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

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

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

Official Title
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A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule

Conditions
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Fibrocystic Disease of Breast

Intervention / Treatment
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* Drug: Xiaoru Sanjie capsules
* Drug: Xiao Yao pills


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xiaoru Sanjie capsules<br>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<br>* 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.<br>* Other names: Xiaoru Sanjie capsule;|
| Placebo Comparator: Xiao Yao pills<br>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<br>* 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.<br>* Other names: ease pills;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multicenter, randomized, open, parallel controlled