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

NCT02929420 | Unknown Phase 4 DMC

• 1 other identifier: ry-2016-08
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibrocystic Disease of Breast

Keywords

Multicenter; randomized; open; parallel controlled

Outcome Measures

Primary Outcomes (12)

• the size of breast lumps

  Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.

  after 30 days' treatment

• the size of breast lumps

  Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.

  after 60 days' treatment

• the size of breast lumps

  Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.

  after 90 days' treatment

• the scope of breast lumps

  Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.

  after 30 days' treatment

• the scope of breast lumps

  Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.

  after 60 days' treatment

• the scope of breast lumps

  Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.

  after 90 days' treatment

• the hardness of breast lumps

  Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.

  after 30 days' treatment

• the hardness of breast lumps

  Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.

  after 60 days' treatment

• the hardness of breast lumps

  Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.

  after 90 days' treatment

• pain of breast

  According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.

  after 30 days' treatment

• pain of breast

  According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.

  after 60 days' treatment

• pain of breast

  According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.

  after 90 days' treatment

Secondary Outcomes (12)

• all adverse reactions after taking Xiaoru Sanjie capsule

  after 30 days' treatment

• all adverse reactions after taking Xiaoru Sanjie capsule

  after 60 days' treatment

• all adverse reactions after taking Xiaoru Sanjie capsule

  after 90 days' treatment

• the level of estrogen

  after 30 days' treatment

• the level of estrogen

  after 60 days' treatment

Study Arms (2)

Xiaoru Sanjie capsules

EXPERIMENTAL

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

Drug: Xiaoru Sanjie capsules

Xiao Yao pills

PLACEBO COMPARATOR

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.

Drug: Xiao Yao pills

Interventions

Xiaoru Sanjie capsules DRUG

Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.

Also known as: Xiaoru Sanjie capsule

Xiaoru Sanjie capsules

Xiao Yao pills DRUG

Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.

Also known as: ease pills

Xiao Yao pills

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

Yu Ren

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Fibrocystic Breast Disease

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yu Ren, MD,PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Ren

CONTACT

13700222161; renyyyyy@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: October 11, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 11, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)