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

Last updated: October 7, 2016
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Overall Status: Trial Status Unknown

Phase

4

Condition

Cystic Fibrosis

Fibrocystic Breast Disease

Lung Disease

Treatment

N/A

Clinical Study ID

NCT02929420
ry-2016-08
  • Ages 18-65
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-65 years old female patients with cyclomastopathy who signed a written informedconsent.

  • The subjects voluntarily entered the clinical observation whom are hospitalizedpatients 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 Reportingand Data System.

Exclusion

Exclusion Criteria:

  • Women who are pregnant or lactating, and who has the history of periarthritis ofshoulder.

  • Excluding breast fibrocellular tumor, breast cancer and other breast diseases.

  • Patients with poor self coordination, mentally retarded patients, or havecardiovascular and cerebrovascular disease, severe organic disease, as well as thehematopoietic 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 ofpatients according to the investigators.

  • Patients who have received treatment of other diseases, and those treatment methodsand targets may have an impact on the indicators of this study.

Study Design

Total Participants: 600
Study Start date:
October 01, 2016
Estimated Completion Date:
December 31, 2017

Study Description

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

Connect with a study center

  • Yu Ren

    Xi'an, Shaanxi 710000
    China

    Active - Recruiting

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