A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule

A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule

The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.

This is a multicenter, randomized, open and parallel controlled clinical study.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.