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This study will evaluate the efficacy and Safety of Xiangjurupining Capsule in the treatment of Hyperplasia of Mammary Glands(stagnation of liver-qi and phlegm).
Xiangjurupiling Capsule is an oral pure Chinese medicine preparation.This study will evaluate the efficacy and Safety of Xiangjurupining Capsule in the treatment of Hyperplasia of Mammary Glands(stagnation of liver-qi and phlegm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| :Xiangjurupining Capsule Placebo group | Placebo Comparator | Xiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. |
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| Xiangjurupining Capsule Experimental group | Experimental | Xiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiang Ju Ru Pi Ning capsule Placebo | Drug | Xiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain relief rate | Breast pain (NRS score) remission rate from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several 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. | Baseline to the 3rd menstrual cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Pain disappearance rate | Breast pain (NRS score) disappearance rate from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several 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. | Baseline to the 3rd menstrual cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu | Contact | 022-86343626 | liurui2@tasly.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital, Beijing University of Chinese Medicine | Recruiting | Beijing | Beijing Municipality | China |
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| Xiang Ju Ru Pi Ning capsule | Drug | Xiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. |
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| Changes in mean NRS scores from baseline within days of pain involvement | The mean value of breast pain per menstrual cycle was calculated from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several 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. | Baseline to the 3rd menstrual cycle |
| Changes in maximum NRS scores from baseline | Capture the highest value of breast pain per menstrual cycle from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several 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. | Baseline to the 3rd menstrual cycle |
| Change in pain AUC (area under pain-time curve) from baseline | The pain AUC was calculated from baseline based on the breast pain NRS score per menstrual cycle. | Baseline to the 3rd menstrual cycle |
| Change from baseline in days with NRS≥4 points | The number of days in each menstrual cycle with an NRS score greater than 4 for breast pain was captured from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several 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. | Baseline to the 3rd menstrual cycle |
| Within a few days of pain involvement within a menstrual cycle, the average NRS score decreased by 70% from baseline. | The mean NRS score decrease from baseline within days of pain involvement was 70%.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several 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. | Baseline to the 3rd menstrual cycle |
| TCM syndrome scores | Compared wth baseline;the scores of changes ofTCM syndrome Evaluaion at each visit .This instrument consists oftwo primary symptoms:breast pain,breast mas ,and foursecondary symptoms.fourlevels to measure severtyof primarysymptoms (0.2、4、6) and secondarysymptoms (0、1、2.3),respectively. Record the tongue and pulseconditions. The TCM syndrome efect calculated bynimodipine method. The final score has a rangeof0 to 100. The efect ofTCM syndrome from 0% negative) to 100%(disappear). | the 3rd menstrual cycle after treatment |
| SF-36V2 | Changes in SF-36 V2 scale scores and total scores from baseline.The SF-36 scale is a universal scale developed by the American medical research group to assess the quality of life (17 Appendix: SF-36 v2 rating scale), which is widely recognized and used in the world. The SF-36 v2 scale includes 36 entries that assess health-related quality of life in eight dimensions: physiological function (PF), physiological function (RP), physical pain (BP), general health (GH), vitality (VT), social function (SF), emotional function (RE), and mental health (MH). A Health Change (HT) entry is also included. The quality of life was retrospectively evaluated by the participants at visit 2, visit 5 and visit 6. The higher the score, the higher the quality of life. The results of V2 examination were used as the baseline to calculate the scores of all dimensions of quality of life and the total score. | the 3rd menstrual cycle after treatment |
| The target lump | Assess the scope the size and the hardness of the tareet lump by palpation.The doctor palpated the breast ofthe 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). | the 3rd menstrual cycle after treatment |
| The target lump area | Assess the breast glandular section thickness and nodules of the target lump area by B-ultrasound. | the 3rd menstrual cycle after treatment |
| East Hospital of Beijing University of Chinese Medicine | Recruiting | Beijing | Beijing Municipality | China |
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| Guang 'anmen Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Chongqing Traditional Chinese Medicine Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
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| Xiamen Hospital of Traditional Chinese Medicine | Recruiting | Xiamen | Fujian | China |
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| Guangdong Hospital of Traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | China |
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| Guang 'anmen Hospital Baoding Hospital | Recruiting | Baoding | Hebei | China |
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| Cangzhou Hospital of Integrated Chinese and Western Medicine | Recruiting | Cangzhou | Hebei | China |
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| Hebei Provincial Hospital of Traditional Chinese Medicine | Recruiting | Shijiazhuang | Hebei | China |
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| Oilfields General Hospital in Daqing | Recruiting | Daqing | Heilongjiang | China |
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| Luoyang Third People's Hospital | Recruiting | Luoyang | Henan | China |
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| Zhengzhou People's Hospital | Recruiting | Zhengzhou | Henan | China |
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| Wuhan Third Hospital | Recruiting | Wuhan | Hubei | China |
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| The First Affiliated Hospital of Hunan University of Chinese Medicine | Recruiting | Changsha | Hunan | China |
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| The First Affiliated Hospital of Hunan College of Traditional Chinese Medicine (Hunan Provincial Direct Hospital of Traditional Chinese Medicine) | Recruiting | Zhuzhou | Hunan | China |
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| Jiangsu Provincial Hospital of Traditional Chinese Medicine | Recruiting | Nanjing | Jiangsu | China |
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| Xuzhou Central Hospital | Recruiting | Xuzhou | Jiangsu | China |
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| North Jiangsu People's Hospital | Recruiting | Yangzhou | Jiangsu | China |
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| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Recruiting | Jinan | Shandong | China |
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| The Second Affiliated Hospital of Shandong First Medical University | Recruiting | Taian | Shandong | China |
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| Weifang Hospital of Traditional Chinese Medicine | Recruiting | Weifang | Shandong | China |
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| Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanxi Hospital of Traditional Chinese Medicine | Recruiting | Taiyuan | Shanxi | China |
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| The First Affiliated Hospital of Tianjin University of Chinese Medicine | Recruiting | Tianjin | Tianjin Municipality | China |
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| Urumqi maternal and child Health Care Hospital | Recruiting | Ürümqi | Xinjiang | China |
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| Zhejiang Provincal Hospital of TCM | Recruiting | Hangzhou | Zhejiangsheng | China |
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