[Translation] A randomized, double-blind, parallel-controlled, multicenter exploratory phase II clinical trial evaluating the efficacy and safety of Sanyuan Rupixiao Gel Patch in the treatment of hyperplasia of mammary glands with Qi stagnation and blood stasis 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 the treatment of hyperplasia of mammary glands with qi stagnation and blood stasis syndrome;
2. Preliminary evaluation of the safety of Sanyuan Rupixiao Gel Patch in the treatment of hyperplasia of mammary glands mainly with Qi stagnation and blood stasis syndrome;
3. To provide a scientific basis for determining the reasonable dose of Sanyuan Rupixiao Gel Patch to enter the Phase III clinical trial.