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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.
This is a multicenter, randomized, open and parallel controlled clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xiaoru Sanjie capsules | Experimental | a new recipe of traditional chinese medicineï¼› Xiaoru Sanjie capsules,three pills every time,three time a day,PO, last three months. |
|
| Xiao Yao pills | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiaoru Sanjie capsules | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Ren | Contact | 13700222161 | renyyyyy@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Ren, MD,PhD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yu Ren | Recruiting | Xi'an | Shaanxi | 710000 | China |
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|
| Xiao Yao pills | Drug | 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. |
|
|
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 |
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 |
| ID | Term |
|---|---|
| D005348 | Fibrocystic Breast Disease |
| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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