Clinical trial NCT06685978: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hyperplasia of Mammary Glands
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-13
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Pain relief rate
timeFrame: Baseline to the 3rd menstrual cycle
Secondary outcomes:
measure: Pain disappearance rate
timeFrame: Baseline to the 3rd menstrual cycle
measure: Changes in mean NRS scores from baseline within days of pain involvement
timeFrame: Baseline to the 3rd menstrual cycle
measure: Changes in maximum NRS scores from baseline
timeFrame: Baseline to the 3rd menstrual cycle
measure: Change in pain AUC (area under pain-time curve) from baseline
timeFrame: Baseline to the 3rd menstrual cycle
measure: Change from baseline in days with NRS≥4 points
timeFrame: Baseline to the 3rd menstrual cycle
measure: Within a few days of pain involvement within a menstrual cycle, the average NRS score decreased by 70% from baseline.
timeFrame: Baseline to the 3rd menstrual cycle
measure: TCM syndrome scores
timeFrame: the 3rd menstrual cycle after treatment
measure: SF-36V2
timeFrame: the 3rd menstrual cycle after treatment
measure: The target lump
timeFrame: the 3rd menstrual cycle after treatment
measure: The target lump area
timeFrame: the 3rd menstrual cycle after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital, Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: East Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Guang 'anmen Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hospital
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Hospital of Traditional Chinese Medicine
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Hospital of Traditional Chinese Medicine
state: Guangdong
city: Baoding
country: China
facility: Guang 'anmen Hospital Baoding Hospital
state: Hebei
city: Cangzhou
country: China
facility: Cangzhou Hospital of Integrated Chinese and Western Medicine
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Provincial Hospital of Traditional Chinese Medicine
state: Hebei
city: Daqing
country: China
facility: Oilfields General Hospital in Daqing
state: Heilongjiang
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou People's Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Third Hospital
state: Hubei
city: Changsha
country: China
facility: The First Affiliated Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Zhuzhou
country: China
facility: The First Affiliated Hospital of Hunan College of Traditional Chinese Medicine (Hunan Provincial Direct Hospital of Traditional Chinese Medicine)
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: North Jiangsu People's Hospital
state: Jiangsu
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Taian
country: China
facility: The Second Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Weifang
country: China
facility: Weifang Hospital of Traditional Chinese Medicine
state: Shandong
city: Shanghai
country: China
facility: Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Hospital of Traditional Chinese Medicine
state: Shanxi
city: Tianjin
country: China
facility: The First Affiliated Hospital of Tianjin University of Chinese Medicine
state: Tianjin
city: Ürümqi
country: China
facility: Urumqi maternal and child Health Care Hospital
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Provincal Hospital of TCM
state: Zhejiangsheng
Study officials:
References: