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Clinical study of "lung and nose treatment together" in the treatment of children with Combined allergic rhinitis and asthma syndrome(CARAS)

Clinical study of "lung and nose treatment together" in the treatment of children with Combined allergic rhinitis and asthma syndrome(CARAS)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000336
Enrollment
Unknown
Registered
2024-08-31
Start date
2024-08-10
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

combined allergic rhinitis and asthma syndrome

Interventions

control group:Mometasone furoate nasal spray + inhalation of budesonide/formoterol powder inhalation + oral Tongqiao Pingchuan decoction granule mimics
experimental group:Mometasone furoate nasal spray + budesonide/formoterol powder inhalation + Tongqiao Pingchuan decoction granules orally

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 11 Years

Inclusion criteria

Inclusion criteria: (1) The patients were 6-11 years old (< 12 years old), male or female, and came from the outpatient department. (2) The diagnostic criteria of CARAS in children were in accordance with the "Recommendations for the Standardized diagnosis and Treatment of Bronchial Asthma in Children (2020)" and the "Guidelines for the diagnosis and treatment of allergic rhinitis in Children (2022, Revised edition)". (3) Rhinitis was mild AR or intermittent moderate to severe AR; Asthma was in the non-acute stage, and the condition was mild persistent (level 2) and moderate persistent (level 3). (4) in accordance with the TCM syndrome of pathogenic wind invading the lung; (5) in accordance with the provisions of informed consent.

Exclusion criteria

Exclusion criteria: (1) children with nasal septum curvature, nasal polyps, sinusitis, abnormal nasal anatomy or other respiratory diseases; (2) other diseases causing asthma or dyspnea; (3) Patients with inadequate washout period before enrollment: 1) patients received immunotherapy within 1 month; 2) Systemic use of glucocorticoids within 2 weeks; 4) Systemic use of leukotriene receptor antagonists, theophyllines, or long-acting anticholinergic drugs within one week; 3) Systemic use of antihistamines within 5 days; 5) use of nasal decongestants and antihistamines within 3 days; (4) combined with cardiovascular and cerebrovascular diseases, hematopoietic system diseases, or serious diseases of other organs, such as heart, liver, kidney and other diseases; (5) patients with mental disorders, severe malnutrition and rickets; (6) patients with known allergies to the drugs used in this study (7)Any situation that the investigator believes would compromise patient safety or data quality.

Design outcomes

Primary

MeasureTime frame
TCM single symptom and syndrome scores;

Secondary

MeasureTime frame
Symptoms of asthma exacerbations were recorded;FnNO;The CARATkids test;The TNSS test;Percentage of eosinophils;lung function;Cumulative drug dosage;The C-ACT test;

Countries

CHINA

Contacts

Public ContactXue Zheng

Shanghai Municipal Hospital of Traditional Chinese Medicine

xuezheng@shutcm.edu.cn18621905133

Outcome results

None listed

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