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三七活络膏治疗急性闭合性软组织损伤(气滞血瘀证)有效性安全性随机双盲安慰剂平行对照多中心临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial on the efficacy and safety of Sanqi Huoluo ointment in the treatment of acute closed soft tissue injury (Qi stagnation and blood stasis syndrome)
1)以疼痛改善情况为主要疗效指标,以中医证候及损伤部位功能恢复为次要疗效评标,客观评价三七活络膏治疗急性闭合性软组织损伤(气滞血瘀证)受试者的临床疗效;
2)以实验室检测指标、局部皮肤过敏和刺激反应及其他不良事件,客观评价三七活络膏的安全性。
3)探索三七活络膏合理用药剂量和疗程。
[Translation] 1) To objectively evaluate the clinical efficacy of Sanqi Huoluo Ointment in the treatment of subjects with acute closed soft tissue injury (Qi stagnation and blood stasis syndrome) with pain improvement as the primary efficacy indicator and TCM syndrome and functional recovery of the injured part as the secondary efficacy evaluation criteria;
2) To objectively evaluate the safety of Sanqi Huoluo Ointment based on laboratory test indicators, local skin allergies and irritation reactions and other adverse events.
3) To explore the reasonable dosage and course of treatment of Sanqi Huoluo Ointment.
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