[Translation] A randomized, double-blind, placebo-controlled, multicenter, phase II clinical trial of Guizhi Tangju Granules to promote wound healing of diabetic foot ulcers (yin deficiency with heat toxicity or blood stasis syndrome)
(1)以安慰剂为对照,初步评价归知糖疽颗粒促进糖尿病足(阴虚兼热毒或血瘀证)溃疡创面愈合的有效性。 (2)初步评价归知糖疽颗粒在糖尿病足(阴虚兼热毒或血瘀证)患者中使用的安全性。 (3)根据以上结果,为Ⅲ期试验提供依据。
[Translation] (1) Using placebo as control, preliminarily evaluate the effectiveness of Guizhi Tangwu Granules in promoting wound healing of diabetic foot (yin deficiency with heat toxicity or blood stasis syndrome). (2) Preliminarily evaluate the safety of Guizhi Tangwu Granules in patients with diabetic foot (yin deficiency with heat toxicity or blood stasis syndrome). (3) Based on the above results, provide a basis for Phase III trials.