Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands

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)

Overview

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).

Detailed description

Xiangjurupiling Capsule is an oral pure Chinese medicine preparation.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).

Interventions

• Drug Xiang Ju Ru Pi Ning capsule Placebo
  Xiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.
• Drug Xiang Ju Ru Pi Ning capsule
  Xiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.

Primary outcome measures

• Pain relief rate [Time frame: Baseline to the 3rd menstrual cycle]

Secondary outcome measures (10)

• Pain disappearance rate [Time frame: Baseline to the 3rd menstrual cycle]
• Changes in mean NRS scores from baseline within days of pain involvement [Time frame: Baseline to the 3rd menstrual cycle]
• Changes in maximum NRS scores from baseline [Time frame: Baseline to the 3rd menstrual cycle]
• Change in pain AUC (area under pain-time curve) from baseline [Time frame: Baseline to the 3rd menstrual cycle]
• Change from baseline in days with NRS≥4 points [Time frame: Baseline to the 3rd menstrual cycle]
• Within a few days of pain involvement within a menstrual cycle, the average NRS score decreased by 70% from baseline. [Time frame: Baseline to the 3rd menstrual cycle]
• TCM syndrome scores [Time frame: the 3rd menstrual cycle after treatment]
• SF-36V2 [Time frame: the 3rd menstrual cycle after treatment]
• The target lump [Time frame: the 3rd menstrual cycle after treatment]
• The target lump area [Time frame: the 3rd menstrual cycle after treatment]

Eligibility criteria

Inclusion criteria

• 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;
• During the screening period, the NRS score is ≥ 4 and there is a target mass detected by palpation;
• 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;
• During the import period, the number of days with pain involvement in the menstrual cycle is greater than 7 days;
• With informed consent, voluntarily participate in the experiment and sign the informed consent form.

Exclusion criteria

• 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;
• Women who are in pregnancy, lactation, menopause, or have a pregnancy plan within the past 6 months;
• 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;
• 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);
• Individuals with allergic constitution and known allergies to the components of the experimental drug prescription;
• Suspect or have a history of alcohol and drug abuse;
• Select patients who have participated in clinical trials and used investigational drugs within the previous month;
• Failure to follow the physical contraceptive measures recognized by researchers for contraception;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 27 centers

• Dongzhimen Hospital, Beijing University of Chinese Medicine — Beijing
• East Hospital of Beijing University of Chinese Medicine — Beijing
• Guang 'anmen Hospital — Beijing
• Chongqing Traditional Chinese Medicine Hospital — Chongqing
• Xiamen Hospital of Traditional Chinese Medicine — Xiamen
• Guangdong Hospital of Traditional Chinese Medicine — Guangzhou
• Guang 'anmen Hospital Baoding Hospital — Baoding
• Cangzhou Hospital of Integrated Chinese and Western Medicine — Cangzhou
• … and 19 more centers

Identifiers

NCT: NCT06685978 · TSL-TCM-XJRPNJN-III

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗