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&#

Phase 3

Conditions: Acute bronchitis cough in children

Registration Number: ITMCTR2200005488

Lead Sponsor: Beijing Children's Hospital,Capital Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of cough disappearance/basic disappearance after 7 days of treatment.;

Secondary Outcome Measures

Name	Time	Method
Cough severity-time area under the curve;Cough onset time;Evaluation of sputum viscosity;Cough disappear/almost disappear time;Phlegm symptom score;TCM syndrome effect;