[Translation] Evaluation of Shengruling Capsule in the treatment of breast hyperplasia (liver depression and phlegm stagnation syndrome): a randomized, double-blind, dose-finding, placebo-controlled, multicenter clinical study
1、以乳房疼痛改善情况、乳腺肿块大小改变情况以及中医证候改善情况为疗效指标,初步评价圣乳灵胶囊治疗乳腺增生病(肝郁痰凝证)的有效性,同时进行剂量探索研究。
2、通过临床不良事件观察,评价圣乳灵胶囊临床应用的安全性。
[Translation] 1. Using the improvement of breast pain, the change of breast mass size and the improvement of TCM symptoms as efficacy indicators, the effectiveness of Shengruling Capsules in treating breast hyperplasia (liver depression and phlegm stagnation syndrome) was preliminarily evaluated, and a dose exploration study was conducted at the same time.
2. The safety of the clinical application of Shengruling Capsules was evaluated through the observation of clinical adverse events.