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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
430
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 (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle.
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
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Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
RECRUITINGEast Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
RECRUITINGGuang 'anmen Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGXiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
RECRUITINGGuangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGGuang 'anmen Hospital Baoding Hospital
Baoding, Hebei, China
RECRUITINGCangzhou Hospital of Integrated Chinese and Western Medicine
Cangzhou, Hebei, China
RECRUITINGHebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
RECRUITINGOilfields General Hospital in Daqing
Daqing, Heilongjiang, China
RECRUITING...and 17 more locations
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