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A randomized, double-blind, placebo-controlled, multicenter clinical trial on the efficacy and safety of Xiao'er Qingrexuanfei Plaster in the treatment of acute bronchitis (rheumatic pulmonary syndrome) in children.

A randomized, double-blind, placebo-controlled, multicenter clinical trial on the efficacy and safety ofXiao'er Qingrexuanfei Plaster in the treatment of acute bronchitis (rheumatic pulmonary syndrome) in children.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076373
Enrollment
Unknown
Registered
2023-10-07
Start date
2023-10-10
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

Pediatric acute bronchitis

Interventions

Test group:Xiaoer Qingre Xuanfei Plaster,external. Apply it to Danzhong (the middle line of the chest is parallel to the space between the fourth rib, which is about the midpoint of the line between t
over 3 years old to 7 years old: 2 stickers each before and after each time. Once a day, apply before bed every night and remove for 12 hours.
control group:Xiaoer Qingrexuanfei Plaster Simulator,external. Apply it to Danzhong (the middle line of the chest is parallel to the space between the fourth rib, which is about the midpoint of the li

Sponsors

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 7 Years

Inclusion criteria

Inclusion criteria: (1) It conforms to the diagnostic criteria of western medicine for acute bronchitis and the criteria of traditional Chinese medicine for syndrome differentiation of wind heat invading the lung; (2) Age: 6 months to 7 years; (3) Course of disease = 2 days; (4) BSS ped total score = 5; (5) Temperature = 38.5 ? 24h before diagnosis; (6) The informed consent process complies with the regulations.

Exclusion criteria

Exclusion criteria: (1) Children suffering from acute infectious diseases such as measles, whooping cough, influenza, bronchial asthma, infant asthma induced by multiple factors and children with positive asthma prediction index, simple acute upper respiratory tract infection, suppurative tonsillitis, laryngitis, bronchiolitis, bronchopneumonia, pulmonary abscess, tuberculosis and other respiratory diseases; (2) Complicated with serious primary diseases such as heart, liver, kidney, digestive and hematopoietic systems, or severe malnutrition; (3) The white blood cell count, absolute value of neutrophil and CRP were all greater than ULN, and the investigator considered that the patient was infected by bacteria or needed antibiotic treatment; (4) The application site has skin lesions, such as trauma, ulcer, infection, eczema, etc; (5) People who have a history of severe skin allergy in the past, or who are allergic to the test drug, ingredient or dressing; (6) The researcher thinks it is not suitable for the participants. Withdrawal (abscission) criteria for subjects

Design outcomes

Primary

MeasureTime frame
Disease effective rate;

Secondary

MeasureTime frame
BSS ped rating;Score of cough symptoms;Cough onset time;Therapeutic effect of TCM syndrome;Efficacy of single symptom/sign;Disease cute rate;

Countries

China

Contacts

Public ContactXinmin Li

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

2467755681@qq.com+86 22 2798 6376

Outcome results

None listed

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