Actively Recruiting
Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients: a Randomized, Double-blind, Placebo Controlled, Superiority Trial
Led by Phramongkutklao College of Medicine and Hospital · Updated on 2025-05-29
82
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Dengue is a serious and growing health problem in tropical regions, affecting nearly 4 billion people worldwide with about 400 million infections annually. It often leads to liver problems, including elevated liver enzymes that are linked to more severe disease and complications such as shock, bleeding, and kidney failure. Researchers are studying whether the drug montelukast can help reduce these liver enzyme elevations in adults with dengue, potentially improving outcomes by addressing the underlying inflammation and plasma leakage caused by leukotrienes. This trial compares montelukast, given as a 10 mg oral tablet daily for up to 10 days or until the patient recovers, to a placebo given on the same schedule. The study is randomized, double-blind, and placebo-controlled, aiming to assess montelukast's effect on liver enzyme levels and safety in adult dengue patients. Participants will be admitted to the hospital and monitored closely during the treatment period. Participants will be evaluated from enrollment through the treatment period, focusing on serum transaminase levels on the day of recovery, along with secondary outcomes such as length of hospital stay, rates of severe dengue and shock, and blood tests including hematocrit and platelet counts. Safety and adverse events will also be monitored. The total treatment and follow-up duration is up to 10 days or until recovery as determined by the attending physicians.
CONDITIONS
Brief Title
Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days or until recovery
Participants receive a 10 mg tablet of montelukast or placebo orally immediately and daily for 10 days or until recovery, whichever is shorter.
Daily visits or assessments during treatment
Trial Site Locations
Total: 1 location
1
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Actively Recruiting
Research Team
V
Vasin Vasikasin, MD PhD
K
Kotchaphon Waithayakul, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here