Fibrocystic Disease of Breast
Conditions
Keywords
Multicenter, randomized, open, parallel controlled
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.
Interventions
DRUGXiaoru 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.
DRUGXiao 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.
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain of breast | after 30 days' treatment | According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch. |
| the size of breast lumps | after 30 days' treatment | Assess the size of breast lumps by breast ultrasonography or breast molybdenum target. |
| the scope of breast lumps | after 30 days' treatment | Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target. |
| the hardness of breast lumps | after 30 days' treatment | Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| all adverse reactions after taking Xiaoru Sanjie capsule | after 30 days' treatment | Number of Participants with different adverse reactions after taking treatment. |
| the level of estrogen | after 30 days' treatment | — |
| the level of progestin | after 30 days' treatment | — |
| the level of prolactin | after 30 days' treatment | — |
Countries
China
Contacts
Primary ContactYu Ren
Outcome results
None listed