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The efficacy of buffered hypertonic saline nasal irrigation in children with uncontrollable allergic rhinitis : a double-blind randomized controlled trial

hypertonic saline nasal irrigation in children with uncontrollable allergic rhinitis: a double-blind randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250818012
Enrollment
106
Registered
2025-08-18
Start date
2024-05-24
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Allergic rhinitis children Allergic rhinitis, saline irrigation, children

Interventions

Participants will perform nasal irrigation using 180 ml of hypertonic saline solution, divided equally between both nostrils, twice daily for four weeks. Participants will be instructed on proper tech
Active Comparator Drug,Placebo Comparator Drug
Hypertonic Saline Nasal Irrigation,Isotonic Saline Nasal Irrigation

Sponsors

Khon Kaen university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 3-7 years. 2. Diagnosed with moderate to severe allergic rhinitis according to Thai clinical practice guidelines (2022). 3. Symptoms persist despite treatment with antihistamine and intranasal corticosteroid for at least two weeks.

Exclusion criteria

Exclusion criteria: 1. Anatomical abnormalities of the nasal structure. 2. Diagnosed with sinusitis or upper respiratory tract infections. 3. Primary ciliary defects affecting nasal mucociliary clearance.

Design outcomes

Primary

MeasureTime frame
Nasal Symptom Severity Week 4 Total Nasal Symptom Score (TNSS) and Visual Analog Scale (VAS)

Secondary

MeasureTime frame
Quality of Life and Satisfaction Week 4 7-Point Likert scale

Countries

Thailand

Contacts

Public ContactRattapon Uppala

Khon kaen university

rattapon@kku.ac.th043363012

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026