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

Xi'an Jiaotong University

Status and phase: Unknown; Phase 4

Conditions: Fibrocystic Disease of Breast

Treatments: Drug: Xiao Yao pills; Drug: Xiaoru Sanjie capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02929420

ry-2016-08

Details and patient eligibility

About

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

Full description

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

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups, including a placebo group

Xiaoru Sanjie capsules

Experimental group

Description:

a new recipe of traditional chinese medicine； Xiaoru Sanjie capsules,three pills every time,three time a day,PO, last three months.

Treatment:

Drug: Xiaoru Sanjie capsules

Xiao Yao pills

Placebo Comparator group

Description:

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.

Treatment:

Drug: Xiao Yao pills