Treatment of breast hyperplasia with Xiangjurupining Capsule
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Clinical Trial of Efficacy and Safety of Xiangjurupining Capsule in the Treatment of Hyperplasia of Mammary Glands(Syndrome of Stagnation of Liver-qi and Phlegm)
Run by Tasly Pharmaceutical Group Co., Ltd · NCT06685978 · Data updated 2026-11-12
This study is testing if a traditional Chinese medicine called Xiangjurupining Capsule can help women aged 18 to 50 with breast hyperplasia feel better and improve their breast health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 430 (estimated) |
| Sponsor | Tasly Pharmaceutical Group Co., Ltd Industry-sponsored |
| Locations | 27 sites (Beijing, Beijing Municipality and 26 other locations) |
| Status | Recruiting |
| Started | April 26, 2024 |
| Main results expected | April 30, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | November 13, 2024 |
| Trial ID | NCT06685978 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are females aged 18 to 50 with diagnosed breast hyperplasia and specific symptom criteria.
✕Probably not a fit
Patients with conditions unrelated to liver-qi stagnation or phlegm coagulation may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the efficacy and safety of Xiangjurupining Capsule, a traditional Chinese medicine, for treating hyperplasia of mammary glands characterized by stagnation of liver-qi and phlegm. Female patients aged 18 to 50 with a diagnosis of breast hyperplasia will be enrolled. Participants will receive either the Xiangjurupining Capsule or a placebo, and their outcomes will be assessed based on pain levels and ultrasound findings. The study aims to determine if this herbal treatment can effectively alleviate symptoms and improve breast health.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for women suffering from breast hyperplasia.
How similar studies have gone: While this approach is based on traditional Chinese medicine, similar studies have shown promise in treating related conditions, though this specific formulation may be novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female patients aged 18 to 50 (including boundary values); 2. Those who meet the diagnostic criteria for breast hyperplasia in Western medicine and have a disease course of more than 3 months; 3. Meets the traditional Chinese medicine differentiation criteria for liver depression and phlegm coagulation syndrome; 4. The BI-RADS grading of the target side breast ultrasound is 2-3 levels, while the BI-RADS grading of the non target side breast ultrasound is 1-3 levels; 5. During the screening period, the NRS score is ≥ 4 and there is a target mass detected by palpation; 6. During the introduction period, the average NRS score within the day of pain involvement is ≥ 4 points, and there is still the presence of the target mass on palpation; 7. During the import period, the number of days with pain involvement in the menstrual cycle is greater than 7 days; 8. With informed consent, voluntarily participate in the experiment and sign the informed consent form. Exclusion Criteria: 1. Those who suffer from other breast diseases or breast pain caused by other reasons, such as mastitis, breast cancer, etc; 2. Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and psychiatric disorders; 3. Patients who have been previously diagnosed with dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome, hyperprolactinemia, Cushing's syndrome, and other diseases and still require treatment by adjusting hormone levels; Individuals who have been diagnosed with diseases that require long-term use of painkillers, such as dysmenorrhea, and are expected to be unable to stop using painkillers during the trial period. 4. Abnormal liver function (ALT or AST or ALP or GGT\>1.2 times the upper limit of normal values) or abnormal kidney function (serum Cr or BUN or Urea\>1.2 times the upper limit of normal values) that the researcher considers clinically significant and is not suitable for participation in clinical trials; 5. Women who are in pregnancy, lactation, menopause, or have a pregnancy plan within the past 6 months; 6. Chinese and western medicines and other therapies (including external application medicine, acupuncture and moxibustion, etc.) used to treat breast hyperplasia or relieve breast pain within 1 month or 5 half lives (whichever is the shortest) before screening and during the induction period, or contraceptives and sex hormone drugs have been used within half a year; 7. Individuals with severe menstrual cycle and/or menstrual irregularities (menstrual cycle\>35 days or\<21 days and/or menstrual period\<3 days or\>7 days); 8. Individuals with allergic constitution and known allergies to the components of the experimental drug prescription; 9. Suspect or have a history of alcohol and drug abuse; 10. Select patients who have participated in clinical trials and used investigational drugs within the previous month; 11. Failure to follow the physical contraceptive measures recognized by researchers for contraception; 12. According to the researchers' assessment, there may be other conditions or conditions that reduce the likelihood of inclusion or complicate the trial, such as frequent changes in the work environment that can lead to loss to follow-up, and individuals who cannot provide sufficient informed consent due to mental and behavioral disorders.
Where it's running
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Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China Recruiting -
East Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China Recruiting -
Guang 'anmen Hospital
Beijing, Beijing Municipality, China Recruiting -
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China Recruiting -
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China Recruiting -
Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China Recruiting
Show 21 more locations
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Guang 'anmen Hospital Baoding Hospital
Baoding, Hebei, China Recruiting -
Cangzhou Hospital of Integrated Chinese and Western Medicine
Cangzhou, Hebei, China Recruiting -
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China Recruiting -
Oilfields General Hospital in Daqing
Daqing, Heilongjiang, China Recruiting -
Luoyang Third People's Hospital
Luoyang, Henan, China Recruiting -
Zhengzhou People's Hospital
Zhengzhou, Henan, China Recruiting -
Wuhan Third Hospital
Wuhan, Hubei, China Recruiting -
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China Recruiting -
The First Affiliated Hospital of Hunan College of Traditional Chinese Medicine (Hunan Provincial Direct Hospital of Traditional Chinese Medicine)
Zhuzhou, Hunan, China Recruiting -
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China Recruiting -
Xuzhou Central Hospital
Xuzhou, Jiangsu, China Recruiting -
North Jiangsu People's Hospital
Yangzhou, Jiangsu, China Recruiting -
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China Recruiting -
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China Recruiting -
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China Recruiting -
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China Recruiting -
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China Recruiting -
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China Recruiting -
The First Affiliated Hospital of Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality, China Recruiting -
Urumqi maternal and child Health Care Hospital
Ürümqi, Xinjiang, China Recruiting -
Zhejiang Provincal Hospital of TCM
Hangzhou, Zhejiangsheng, China Recruiting
Study contacts
- Study coordinator: Rui Liu
- Email: liurui2@tasly.com
- Phone: 022-86343626
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.