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Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2024-11-13
430
Participants Needed
27
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 50 (including boundary values)
- Diagnosed with breast hyperplasia in Western medicine with disease duration over 3 months
- Meet traditional Chinese medicine criteria for liver depression and phlegm coagulation syndrome
- Target breast ultrasound BI-RADS grade 2-3, non-target breast BI-RADS grade 1-3
- NRS pain score ≥ 4 during screening with a palpable target mass
- Average NRS pain score ≥ 4 during introduction with palpable target mass
- More than 7 days of pain during the menstrual cycle in the introduction period
- Provide informed consent and voluntarily participate in the study
You will not qualify if you...
- Other breast diseases or breast pain causes like mastitis or breast cancer
- Severe cardiovascular, cerebrovascular, liver, kidney diseases, malignant tumors, blood diseases, or psychiatric disorders
- Diagnosed with dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome, hyperprolactinemia, Cushing's syndrome, or other hormone-related diseases requiring treatment
- Long-term use of painkillers for conditions like dysmenorrhea and unable to stop during the trial
- Abnormal liver or kidney function considered clinically significant
- Pregnant, breastfeeding, menopausal women, or those planning pregnancy within 6 months
- Use of medicines or therapies for breast hyperplasia or pain within 1 month or 5 half-lives before screening, or contraceptives and sex hormones within 6 months
- Severe menstrual cycle irregularities (cycle >35 days or <21 days, period <3 days or >7 days)
- Known allergies to components of the study drug
- History or suspicion of alcohol or drug abuse
- Participation in other clinical trials or use of investigational drugs within 1 month
- Failure to use approved contraceptive methods
- Other conditions that may affect study participation or follow-up as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
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2
East Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
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3
Guang 'anmen Hospital
Beijing, Beijing Municipality, China
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4
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
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5
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
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6
Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
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7
Guang 'anmen Hospital Baoding Hospital
Baoding, Hebei, China
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8
Cangzhou Hospital of Integrated Chinese and Western Medicine
Cangzhou, Hebei, China
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9
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
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10
Oilfields General Hospital in Daqing
Daqing, Heilongjiang, China
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11
Luoyang Third People's Hospital
Luoyang, Henan, China
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12
Zhengzhou People's Hospital
Zhengzhou, Henan, China
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13
Wuhan Third Hospital
Wuhan, Hubei, China
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14
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
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15
The First Affiliated Hospital of Hunan College of Traditional Chinese Medicine (Hunan Provincial Direct Hospital of Traditional Chinese Medicine)
Zhuzhou, Hunan, China
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16
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
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17
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
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18
North Jiangsu People's Hospital
Yangzhou, Jiangsu, China
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19
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
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20
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
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21
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China
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22
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
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23
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
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24
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China
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25
The First Affiliated Hospital of Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality, China
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26
Urumqi maternal and child Health Care Hospital
Ürümqi, Xinjiang, China
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27
Zhejiang Provincal Hospital of TCM
Hangzhou, Zhejiangsheng, China
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Research Team
R
Rui Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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