Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands

November 10, 2024 updated by: Tasly Pharmaceutical Group Co., Ltd

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

430

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: :Xiangjurupining Capsule Placebo group
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 Placebo
Xiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.
Other Names:
  • Placebo group
Experimental: Xiangjurupining Capsule Experimental group
Xiang Ju Ru Pi Ning capsule (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.
Other Names:
  • Experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to the 3rd menstrual cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain disappearance rate
Time Frame: Baseline to the 3rd menstrual cycle
Breast pain (NRS score) disappearance 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.
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
The mean value of breast pain per menstrual cycle was calculated 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.
Baseline to the 3rd menstrual cycle
Changes in maximum NRS scores from baseline
Time Frame: Baseline to the 3rd menstrual cycle
Capture the highest value of breast pain per menstrual cycle 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.
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
The pain AUC was calculated from baseline based on the breast pain NRS score per menstrual cycle.
Baseline to the 3rd menstrual cycle
Change from baseline in days with NRS≥4 points
Time Frame: Baseline to the 3rd menstrual cycle
The number of days in each menstrual cycle with an NRS score greater than 4 for breast pain was captured 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.
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
The mean NRS score decrease from baseline within days of pain involvement was 70%.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.
Baseline to the 3rd menstrual cycle
TCM syndrome scores
Time Frame: the 3rd menstrual cycle after treatment
Compared wth baseline;the scores of changes ofTCM syndrome Evaluaion at each visit .This instrument consists oftwo primary symptoms:breast pain,breast mas ,and foursecondary symptoms.fourlevels to measure severtyof primarysymptoms (0.2、4、6) and secondarysymptoms (0、1、2.3),respectively. Record the tongue and pulseconditions. The TCM syndrome efect calculated bynimodipine method. The final score has a rangeof0 to 100. The efect ofTCM syndrome from 0% negative) to 100%(disappear).
the 3rd menstrual cycle after treatment
SF-36V2
Time Frame: the 3rd menstrual cycle after treatment
Changes in SF-36 V2 scale scores and total scores from baseline.The SF-36 scale is a universal scale developed by the American medical research group to assess the quality of life (17 Appendix: SF-36 v2 rating scale), which is widely recognized and used in the world. The SF-36 v2 scale includes 36 entries that assess health-related quality of life in eight dimensions: physiological function (PF), physiological function (RP), physical pain (BP), general health (GH), vitality (VT), social function (SF), emotional function (RE), and mental health (MH). A Health Change (HT) entry is also included. The quality of life was retrospectively evaluated by the participants at visit 2, visit 5 and visit 6. The higher the score, the higher the quality of life. The results of V2 examination were used as the baseline to calculate the scores of all dimensions of quality of life and the total score.
the 3rd menstrual cycle after treatment
The target lump
Time Frame: the 3rd menstrual cycle after treatment
Assess the scope the size and the hardness of the tareet lump by palpation.The doctor palpated the breast ofthe subjects and measured the size of the target lump with a ruler .Four quadrant method was used to record the number of the target lump's quadrants. Four level(0.2.4.6)to measure The scope,the size and the hardness of lump .The score from 0(none) to 6(most severe).
the 3rd menstrual cycle after treatment
The target lump area
Time Frame: the 3rd menstrual cycle after treatment
Assess the breast glandular section thickness and nodules of the target lump area by B-ultrasound.
the 3rd menstrual cycle after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 10, 2024

First Posted (Estimated)

November 13, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 10, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSL-TCM-XJRPNJN-III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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