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Clinical Trials in China / NCT06685978
Recruiting Phase 3

Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands

NCT06685978 · tracked via the Priya Life Science China tracker
Sponsor
Tasly Pharmaceutical Group Co., Ltd
Phase
Phase 3
Started
2024-04-26
Last updated
2024-11-13

Condition(s) studied

Hyperplasia of Mammary Glands

Investigational drug(s) / intervention(s)

Xiang Ju Ru Pi Ning capsule PlaceboXiang Ju Ru Pi Ning capsule

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.

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.

Study 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).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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 outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing Beijing Municipality Recruiting
East Hospital of Beijing University of Chinese Medicine Beijing Beijing Municipality Recruiting
Guang 'anmen Hospital Beijing Beijing Municipality Recruiting
Chongqing Traditional Chinese Medicine Hospital Chongqing Chongqing Municipality Recruiting
Xiamen Hospital of Traditional Chinese Medicine Xiamen Fujian Recruiting
Guangdong Hospital of Traditional Chinese Medicine Guangzhou Guangdong Recruiting
Guang 'anmen Hospital Baoding Hospital Baoding Hebei Recruiting
Cangzhou Hospital of Integrated Chinese and Western Medicine Cangzhou Hebei Recruiting
Hebei Provincial Hospital of Traditional Chinese Medicine Shijiazhuang Hebei Recruiting
Oilfields General Hospital in Daqing Daqing Heilongjiang Recruiting
Luoyang Third People's Hospital Luoyang Henan Recruiting
Zhengzhou People's Hospital Zhengzhou Henan Recruiting
Wuhan Third Hospital Wuhan Hubei Recruiting
The First Affiliated Hospital of Hunan University of Chinese Medicine Changsha Hunan Recruiting
The First Affiliated Hospital of Hunan College of Traditional Chinese Medicine (Hunan Provincial Direct Hospital of Traditional Chinese Medicine) Zhuzhou Hunan Recruiting
Jiangsu Provincial Hospital of Traditional Chinese Medicine Nanjing Jiangsu Recruiting
Xuzhou Central Hospital Xuzhou Jiangsu Recruiting
North Jiangsu People's Hospital Yangzhou Jiangsu Recruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine Jinan Shandong Recruiting
The Second Affiliated Hospital of Shandong First Medical University Taian Shandong Recruiting
Weifang Hospital of Traditional Chinese Medicine Weifang Shandong Recruiting
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine Shanghai Shanghai Municipality Recruiting
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai Shanghai Municipality Recruiting
Shanxi Hospital of Traditional Chinese Medicine Taiyuan Shanxi Recruiting
The First Affiliated Hospital of Tianjin University of Chinese Medicine Tianjin Tianjin Municipality Recruiting
Urumqi maternal and child Health Care Hospital Ürümqi Xinjiang Recruiting
Zhejiang Provincal Hospital of TCM Hangzhou Zhejiangsheng Recruiting

More Tasly Pharmaceutical Group Co., Ltd trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06685978 on ClinicalTrials.gov ↗ ← All trials in China