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A multicentre pre-randomised clinical study of Xiao'er Jiangqi Pingxiao Heji in the treatment of asthma exacerbations in children

A multicentre pre-randomised clinical study of Xiao'er Jiangqi Pingxiao Heji in the treatment of asthma exacerbations in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071327
Enrollment
Unknown
Registered
2023-05-11
Start date
2023-05-12
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

asthma

Interventions

Western Medicine Group:Weight <20 kg, budesonide suspension 2 mL, terbutaline sulphate nebulised solution 1 mL, ipratropium bromide solution 1 mL
For body weight = 20 kg, budesonide suspension 2 mL, terbutaline sulphate nebuliser 2 mL, ipratropium bromide solution 2 mL. Add to air compression pump nebulizer for nebulized inhalation for 15 min e
Combined Chinese and Western Medicine Group:On the basis of the treatment regimen of the Western medicine group, the combination of Pediatric Qi-Reducing and Roaring Compound is given orally at 20 mL
Normal group:None. Only collect exhaled gas condensate for comparative analysis.

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Anyone who meets the diagnostic criteria of Western medicine and the criteria of Chinese medicine evidence; (2) Aged between 3 and 12 years, regardless of gender; (3) Those who have an acute onset and whose condition is mild or moderate according to the criteria for assessment; (4) No treatment has been given in the last 3 days.

Exclusion criteria

Exclusion criteria: (1) Stable or in remission from asthma; (2) Severe asthma, persistent asthma, critically ill patients, and those with co-infections of the lungs; (3) Patients with other diseases that cause shortness of breath or dyspnea and affect the assessment of efficacy; (4) Patients with primary diseases of the cardiovascular, cerebrovascular, hepatic, renal and haematopoietic systems; (5) Patients who are allergic to the components of the drug used in this study.

Design outcomes

Primary

MeasureTime frame
Time for clinical symptoms to disappear;Chinese Medicine Evidence Score;

Secondary

MeasureTime frame
Lung function indicators;Blood Eosinophil Count;Exhaled breath condensate detection;Peak flow rate detection;

Countries

China

Contacts

Public ContactZhao Xia

Affiliated Hospital of Nanjing University of Chinese Medicine

zhaoxiahy@njucm.edu.cn+86 139 1599 4006

Outcome results

None listed

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