[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of cotton flower total flavonoids tablets in the treatment of mild and moderate Alzheimer's disease (AD) (marrow insufficiency/brain meridian stasis syndrome)
主要目的:
以棉花花总黄酮片模拟剂(安慰剂)为对照,初步评价棉花花总黄酮片治疗轻、中度阿尔茨海默病(髓海不足/脑络瘀阻证)的有效性和安全性,为后续临床试验设计提供依据。
次要目的:
评价棉花花总黄酮片治疗轻、中度阿尔茨海默病(髓海不足/脑络瘀阻证)的有效剂量及量效关系
[Translation] Main purpose:
Using cotton flower total flavonoids tablets simulant (placebo) as control, preliminarily evaluate the efficacy and safety of cotton flower total flavonoids tablets in the treatment of mild and moderate Alzheimer's disease (marrow sea insufficiency/brain collateral stasis syndrome), and provide a basis for the design of subsequent clinical trials.
Secondary purpose:
Evaluate the effective dose and dose-effect relationship of cotton flower total flavonoids tablets in the treatment of mild and moderate Alzheimer's disease (marrow sea insufficiency/brain collateral stasis syndrome).