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临床试验/ITMCTR2200005488
ITMCTR2200005488尚未招募3 期

A randomized, double-blind, placebo-parallel controlled, multicenter Phase III clinical trial of efficacy and safety of Xiao'er Huangjin Zhike Granules in the treatment of acute bronchitis cough&#

Beijing Children's Hospital,Capital Medical University0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional study

入排标准

年龄范围
3 至 7(—)
性别
All

入选标准

  • (1) Consistent with the diagnosis of acute bronchitis in children;
  • (2) TCM syndrome differentiation is syndrome of phlegm heat obstructing lung;
  • (3) Aged between 3 and 7 (including 3 and 7 years old), regardless of gender;
  • (4) Cough symptom score =2 points in daytime or =2 points in night;
  • (5) Within 72 hours after the onset of acute bronchitis, no drugs with antitussive and expectorant effects or other treatments were used before treatment (except for those who only used once or twice and no drugs were used within 12 hours);
  • (6) The legal guardians of the children agreed that their children should participate in the study and sign the informed consent.

排除标准

  • (1) The highest body temperature within 24 hours before enrollment & GT; Children at 38.5?;
  • (2) children with measles, whooping cough, influenza and other acute infectious diseases;
  • (3) children with acute upper respiratory tract infection, bronchial asthma, bronchiolitis, asthmatic bronchitis, bronchopneumonia and other respiratory diseases;
  • (4) Children allergic to the test drug or its ingredients;
  • (5) children with malnutrition, immune deficiency and tuberculosis;
  • (6) Children who have participated in or are participating in clinical trials of other drugs within 1 month;
  • (7) children with serious primary diseases such as heart, liver, kidney, digestive and hematopoietic system;
  • (8) The researchers identified children who were not suitable for clinical trials.

研究者

发起方
Beijing Children's Hospital,Capital Medical University

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