NCT06685978 Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands
| NCT ID | NCT06685978 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tasly Pharmaceutical Group Co., Ltd |
| Condition | Hyperplasia of Mammary Glands |
| Study Type | INTERVENTIONAL |
| Enrollment | 430 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2026-04-30 |
Trial Parameters
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Brief 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 Criteria
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