[Translation] A multicenter, randomized, double-blind, placebo-controlled, multiple-dose phase IIa clinical trial to evaluate the safety/tolerability and efficacy of different doses of oral Jiuwei Jinqiao Granules combined with antibiotics for the conservative treatment of acute simple appendicitis (heat toxicity, qi stagnation and blood stasis syndrome)
以―随访结束时的痊愈率‖为主要疗效指标,采用随机、双盲单模拟、安慰剂对照、多中心临床试验设计,评价九味金翘颗粒联合抗生素用药对急性单纯性阑尾炎患者的安全性/耐受性和有效性的临床试验,并进行初步的剂量探索。
[Translation] Taking "cure rate at the end of follow-up" as the main efficacy indicator, a randomized, double-blind, single-dummy, placebo-controlled, multicenter clinical trial design was adopted to evaluate the safety/tolerability and efficacy of Jiuwei Jinqiao Granules combined with antibiotics in patients with acute simple appendicitis, and conduct preliminary dose exploration.