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A prospective, randomized, double-blind, parallel controlled clinical trial of spleen aminopeptide oral solution for the prevention and treatment of seasonal allergic rhinitis in children

A prospective, randomized, double-blind, parallel controlled clinical trial of spleen aminopeptide oral solution for the prevention and treatment of seasonal allergic rhinitis in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084131
Enrollment
Unknown
Registered
2024-05-11
Start date
2024-05-23
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

allergic rhinitis

Interventions

Sponsors

Beijing No.1 Biochemical Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Had a history of seasonal allergic rhinitis (hay fever) and was enrolled before the pollen spread of the season, that is, before the onset of symptoms; (2) Age 4-12 years old, male or female; (3) Subjects = 5 years of age < 12 years of age with a history of at least two years of seasonal allergic rhinitis, with or without conjunctivitis; Subjects = 4 years old and < 5 years old had a history of at least one year of seasonal allergic rhinitis with or without conjunctivitis (consultation), with seasonal exacerbation; (4) Meet the diagnostic criteria for allergic rhinitis, referring to the Guidelines for the Diagnosis and Treatment of allergic rhinitis (revised 2022); (5) Rhinitis symptom score =4 points among the four rhinitis symptoms (nasal itching, nasal congestion, sneezing and runny nose) (symptom score of the last pollen season was collected after consultation); (6) Seasonal pollen serum specific IgE above grade 2 or skin prick ++; (7) Voluntary test and signed informed consent; (8) Patients who have not received other allergy drugs or other classes of immunomodulatory drugs within 4 weeks.

Exclusion criteria

Exclusion criteria: (1) After physical examination, nasal polyps were found, and obvious nasal structure abnormalities were easy to cause ventilation Those with abnormal functions; (2) Obvious snoring accompanied by adenoid hypertrophy and/or tonsil fat during the screening evaluation period Large (consultation); (3) Past and present patients with interstitial lung disease, muscular dystrophy, congenital immune deficiency 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 (to diagnose); (5) Patients with perennial rhinitis (consultation); (6) Screening evaluation in the last pollen season, the onset of rhinitis does not require oral antihistamines or nasal treatment Those who can relieve themselves by spraying hormone (consultation); (7) Previous history of asthma; (8) Systemic use of glucocorticoids within four weeks prior to medication; (9) Participants in other clinical trials within three months; (10) Any other circumstances in which the investigator deems it inappropriate to participate in the trial. Note: Consultation information is only judged by consultation results.

Design outcomes

Primary

MeasureTime frame
Symptom score;

Secondary

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

Countries

China

Contacts

Public ContactWang Xiaoyue

The First Affiliated Hospital of Baotou Medical College

645914602@qq.com+86 139 4842 6155

Outcome results

None listed

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