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治疗偏头痛(血瘀证)急性期的有效性及安全性的随机、双盲、安慰剂平行对照、多中心Ⅱa期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial on the efficacy and safety of the treatment of acute migraine (blood stasis syndrome)
与安慰剂对照,初步评价鼻脑通鼻用喷雾剂小剂量(1喷/头痛发作)治疗偏头痛(血瘀证)急性期的止痛作用特点,同时观察本品的局部耐受性和安全性,为下一步临床试验提供设计依据。
[Translation] Compared with placebo, the analgesic effect of a small dose of Nasotong nasal spray (1 spray/headache attack) in the treatment of acute migraine (blood stasis syndrome) was preliminarily evaluated. At the same time, the local tolerance and safety of the product were observed to provide a design basis for the next clinical trial.
/ Active, not recruitingPhase 2 治疗偏头痛(血瘀证)急性期的有效性及安全性的随机、双盲、 安慰剂平行对照的、多中心IIb期临床试验
[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.
鼻脑通用喷雾剂与安慰平行对照的、随机、双盲、 人体局部耐受性及安全性临床试验
[Translation] A randomized, double-blind, human local tolerance and safety clinical trial of nasal and cerebral universal spray in parallel with placebo
选择鼻黏膜正常的志愿受试者,观察鼻脑通用喷雾剂的局部耐受性以及药后鼻腔局部的变化,包括本品对鼻粘膜的影响,为本品提供安全性信息,并为下一步临床试验提供设计依据。
[Translation] Select voluntary subjects with normal nasal mucosa to observe the local tolerance of the nasal-brain universal spray and the local changes in the nasal cavity after medication, including the effect of this product on the nasal mucosa, to provide safety information for this product and provide a design basis for the next clinical trial.
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