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Drug Highest PhasePhase 2 |
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First Approval Date- |
[Translation] Phase I clinical tolerance trial of Sanhua powder injection
1、观察人体对注射用三花粉针剂的安全性、耐受性 2、探索安全有效的剂量,为制定Ⅱ期临床试验合理的给药方案提供依据
[Translation] 1. Observe the safety and tolerance of Sanhua powder injection in human body 2. Explore the safe and effective dosage to provide a basis for formulating a reasonable dosing regimen for Phase II clinical trial
注射用三花粉针剂治疗脑梗死急性期(瘀血阻络证)的有效性和安全性的随机盲法多中心Ⅱ期临床试验
[Translation] A randomized, blinded, multicenter phase II clinical trial on the efficacy and safety of Sanhua powder injection in the treatment of acute cerebral infarction (blood stasis and collateral obstruction syndrome)
注射用三花粉针剂处方由三七总皂苷、灯盏花素组成,故以注射用灯盏花素、注射用血塞通、安慰剂平行对照,初步评价注射用三花粉针剂治疗脑梗死急性期(瘀血阻络证)的有效性和安全性,为Ⅱb期临床试验提供依据。
[Translation] The prescription of Sanhua powder injection consists of Panax notoginseng total saponins and breviscapine. Therefore, breviscapine injection, Xuesetong injection and placebo were used in parallel to preliminarily evaluate the effectiveness and safety of Sanhua powder injection in the treatment of acute cerebral infarction (blood stasis and obstruction syndrome), providing a basis for Phase IIb clinical trials.
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