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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.SG |
First Approval Date27 Sep 2022 |
评价复方银花解毒颗粒治疗儿童流行性感冒(风热证)的有效性和安全性的随机、双盲、安慰剂平行对照、多中心Ⅲ期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of compound Yinhua Jiedu granules in the treatment of influenza (wind-heat syndrome) in children
(1)确证评价复方银花解毒颗粒治疗儿童流行性感冒缩短病程及缩短热程、缓解症状、改善中医证候作用。(2)观察复方银花解毒颗粒临床应用的安全性。
[Translation] (1) To confirm and evaluate the efficacy of Compound Yinhua Jiedu Granules in shortening the course of illness and fever, relieving symptoms, and improving TCM syndromes in the treatment of influenza in children. (2) To observe the safety of Compound Yinhua Jiedu Granules in clinical application.
评价复方银花解毒颗粒治疗儿童流行性感冒(风热证)的有效性和安全性的随机、双盲、安慰剂平行对照、多中心Ⅱ期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of compound Yinhua Jiedu granules in the treatment of influenza (wind-heat syndrome) in children
主要目的:
初步评价复方银花解毒颗粒治疗儿童流行性感冒(风热证)的有效性。
次要目的:
初步评价复方银花解毒颗粒治疗儿童流行性感冒(风热证)的安全性。
[Translation] Main purpose:
To preliminarily evaluate the effectiveness of Compound Yinhua Jiedu Granules in treating influenza (wind-heat syndrome) in children.
Secondary purpose:
To preliminarily evaluate the safety of Compound Yinhua Jiedu Granules in treating influenza (wind-heat syndrome) in children.
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