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Montelukast in dengue fever

Efficacy of Montelukast in reducing incidence of warning signs and severe disease in patients with dengue fever: a double-blind, placebo-controlled, randomized trial(MID Trial) - nil

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059752
Enrollment
240
Registered
2023-11-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: B978- Other viral agents as the cause ofdiseases classified elsewhere

Interventions

Intervention1: Drug Intervention: Montelukast 10 mg orally once daily + standard of care (symptomatic) 4 Weeks Control Intervention1: Placebo: Placebo + Standard of care treatment (symptomatic)

Sponsors

Indian Council Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years 2. Confirmed dengue fever (NS 1 positive)

Exclusion criteria

Exclusion criteria: 1. Presence of warning sign or features of severe dengue 2. Patients with concurrent other cause of fever 3. Known leukemia/bleeding disorder like ITP 4. Patients taking steroids 5. Already on montelukast for other indication 6. Pregnancy/lactation 7. Unable to take medicine by mouth 8. Refusal to give consent

Design outcomes

Primary

MeasureTime frame
Incidence of warning signs and severe disease in patients with dengue fever who receive Montelukast compared to those who receive a placebo.Timepoint: 5 days

Secondary

MeasureTime frame
1. Duration of fever in patients with dengue fever who receive Montelukast compared to those who receive a placebo. 2. Hospitalization rates in patients with dengue fever who receive Montelukast compared to those who receive a placebo. 3. Mortality rates in patients with dengue fever who receive Montelukast compared to those who receive a placebo. 4. Adverse events related to Montelukast treatment in patients with dengue fever. Timepoint: 3,6,12,24,36 months

Countries

India

Contacts

Public ContactDr MANISH SONEJA

AIIMS, New Delhi

manishsoneja@gmail.com9013074717

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026