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Treatment of breast hyperplasia with Xiangjurupining Capsule

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)

PHASE3 · Tasly Pharmaceutical Group Co., Ltd · NCT06685978

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

PhasePHASE3
Study typeInterventional
Enrollment430 (estimated)
Ages18 Years to 50 Years
SexFemale
SponsorTasly Pharmaceutical Group Co., Ltd (industry)
Locations27 sites (Beijing, Beijing Municipality and 26 other locations)
Trial IDNCT06685978 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 50 with diagnosed breast hyperplasia and specific symptom criteria.

Not a fit: Patients with conditions unrelated to liver-qi stagnation or phlegm coagulation may not benefit from this treatment.

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 performed: 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.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hyperplasia of Mammary Glands

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.