Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06685978 | Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands | PHASE3 | RECRUITING | 430 | — | — | Apr 26, 2024 | Jul 31, 2026 | Nov 13, 2024 | 27 | China |
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.
| Arm | Type | Description |
|---|---|---|
| :Xiangjurupining Capsule Placebo group | PLACEBO_COMPARATOR | Xiang Ju Ru Pi Ning capsule Placebo(0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. |
| Xiangjurupining Capsule Experimental group | EXPERIMENTAL | Xiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. |
| Name | Type | Description |
|---|---|---|
| Xiang Ju Ru Pi Ning capsule Placebo | DRUG | 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 | DRUG | Xiang Ju Ru Pi Ning capsule (0.45g per capsule ) 4 capsules each time,p.o.,tid,for 3menstrual cycle. |
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 depres...