A Study of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)

Study Overview
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Brief Summary
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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 .

Detailed Description
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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。

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study on the Efficacy and Safety of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)

Conditions
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Hyperplasia of Breast

Intervention / Treatment
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* Drug: xingjurupining capsule
* Drug: xiangjurupining capsule, xiangjurupining capsule placebo
* Drug: xiangjurupining capsule placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients aged 18-50 years. Those who meet the diagnostic criteria of breast hyperplasia and has a course of more than 3 months; Conform to the syndrome differentiation standard of liver depression and phlegm coagulation; Patients have a basic regular menstrual cycle (21-35 days) and a menstrual period (3-7 days) BI-RADS grade 2-3 NRS score ≥ 4 points in screening period The average score of NRS was ≥ 4 in the run-in period, and there was still a target lump in palpation Volunteer to participate in the experiment and sign the informed consent form after informed consent（Patients voluntarily accepted the test and gave informed consent） Exclusion Criteria: Patients with other breast diseases or other causes of breast pain, such as mastitis, breast cancer, etc. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, malignant tumor, blood system diseases and mental diseases. Patients who have been confirmed with dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome and hyperprolactinemia before, still need to be treated by regulating hormone level. Patients with previously confirmed hypercortisolism who still need to be treated with bromocriptine. Those with menstrual period more than 7 days, menopause and serious irregular menstrual cycle. Alt, AST, ALP, TBIL, GGT more than 1.2 times the upper limit of normal value; serum Cr, bun more than 1.2 times the upper limit of normal value, or blood, urine routine, ECG and other examination items are abnormal and of clinical significance. That who pregnant or lactating women, or have a pregnant plan within the next 6 months Chinese or Western medicine was used to treat hyperplasia of mammary gland within 1 month before the treatment and during run-in period(including external application medicine, acupuncture, etc.) and hormone drugs have been used within half a year (except for long-term oral contraceptives). Allergic constitution, known to be allergic to the ingredients of the prescription of the test drug History of alcohol or drug abuse. Participants in other clinical trials within 3 months before screening According to the judgment of the researchers, there are other diseases or situations that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in the working environment, which are likely to cause lost visits, and people with mental and behavioral disorders that cannot be based on the full informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose group<br>xiangjurupining capsule ,8 capsules，tid | Drug: xingjurupining capsule<br>* xingjurupining capsule,8 capsule,tid,3 months.<br>* Other names: High dose group;|
| Experimental: Lower dose group<br>xiangjurupining capsule, 4 capsules,tid, xiangjurupining capsule placebo ,4 capsules，tid，po | Drug: xiangjurupining capsule, xiangjurupining capsule placebo<br>* xiangjurupining capsule,4 capsules , and xiangjurupining capsule placebo,4 capsules,tid,3 months.<br>* Other names: Low dose group;|
| Placebo Comparator: Placebo group<br>xiangjurupining capsule placebo ,8 capsules，tid，po | Drug: xiangjurupining capsule placebo<br>* xiangjurupining capsule,8 capsule,tid,3 months.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperplasia of breast, Xiangjurupining capsule