain and radiating pain.
- •They have specific physical sign, for example, we can touch block gland, granular, nodular or cord like glands and etc..
- •Breast ultrasound or molybdenum target show I-III class by Breast Imaging Reporting and Data System.
排除标准
- •Women who are pregnant or lactating, and who has the history of periarthritis of shoulder.
- •Excluding breast fibrocellular tumor, breast cancer and other breast diseases.
- •Patients with poor self coordination, mentally retarded patients, or have cardiovascular and cerebrovascular disease, severe organic disease, as well as the hematopoietic system disease or mental illness.
- •Be judged as over middle degree depression by the Hamilton's depression scale.
- •Allergic constitution patients, and people who are allergic to a variety of drugs.
- •Any medical history which may interfere with the test results or increase the risk of patients according to the investigators.
- •Patients who have received treatment of other diseases, and those treatment methods and targets may have an impact on the indicators of this study.
研究组 & 干预措施
Xiaoru Sanjie capsules
a new recipe of traditional chinese medicine； Xiaoru Sanjie capsules,three pills every time,three time a day,PO, last three months.
干预措施: Xiaoru Sanjie capsules (Drug)
Xiao Yao pills
a kind of traditional chinese medicine that is efficient and safe to treat hyperplasia of mammary glands.
Xiaoyao pills,three pills every time,three time a day,PO,last three months.
干预措施: Xiao Yao pills (Drug)
结局指标
主要结局
the size of breast lumps
时间窗: after 90 days' treatment
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
the scope of breast lumps
时间窗: after 90 days' treatment
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
the hardness of breast lumps
时间窗: after 90 days' treatment
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
pain of breast
时间窗: after 90 days' treatment
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
次要结局
- all adverse reactions after taking Xiaoru Sanjie capsule(after 90 days' treatment)
- the level of estrogen(after 90 days' treatment)
- the level of progestin(after 90 days' treatment)
- the level of prolactin(after 90 days' treatment)