[Translation] A randomized, double-blind, placebo-controlled, multicenter, phase III clinical trial on the efficacy and safety of Guchong Granules in the treatment of menorrhagia (Spleen Qi deficiency syndrome)
(1)评价固冲颗粒治疗有排卵型功能失调性子宫出血月经过多(脾气虚证)患者经期出血量评分的下降情况、以及有效率和复发率。 (2)评价固冲颗粒治疗有排卵型功能失调性子宫出血月经过多(脾气虚证)患者中医证候疗效及中医单项症状疗效。 (3)评价固冲颗粒治疗有排卵型功能失调性子宫出血月经过多(脾气虚证)患者的安全性。
[Translation] (1) To evaluate the reduction of menstrual bleeding volume score, effective rate and recurrence rate of Guchong Granule in the treatment of patients with ovulatory dysfunctional uterine bleeding and menorrhagia (Spleen Qi deficiency syndrome). (2) To evaluate the efficacy of Guchong Granule in the treatment of patients with ovulatory dysfunctional uterine bleeding and menorrhagia (Spleen Qi deficiency syndrome) in terms of TCM syndrome and TCM single symptom. (3) To evaluate the safety of Guchong Granule in the treatment of patients with ovulatory dysfunctional uterine bleeding and menorrhagia (Spleen Qi deficiency syndrome).