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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&#

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&#

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005488
Enrollment
Unknown
Registered
2022-01-03
Start date
2022-01-03
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute bronchitis cough in children

Interventions

control group:take Xiao'er Huangjin Zhike Granules placebo
treatment group:take Xiao'er Huangjin Zhike Granules

Sponsors

Beijing Children's Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Rate of cough disappearance/basic disappearance after 7 days of treatment.;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactBaoping XU
xubaopingbch@163.com13370115002

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026