[Translation] A randomized, double-blind, placebo-controlled, multicenter phase IIb clinical trial of the efficacy and safety of the treatment of acute migraine (blood stasis syndrome)
鼻脑通鼻用喷雾剂的临床定位为速效止痛。本项临床试验的目的是在鼻脑通鼻用喷雾剂人体局部耐受性临床试验及IIa期初步探索性试验基础上,拟定给药方案,进一步评价鼻脑通鼻用喷雾剂治疗偏头痛(血瘀证)急性期的有效性和安全性,为下一步临床试验提供设计依据。
[Translation] The clinical positioning of the Naotong nasal spray is rapid analgesia. The purpose of this clinical trial is to formulate a dosing regimen based on the local tolerance clinical trial of the Naotong nasal spray in humans and the preliminary exploratory trial of Phase IIa, to further evaluate the effectiveness and safety of the Naotong nasal spray in the acute stage of migraine (blood stasis syndrome), and to provide a design basis for the next clinical trial.