[Translation] Zaobai Anshen Granules for the treatment of insomnia (liver blood deficiency, internal disturbance of deficiency heat syndrome): a multicenter, randomized, double-blind, dose-finding, placebo-controlled phase II clinical trial
1.初步评价枣柏安神颗粒治疗失眠症(肝血不足,虚热内扰证)临床有效性和安全性。
2.探索枣柏安神颗粒治疗失眠症(肝血不足,虚热内扰证)临床剂量-效应关系,为III期临床试验给药剂量的选择提供依据。
[Translation] 1. To preliminarily evaluate the clinical efficacy and safety of Zaobai Anshen Granules in the treatment of insomnia (liver blood deficiency, internal disturbance of deficiency heat syndrome).
2. To explore the clinical dose-effect relationship of Zaobai Anshen Granules in the treatment of insomnia (liver blood deficiency, internal disturbance of deficiency heat syndrome), and provide a basis for the selection of the dosage for Phase III clinical trials.