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Efficacy and safety evaluation of spleen Aminopeptide Oral Solution in the treatment of children with allergic rhinitis complicated with adenoidal hypertrophy

Efficacy and safety evaluation of spleen Aminopeptide Oral Solution in the treatment of children with allergic rhinitis complicated with adenoidal hypertrophy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056763
Enrollment
Unknown
Registered
2022-02-15
Start date
2022-02-12
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Allergic rhinitis with adenoid hypertrophy

Interventions

Control group:Loratadine for 1 month and isotonic nasal saline for 2 months
Test group:Loratadine (1 month) combined with spleen Aminopeptide Oral Solution (2 months), isotonic nasal saline for 2 months

Sponsors

Affiliated pediatric hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) 3 = age < 12 years, male or female; (2) Meet the diagnostic criteria of allergic rhinitis; (3) According to the diagnostic criteria of clinical adenoid hypertrophy, children with nasal degree II or above after adenoid obstruction were confirmed by nasal endoscopy, and the lateral X-ray of nasopharynx showed that the ratio of the maximum thickness of adenoid to the distance between the anterior and posterior diameter of nasopharynx (A / N) was 0.61 = A / N = 0.80; (4) The history of nasal congestion, cough and snoring is more than 3 months; (5) Patients who had not received other similar immunomodulatory drugs within 4 weeks; (6) No systemic hormone therapy was used within 3 months; (7) Volunteer to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Adenoidectomy was performed; (2) Rhinosinusitis associated with tonsillar hypertrophy, including nasal polyps, hypertrophy of inferior turbinate, severe deviation of nasal septum, nervous and muscular tension of the meatus, nasal masses, retrogression of the root of the tongue, and obstructive symptoms caused by obesity; (3) Acute upper and lower respiratory tract infection in recent 2 weeks; (4) Children with metabolic and immune deficiency diseases and severe organic diseases such as heart, liver, kidney and brain; (5) Patients considered unsuitable by the investigator for clinical study.

Design outcomes

Primary

MeasureTime frame
A / N ratio of adenoid hypertrophy;Endoscopic evaluation;

Secondary

MeasureTime frame
Symptom score(VAS);Drug score;

Countries

China

Contacts

Public ContactXu ZhengMin

Affiliated pediatric hospital of Fudan University

George501@sina.com18017590963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026