Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

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).

Eligibility criteria

Qualifiers

Female patients aged 18 to 50 (including boundary values);

Those who meet the diagnostic criteria for breast hyperplasia in Western medicine and have a disease course of more than 3 months;

Meets the traditional Chinese medicine differentiation criteria for liver depression and phlegm coagulation syndrome;

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;

Disqualifiers

Those who suffer from other breast diseases or breast pain caused by other reasons, such as mastitis, breast cancer, etc;

Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and psychiatric disorders;

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.

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;

Trial design

Treatments tested in this trial

  • Xiang Ju Ru Pi Ning capsule Placebo
  • Xiang Ju Ru Pi Ning capsule

Treatment groups

430 Participants
are divided into 2 treatment groups