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Trial record 9 of 1630 for:    Recruiting, Not yet recruiting, Available Studies | "Breast Diseases"

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

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ClinicalTrials.gov Identifier: NCT02929420
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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

Condition or disease Intervention/treatment Phase
Fibrocystic Disease of Breast Drug: Xiaoru Sanjie capsules Drug: Xiao Yao pills Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: ease pills




Primary Outcome Measures :
  1. the size of breast lumps [ Time Frame: after 30 days' treatment ]
    Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.

  2. the size of breast lumps [ Time Frame: after 60 days' treatment ]
    Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.

  3. the size of breast lumps [ Time Frame: after 90 days' treatment ]
    Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.

  4. the scope of breast lumps [ Time Frame: after 30 days' treatment ]
    Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.

  5. the scope of breast lumps [ Time Frame: after 60 days' treatment ]
    Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.

  6. the scope of breast lumps [ Time Frame: after 90 days' treatment ]
    Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.

  7. the hardness of breast lumps [ Time Frame: after 30 days' treatment ]
    Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.

  8. the hardness of breast lumps [ Time Frame: after 60 days' treatment ]
    Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.

  9. the hardness of breast lumps [ Time Frame: after 90 days' treatment ]
    Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.

  10. pain of breast [ Time Frame: after 30 days' treatment ]
    According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.

  11. pain of breast [ Time Frame: after 60 days' treatment ]
    According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.

  12. pain of breast [ Time Frame: after 90 days' treatment ]
    According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.


Secondary Outcome Measures :
  1. all adverse reactions after taking Xiaoru Sanjie capsule [ Time Frame: after 30 days' treatment ]
    Number of Participants with different adverse reactions after taking treatment.

  2. all adverse reactions after taking Xiaoru Sanjie capsule [ Time Frame: after 60 days' treatment ]
    Number of Participants with different adverse reactions after taking treatment.

  3. all adverse reactions after taking Xiaoru Sanjie capsule [ Time Frame: after 90 days' treatment ]
    Number of Participants with different adverse reactions after taking treatment.

  4. the level of estrogen [ Time Frame: after 30 days' treatment ]
  5. the level of estrogen [ Time Frame: after 60 days' treatment ]
  6. the level of estrogen [ Time Frame: after 90 days' treatment ]
  7. the level of progestin [ Time Frame: after 30 days' treatment ]
  8. the level of progestin [ Time Frame: after 60 days' treatment ]
  9. the level of progestin [ Time Frame: after 90 days' treatment ]
  10. the level of prolactin [ Time Frame: after 30 days' treatment ]
  11. the level of prolactin [ Time Frame: after 60 days' treatment ]
  12. the level of prolactin [ Time Frame: after 90 days' treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929420


Contacts
Contact: Yu Ren 13700222161 renyyyyy@126.com

Locations
China, Shaanxi
Yu Ren Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Yu Ren, MD, PhD    13700222161    renyyyyy@126.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Principal Investigator: Yu Ren, MD,PhD First Affiliated Hospital Xi'an Jiaotong University

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02929420     History of Changes
Other Study ID Numbers: ry-2016-08
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Multicenter
randomized
open
parallel controlled

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrocystic Breast Disease
Breast Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Skin Diseases