Back to resultsA Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule
Primary Purpose
Fibrocystic Disease of Breast
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xiaoru Sanjie capsules
Xiao Yao pills
Sponsored by
About this trial
This is an interventional treatment trial for Fibrocystic Disease of Breast focused on measuring Multicenter, randomized, open, parallel controlled
Eligibility 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.
Sites / Locations
- Yu RenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Xiaoru Sanjie capsules
Xiao Yao pills
Arm Description
a new recipe of traditional chinese medicine； Xiaoru Sanjie capsules,three pills every time,three time a day,PO, last three months.
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.
Outcomes
Primary Outcome Measures
the size of breast lumps
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
the size of breast lumps
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
the size of breast lumps
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
the scope of breast lumps
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
the scope of breast lumps
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
the scope of breast lumps
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
the hardness of breast lumps
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
the hardness of breast lumps
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
the hardness of breast lumps
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
pain of breast
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
pain of breast
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
pain of breast
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Secondary Outcome Measures
all adverse reactions after taking Xiaoru Sanjie capsule
Number of Participants with different adverse reactions after taking treatment.
all adverse reactions after taking Xiaoru Sanjie capsule
Number of Participants with different adverse reactions after taking treatment.
all adverse reactions after taking Xiaoru Sanjie capsule
Number of Participants with different adverse reactions after taking treatment.
the level of estrogen
the level of estrogen
the level of estrogen
the level of progestin
the level of progestin
the level of progestin
the level of prolactin
the level of prolactin
the level of prolactin
Full Information
NCT ID
NCT02929420
First Posted
August 23, 2016
Last Updated
October 7, 2016
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT02929420
Brief Title
A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule
Official Title
A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.
Detailed Description
This is a multicenter, randomized, open and parallel controlled clinical study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrocystic Disease of Breast
Keywords
Multicenter, randomized, open, parallel controlled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xiaoru Sanjie capsules
Arm Type
Experimental
Arm Description
a new recipe of traditional chinese medicine； Xiaoru Sanjie capsules,three pills every time,three time a day,PO, last three months.
Arm Title
Xiao Yao pills
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Xiaoru Sanjie capsules
Other Intervention Name(s)
Xiaoru Sanjie capsule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Xiao Yao pills
Other Intervention Name(s)
ease pills
Intervention Description
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.
Primary Outcome Measure Information:
Title
the size of breast lumps
Description
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
Time Frame
after 30 days' treatment
Title
the size of breast lumps
Description
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
Time Frame
after 60 days' treatment
Title
the size of breast lumps
Description
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
Time Frame
after 90 days' treatment
Title
the scope of breast lumps
Description
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
Time Frame
after 30 days' treatment
Title
the scope of breast lumps
Description
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
Time Frame
after 60 days' treatment
Title
the scope of breast lumps
Description
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
Time Frame
after 90 days' treatment
Title
the hardness of breast lumps
Description
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
Time Frame
after 30 days' treatment
Title
the hardness of breast lumps
Description
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
Time Frame
after 60 days' treatment
Title
the hardness of breast lumps
Description
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
Time Frame
after 90 days' treatment
Title
pain of breast
Description
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Time Frame
after 30 days' treatment
Title
pain of breast
Description
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Time Frame
after 60 days' treatment
Title
pain of breast
Description
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Time Frame
after 90 days' treatment
Secondary Outcome Measure Information:
Title
all adverse reactions after taking Xiaoru Sanjie capsule
Description
Number of Participants with different adverse reactions after taking treatment.
Time Frame
after 30 days' treatment
Title
all adverse reactions after taking Xiaoru Sanjie capsule
Description
Number of Participants with different adverse reactions after taking treatment.
Time Frame
after 60 days' treatment
Title
all adverse reactions after taking Xiaoru Sanjie capsule
Description
Number of Participants with different adverse reactions after taking treatment.
Time Frame
after 90 days' treatment
Title
the level of estrogen
Time Frame
after 30 days' treatment
Title
the level of estrogen
Time Frame
after 60 days' treatment
Title
the level of estrogen
Time Frame
after 90 days' treatment
Title
the level of progestin
Time Frame
after 30 days' treatment
Title
the level of progestin
Time Frame
after 60 days' treatment
Title
the level of progestin
Time Frame
after 90 days' treatment
Title
the level of prolactin
Time Frame
after 30 days' treatment
Title
the level of prolactin
Time Frame
after 60 days' treatment
Title
the level of prolactin
Time Frame
after 90 days' treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Ren
Phone
13700222161
Email
renyyyyy@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Ren, MD,PhD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yu Ren
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Ren, MD, PhD
Phone
13700222161
Email
renyyyyy@126.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule
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