Use of Rupatadine in the treatment of acute dengue infection

Effect of Rupatadine compared to placebo in the reducing complications of acute dengue infection

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2014/023

Enrollment

240

Registered

2014-10-02

Start date

2014-12-09

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

Dengue

Interventions

Consenting participants meeting the inclusion exclusion criteria will be randomized into 3 arms. Participants in arm A will receive one 10mg tablet of rupatadine, plus three placebo tablets once dai

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed dengue infection (positive dengue NS1 antigen detection test or presence of dengue specific antibodies) 2. Informed written consent 3. Age: between 18-60 years 4. Duration of illness: less than 5 days 5. No evidence of vascular leak.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Known allergies to antihistamines 3. Individuals who are homeless 4. Dependency on alcohol or abuse drugs 5. Hepatic impairment defined as: no previously known liver disease, prolonged prothromin time of 4-6 seconds or more, INR of >1.5 6. Renal impairment defined as: hypertension and diabetes, GFR 30 mg/g , hereditary kidney disease, recurrent or extensive nephrolithiasis, urinary red cell casts, red blood cell count >20 per high power field, Consistent albuminuria

Design outcomes

Primary

Measure	Time frame
1. Proportion of individuals who are treated with rupatadine who develop fluid leakage. 2. Reduction in fluid leakage by 50% or more in those who are treated with rupatadine. Fluid accumulation will be assessed by a semi quantitative measure, with classification of ascites as minimal, mild, moderate, severe & massive by looking for the presence of fluid in five areas of the abdomen namely RUQ (perihepatic and morrison's pouch), LUQ (perisplenic), right paracolic gutter, left paracolic gutter and pelvis [Clinical assessments will be carried out at least 3 times a day until discharge. Laboratory assessments will be carried out at least 4 times a day until discharge.]	—

Measure

Time frame

1. Proportion of individuals who are treated with rupatadine who develop fluid leakage. 2. Reduction in fluid leakage by 50% or more in those who are treated with rupatadine. Fluid accumulation will be assessed by a semi quantitative measure, with classification of ascites as minimal, mild, moderate, severe & massive by looking for the presence of fluid in five areas of the abdomen namely RUQ (perihepatic and morrison's pouch), LUQ (perisplenic), right paracolic gutter, left paracolic gutter and pelvis [Clinical assessments will be carried out at least 3 times a day until discharge. Laboratory assessments will be carried out at least 4 times a day until discharge.]

—

Secondary

Measure	Time frame
1. Liver failure 2. Shock 3. Need for colloids 4. Need for blood transfusion 5. Duration of illness 6. Return of haematocrit to baseline [Clinical assessments will be carried out at least 3 times a day until discharge. Laboratory assessments will be carried out at least 4 times a day until discharge.]	—

Countries

Sri Lanka

Contacts

Public ContactGathsaurie Malavige

Senior Lecturer

gathsaurie.malavige@ndm.ox.ac.uk94772443193

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026