A Phase 3 interventional study of Xiang Ju Ru Pi Ning capsule Placebo and Xiang Ju Ru Pi Ning capsule in Hyperplasia of Mammary Glands, sponsored by Tasly Pharmaceutical Group Co., Ltd. Recruiting at 27 sites in China. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by Tasly Pharmaceutical Group Co., Ltd (part of China Resources Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment
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).
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).
76 studies on the registry are indexed under Hyperplasia; 9 are open to participants now.
This study's planned enrollment of 430 is above the median of 60 across 51 interventional studies indexed under Hyperplasia.
Browse Hyperplasia studies →Tasly Pharmaceutical Group Co., Ltd is the lead sponsor of 32 studies on the registry; 17 are open to participants now.
First submitted before Tasly Pharmaceutical Group Co., Ltd became part of China Resources Pharmaceutical Group Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 (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 Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.
Also known as: Placebo group
Xiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.
Also known as: Experimental group
Pain relief rate
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.
Time frame: Baseline to the 3rd menstrual cycle
Pain disappearance rate
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.
Time frame: Baseline to the 3rd menstrual cycle
Changes in mean NRS scores from baseline within days of pain involvement
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.
Time frame: Baseline to the 3rd menstrual cycle
Changes in maximum NRS scores from baseline
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.
Time frame: Baseline to the 3rd menstrual cycle
Change in pain AUC (area under pain-time curve) from baseline
The pain AUC was calculated from baseline based on the breast pain NRS score per menstrual cycle.
Time frame: Baseline to the 3rd menstrual cycle
Change from baseline in days with NRS≥4 points
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.
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.
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.
Time frame: Baseline to the 3rd menstrual cycle
TCM syndrome scores
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).
Time frame: the 3rd menstrual cycle after treatment
SF-36V2
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.
Time frame: the 3rd menstrual cycle after treatment
The target lump
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).
Time frame: the 3rd menstrual cycle after treatment
The target lump area
Assess the breast glandular section thickness and nodules of the target lump area by B-ultrasound.
Time frame: the 3rd menstrual cycle after treatment
Plan to share: No
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