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A multicenter, prospective, randomized, double-blind, parallel controlled clinical trial of spleen Aminopeptide Oral Solution in the prevention and treatment of seasonal allergic rhinitis in children

A multicenter, prospective, randomized, double-blind, parallel controlled clinical trial of spleen Aminopeptide Oral Solution in the prevention and treatment of seasonal allergic rhinitis in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073443
Enrollment
Unknown
Registered
2023-07-11
Start date
2022-07-10
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Seasonal allergic rhinitis in children

Interventions

Sponsors

Beijing Children's Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Have a history of seasonal allergic rhinitis (hay fever), and be included in the group before this season's pollen dissemination, that is, before the onset of symptoms; 2. The age is 4-12 years old, male and female are not limited; 3. Subjects aged 5-12 years (not including 12), and have a history of seasonal allergic rhinitis for at least two years, with or without conjunctivitis; Subjects aged 4-5 years (not including 5) have a history of seasonal allergic rhinitis for at least one year, with or without conjunctivitis (consultation); 4. Meet the diagnostic criteria of allergic rhinitis, and refer to the guidelines for the diagnosis and treatment of allergic rhinitis (2022, Revised); 5. Among the four rhinitis symptoms (itchy nose, stuffy nose, sneezing and runny nose), the score of rhinitis symptoms is >= 2 points (the symptom score of the last pollen season collected by consultation); 6. Seasonal pollen serum specific IgE level 2 or above or skin pricks ++ or above; 7. Volunteer and sign the informed consent form; 8. Patients who have not received other allergy drugs or other types of immunomodulatory drugs within 4 weeks.

Exclusion criteria

Exclusion criteria: 1. The patients with nasal polyps and obvious structural abnormalities of nasal cavity are easy to cause abnormal ventilation function after physical examination; 2. Snoring with adenoidal hypertrophy and / or tonsillar hypertrophy during the screening evaluation period (consultation); 3. Past and present patients with interstitial lung disease, muscular dystrophy, congenital immunodeficiency, malignant tumors, autoimmune diseases, airway dysplasia and other major diseases; 4. Patients with oral disease, heart disease, chronic kidney disease and gastric ulcer during the screening and evaluation period (consultation); 5. People with perennial rhinitis (consultation); 6. Screening and evaluation: in the last pollen season, rhinitis can be relieved by itself without oral antihistamines or nasal spray of hormones (consultation); 7. Previous history of asthma; 8. Systemic glucocorticoids were used systematically within four weeks before taking medicine; 9. Those who have participated in other clinical trials within three months; 10. Any other circumstances that the researcher believes are not suitable for participating in the trial. Note: the inquiry information is only judged by the inquiry results.

Design outcomes

Primary

MeasureTime frame
Symptom score;Drug score;

Secondary

MeasureTime frame
Quality of life score;Total efficiency;Blood routine examination;Determination of cytokines in peripheral blood;

Countries

China

Contacts

Public ContactGe Wentong

Beijing Children's Hospital Affiliated to Capital Medical University

gwt@bch.com.cn+86 185 1130 5209

Outcome results

None listed

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