[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial on the efficacy and safety of Zhengrutie in the treatment of breast hyperplasia (liver depression and phlegm stagnation syndrome, Nouchou disease)
在Ⅱa期临床试验基础上,进一步评价正乳贴治疗乳腺增生病(肝郁痰凝证、努凑病)的有效性,包括缓解疼痛、消除肿块、改善症状的作用,以及藏医疗效、中医证候疗效等;同时观察本品安全性,为Ⅲ期临床试验设计提供依据。
[Translation] On the basis of the Phase IIa clinical trial, the effectiveness of the positive breast patch in treating breast hyperplasia (liver depression and phlegm stagnation syndrome, Nucou disease) was further evaluated, including its effects in relieving pain, eliminating lumps, improving symptoms, as well as its Tibetan medical efficacy and TCM syndrome efficacy; at the same time, the safety of this product was observed to provide a basis for the design of the Phase III clinical trial.