[Translation] A randomized, double-blind, parallel-controlled, multicenter exploratory phase II clinical trial to evaluate the efficacy and safety of Sanyuan Rupixiao gel plaster in the treatment of breast hyperplasia with qi stagnation and blood stasis as the main syndrome
1. 初步评价三元乳癖消凝胶贴膏治疗以气滞血瘀证为主的乳腺增生症的有效性;
2. 初步评价三元乳癖消凝胶贴膏治疗以气滞血瘀证为主的乳腺增生症的安全性;
3. 为确定三元乳癖消凝胶贴膏进入Ⅲ期临床试验的合理剂量提供科学依据。
[Translation] 1. To preliminarily evaluate the effectiveness of Sanyuan Rupixiao Gel Patch in treating breast hyperplasia with qi stagnation and blood stasis syndrome as the main symptom;
2. To preliminarily evaluate the safety of Sanyuan Rupixiao Gel Patch in treating breast hyperplasia with qi stagnation and blood stasis syndrome as the main symptom;
3. To provide a scientific basis for determining the reasonable dosage of Sanyuan Rupixiao Gel Patch for Phase III clinical trials.