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.

Study Overview

• Status: Unknown
• Conditions: Fibrocystic Disease of Breast
• Intervention / Treatment: Drug: Xiaoru Sanjie capsules; Drug: Xiao Yao pills

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yu Ren; Phone Number: 13700222161; Email: renyyyyy@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • Yu Ren
      • Contact: Yu Ren, MD, PhD; Phone Number: 13700222161; Email: renyyyyy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xiaoru Sanjie capsules; 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; 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.; Other Names: Xiaoru Sanjie capsule
Placebo Comparator: Xiao Yao pills; 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; 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.; Other Names: ease pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
all adverse reactions after taking Xiaoru Sanjie capsule	Number of Participants with different adverse reactions after taking treatment.	after 30 days' treatment
all adverse reactions after taking Xiaoru Sanjie capsule	Number of Participants with different adverse reactions after taking treatment.	after 60 days' treatment
all adverse reactions after taking Xiaoru Sanjie capsule	Number of Participants with different adverse reactions after taking treatment.	after 90 days' treatment
the level of estrogen		after 30 days' treatment
the level of estrogen		after 60 days' treatment
the level of estrogen		after 90 days' treatment
the level of progestin		after 30 days' treatment
the level of progestin		after 60 days' treatment
the level of progestin		after 90 days' treatment
the level of prolactin		after 30 days' treatment
the level of prolactin		after 60 days' treatment
the level of prolactin		after 90 days' treatment

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Yu Ren, MD,PhD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: randomized; Multicenter; open; parallel controlled
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis; Breast Diseases; Fibrocystic Breast Disease
• Other Study ID Numbers: ry-2016-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes