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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
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000053
Enrollment
Unknown
Registered
2023-10-06
Start date
2023-10-08
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

asthma

Interventions

Group 3:None. Only collect exhaled gas condensate for comparative analysis.
Group 2:Xiao'er Jiangqi Pingxiao Heji (XEJQPX) is given orally at 20 mL once for 3-6 years old and 25 mL once for 6 years old and above, 3 times a day. The course of treatment should be given for 7 co
Group 1: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 ea

Sponsors

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 syndrome criteria of external cold and internal heat syndrome of traditional Chinese medicine; 2. Age between 3 and 12 years old, regardless of gender; 3. Acute onset, according to the judgment standard, the condition is mild or moderate; 4. No treatment has been given in the past 3 days after the onset.

Exclusion criteria

Exclusion criteria: 1. Stable condition or in asthma remission; 2. Severe asthma, status asthmaticus, critically ill patients, and patients with pulmonary infection; 3. Those who are accompanied by other diseases that cause asthma or dyspnea in patients and affect the evaluation of curative effect; 4. Patients with primary diseases such as cardiovascular and cerebrovascular, liver and kidney, and hematopoietic system; 5. Those who are allergic to the ingredients of this study.

Design outcomes

Primary

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

Secondary

MeasureTime frame
FeNO;Exhaled breath condensate detection;Blood Eosinophil Count;Lung function indicators;

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