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Intranasal steroids alone and in combination with levocetirizine, and/or montelukast for moderate to severe allergic rhinitis in children

Intranasal steroids alone and in combination with levocetirizine, and/or montelukast for moderate to severe allergic rhinitis in children: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079369
Enrollment
64
Registered
2025-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: J309- Allergic rhinitis, unspecified

Interventions

Intervention1: Combination therapy of Intranasal steroid plus montelukast or/and Levocetrizine: Group 2: Intranasal steroid plus montelukast syrup Group 3: Intranasal steroid plus Levocetrizine Group

Sponsors

AIIMS NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with moderate to severe allergic rhinitis with i) two out of four cardinal symptoms of itching, sneezing, rhinorrhea and nasal block. ii) with symptoms moderate to severe in intensity-sleep disturbance, impaired sleep, impaired work/school

Exclusion criteria

Exclusion criteria: Recent (within last 1 month) nasal surgery

Design outcomes

Primary

MeasureTime frame
To determine the superiority of add-on therapy (INS+levocetirizine and/or montelukast) vs INS in children with moderate-severe allergic rhinitisTimepoint: At enrollment, 4 weeks and then 8 weeks—

Secondary

MeasureTime frame
Side effects of add-on therapy. ? Effectiveness of treatment modalities in treating specific symptoms of AR. ? Efficacy of the interventions on asthma control. ? Change on FeNO with the interventions. ? Night nasal symptoms Efficacy in children with positive and negative skin prick test. Timepoint: 4 weeks and 8 weeks—

Countries

India

Contacts

Public ContactDr Kana Ram Jat

AIIMS NEW DELHI

drkanaram@gmail.com919868152426

Outcome results

None listed

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