[Translation] A prospective, randomized, double-blind, placebo- and active drug-controlled, multicenter phase II exploratory clinical study on the efficacy and safety of right lipoic acid lysine injection in the treatment of paresthesia caused by diabetic peripheral neuropathy
1、探索静脉滴注不同剂量的右硫辛酸赖氨注射液在糖尿病周围神经病变引起的感觉异常患者中的有效性,并与硫辛酸注射液(奥力宝®)进行对比研究。为 III 期临床试验设计提供依据。2、探索静脉滴注不同剂量的右硫辛酸赖氨注射液在糖尿病周围神经病变引起的感觉异常患者中的安全性,并与硫辛酸注射液(奥力宝®)进行对比研究。
[Translation] 1. To explore the effectiveness of different doses of intravenous infusion of right lipoic acid lysine injection in patients with sensory abnormalities caused by diabetic peripheral neuropathy, and to compare it with lipoic acid injection (Aolibao®). To provide a basis for the design of Phase III clinical trials. 2. To explore the safety of different doses of intravenous infusion of right lipoic acid lysine injection in patients with sensory abnormalities caused by diabetic peripheral neuropathy, and to compare it with lipoic acid injection (Aolibao®).