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The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule in Hyperplastic disease of breast patients .
The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule,give three times a day versus placebo in Hyperplastic disease of breast patients .The clinical phase of the study comprises a run-in period,an 3-months double-blind treatment period and a 1-month follow-up period, resulting in 5-months overall duration of the study for each patient.
Patients report their breast pain as measured using NRS scale on the subject daily diary。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose group | Experimental | xiangjurupining capsule ,8 capsules,tid |
|
| Lower dose group | Experimental | xiangjurupining capsule, 4 capsules,tid, xiangjurupining capsule placebo ,4 capsules,tid,po |
|
| Placebo group | Placebo Comparator | xiangjurupining capsule placebo ,8 capsules,tid,po |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose Xiang Ju Ru Pi Ning capsule | Drug | xingjurupining capsule,8 capsule,tid,3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The pain of breast | Subject reported breast pain using NRS( Numerical Rating Scale)scale on the subject daily diary..The NRS scale is a line composed of 11 points, marked with a scale of 0 to 10. The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain. | up to 3 months |
| The days of pain | Subject reported breast pain as measured using NRS scale on the subject daily diary.The number of the pain days was calculated and compared with the baseline which the number of pain days in the lead-in period. | up to 3 months |
| The target lump | Assess the scope ,the size and the hardness of the target lump by palpation.The doctor palpated the breast of the subjects and measured the size of the target lump with a ruler.Four quadrant method was used to record the number of the target lump's quadrants.Four level(0,2,4,6) to measure The scope,the size and the hardness of lump .the Score from 0(none) to 6(most severe). | 3 months after treatment |
| The target lump area | Assess the breast glandular section thickness, breast duct width and nodules of the target lump area by B-ultrasound. | 3 months after treatment |
| TCM syndrome scores | Compared wth baseline,the scores of changes of TCM syndrome Evaluation at each visit .This instrument consists of two primary symptoms: breast pain, breast mass ,and four secondary symptoms.Four levels to measure severity of primary symptoms(0、2、4、6)and secondary symptoms(0、1、2、3), respectively. Record the tongue and pulse conditions. The TCM syndrome effect calculated by nimodipine method. The final score has a range of 0 to 100. The effect of TCM syndrome from 0% (negative ) to 100% (disappear). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baoding No.1 Hospital of TCM | Baoding | China | ||||
| Dongfang Hospital ,Beijing University of Chinese Medicine |
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| Low dose Xiang Ju Ru Pi Ning capsule | Drug | xiangjurupining capsule,4 capsules , and xiangjurupining capsule placebo,4 capsules,tid,3 months. |
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| Xiang Ju Ru Pi Ning capsule placebo | Drug | xiangjurupining capsule,8 capsule,tid,3 months. |
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| 3 months after treatment |
| Beijing |
| China |
| Dongzhimen Hospital,Beijing University of Chinese Medicine | Beijing | China |
| Guangdong Provincial Hospital of TCM | Guangzhou | China |
| the First Affiliated Hospital of Guangzhou University of TCM | Guangzhou | China |
| Longhua Hospital, Shanghai University of Traditional Chinese Medicine | Shanghai | China |
| SHUGUANG Hospital, Shanghai University of Traditional Chinese Medicine | Shanghai | China |
| Weifang Traditional Chinese Hospital | Weifang | China |
| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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