NCT06685978RecruitingPhase 3
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)
Tasly Pharmaceutical Group Co., Ltd27 sites in 1 country430 target enrollmentStarted: April 26, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 430
- Locations
- 27
- Primary Endpoint
- Pain relief rate
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
:Xiangjurupining Capsule Placebo group
Placebo Comparator
Xiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.
Intervention: Xiang Ju Ru Pi Ning capsule Placebo (Drug)
Xiangjurupining Capsule Experimental group
Experimental
Xiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.
Intervention: Xiang Ju Ru Pi Ning capsule (Drug)
Outcomes
Primary Outcomes
Pain relief rate
Time Frame: Baseline to the 3rd menstrual cycle
Breast pain (NRS score) remission rate from baseline.Subject reported breast pain usingNRs( NumericalRatine Scalelscale onthe subiect daily diary.The NRS scale is a line composed of several points, marked with a scale of 0 to 10.The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
Secondary Outcomes
- TCM syndrome scores(the 3rd menstrual cycle after treatment)
- SF-36V2(the 3rd menstrual cycle after treatment)
- The target lump(the 3rd menstrual cycle after treatment)
- The target lump area(the 3rd menstrual cycle after treatment)
- Pain disappearance rate(Baseline to the 3rd menstrual cycle)
- Changes in mean NRS scores from baseline within days of pain involvement(Baseline to the 3rd menstrual cycle)
- Changes in maximum NRS scores from baseline(Baseline to the 3rd menstrual cycle)
- Change in pain AUC (area under pain-time curve) from baseline(Baseline to the 3rd menstrual cycle)
- Change from baseline in days with NRS≥4 points(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.(Baseline to the 3rd menstrual cycle)
Investigators
Study Sites (27)
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