红花丹皮酚膏治疗四肢急性闭合性软组织损伤(气滞血瘀证)评价其有效性与安全性的临床研究
[Translation] Clinical study on the effectiveness and safety of safflower paeonol ointment in the treatment of acute closed soft tissue injury of the limbs (Qi stagnation and blood stasis syndrome)
1.初步评价红花丹皮酚膏治疗四肢急性闭合性软组织损伤(气滞血瘀证)的临床有效性。
2. 为探索Ⅲ期临床试验的给药剂量提供依据。
3.评价红花丹皮酚膏的安全性。
[Translation] 1. To preliminarily evaluate the clinical effectiveness of safflower paeonol ointment in the treatment of acute closed soft tissue injury of the limbs (Qi stagnation and blood stasis syndrome).
2. To provide a basis for exploring the dosing of Phase III clinical trials.
3. To evaluate the safety of safflower paeonol ointment.
评价红花丹皮酚膏对健康受试者的耐受性和安全性的开放、随机、剂量递增、自身对照设计临床试验
[Translation] An open, randomized, dose-escalation, self-controlled clinical trial to evaluate the tolerability and safety of safflower paeonol cream in healthy subjects
选择健康人为受试者,从安全的初始剂量开始,考察人体对红花丹皮酚膏的耐受性和安全性,同时,观察红花丹皮酚膏对人体皮肤的刺激情况,为制定本品的Ⅱ期临床试验给药方案提供安全的剂量范围。
[Translation] Healthy subjects were selected as subjects, and starting from a safe initial dose, the tolerance and safety of safflower paeonol ointment were examined. At the same time, the irritation of safflower paeonol ointment on human skin was observed to provide a safe dosage range for formulating the dosing regimen for the Phase II clinical trial of this product.
参香养胃胶囊治疗消化性溃疡脾虚气滞证有效性和安全性的临床研究
[Translation] Clinical study on the efficacy and safety of Shenxiang Yangwei capsule in the treatment of peptic ulcer with spleen deficiency and qi stagnation syndrome
评价参香养胃胶囊治疗消化性溃疡脾虚气滞证的有效性,以及参香养胃胶囊临床应用的安全性
[Translation] To evaluate the effectiveness of Shenxiang Yangwei Capsule in treating peptic ulcer with spleen deficiency and qi stagnation syndrome, and the safety of Shenxiang Yangwei Capsule in clinical application
100 Clinical Results associated with Beijing Ruimeng Venture Technology Co., Ltd.
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100 Translational Medicine associated with Beijing Ruimeng Venture Technology Co., Ltd.