[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial on the efficacy and safety of Xiangju Rupining Capsule in the treatment of breast hyperplasia (liver depression and phlegm stagnation syndrome)
主要目的:确证香橘乳癖宁胶囊治疗乳腺增生病(肝郁痰凝证)的有效性,确证相比于安慰剂,香橘乳癖宁胶囊可以有效增加疼痛缓解的患者比例。
次要目的:确证香橘乳癖宁胶囊治疗乳腺增生病(肝郁痰凝证)的有效性,确证相比于安慰剂,香橘乳癖宁胶囊可以有效增加疼痛消失的患者比例。 确证香橘乳癖宁胶囊治疗乳腺增生病(肝郁痰凝证)的有效性,确证相比于安慰剂,香橘乳癖宁胶囊可以有效减轻乳腺增生病(肝郁痰凝证)患者乳房疼痛以及肝郁痰凝证症状,改善生活质量。 确证香橘乳癖宁胶囊治疗乳腺增生病(肝郁痰凝证)患者的安全性。
[Translation] Primary objective: To confirm the effectiveness of Xiangju Rupining Capsules in the treatment of breast hyperplasia (liver depression and phlegm stagnation syndrome), and to confirm that Xiangju Rupining Capsules can effectively increase the proportion of patients with pain relief compared with placebo.
Secondary objective: To confirm the effectiveness of Xiangju Rupining Capsules in the treatment of breast hyperplasia (liver depression and phlegm stagnation syndrome), and to confirm that Xiangju Rupining Capsules can effectively increase the proportion of patients with pain relief compared with placebo. To confirm the effectiveness of Xiangju Rupining Capsules in the treatment of breast hyperplasia (liver depression and phlegm stagnation syndrome), and to confirm that Xiangju Rupining Capsules can effectively reduce breast pain and liver depression and phlegm stagnation symptoms in patients with breast hyperplasia (liver depression and phlegm stagnation syndrome) and improve their quality of life compared with placebo. To confirm the safety of Xiangju Rupining Capsules in the treatment of patients with breast hyperplasia (liver depression and phlegm stagnation syndrome).