[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial of Tutengcao granules in the treatment of acute gouty arthritis (damp-heat accumulation syndrome)
以“第7天用药结束后关节疼痛VAS评分较基线的变化值”为主要疗效指标,采用随机、双盲、安慰剂对照、多中心的临床试验设计,初步评价不同剂量土藤草颗粒治疗急性痛风性关节炎(湿热蕴结证)的有效性和安全性,并为Ⅲ期临床研究提供依据。
[Translation] Taking "the change in VAS score of joint pain compared with baseline after the end of medication on the 7th day" as the main efficacy indicator, a randomized, double-blind, placebo-controlled, multicenter clinical trial design was adopted to preliminarily evaluate the efficacy and safety of different doses of Tutengcao granules in the treatment of acute gouty arthritis (damp-heat accumulation syndrome), and provide a basis for Phase III clinical research.