Overview

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

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Criteria
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.