RecruitingPhase 2Phase 3NCT06747130

Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients

Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients: a Randomized, Double-blind, Placebo Controlled, Superiority Trial


Sponsor

Phramongkutklao College of Medicine and Hospital

Enrollment

82 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if drug montelukast works to treat dengue in adults. It will also learn about the safety of drug montelukast . The main questions it aims to answer are: Does drug montelukast lower the incidence of liver enzyme elevations in participants ? What medical problems do participants have when taking drug montelukast ?


Eligibility

Min Age: 20 Years

Inclusion Criteria4

  • Patient age >18 years
  • Dengue infection diagnosed by NS1 antigen, or polymerase chain reaction
  • Admitted to the hospital
  • Written informed consent from patient or attending relative able to and willing to give informed consent

Exclusion Criteria11

  • Other possible cause of fever other than dengue infection
  • Pregnancy
  • Unable to take medication
  • Aminotransferase level above 150 U/l
  • Allergy to paracetamol or tramadol
  • Paracetamol indicated for condition other than dengue infection
  • Critically ill patient who need ICU or invasive ventilation support
  • History of cirrhosis
  • Unable to communicate
  • Other indication of montelukast
  • History of psychiatric illness

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Interventions

DRUGMontelukast

A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

DRUGMontelukast Placebo

A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter


Locations(1)

Phramongkutklao Hospital

Bangkok, Thailand

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NCT06747130


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