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The efficacy of rupatadine in reducing the incidence of dengue haemorrhagic fever and complications in patients with dengue fever: a randomised, double blind, placebo controlled trial

Phase 2
Recruiting
Conditions
Dengue
Registration Number
SLCTR/2017/024
Lead Sponsor
niversity of Sri Jayewardenapura
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

1. Male and female patients aged between 18-60 years
2. Dengue infection confirmed by a positive dengue NS1 antigen detection test (rapid immununochromatographic assays (rapid strip tests) at the out patient department)
3. Duration of fever: <3 days
4. No evidence of vascular leak.

Exclusion Criteria

1. Known allergies to antihistamines

2. Inability to take the drugs orally

3. Known hepatic impairment defined as follows (all 3 criteria)

• History or clinical record of pre-existing liver disease

• Prolonged prothromin time of 4-6 seconds or more

• INR of >1.5

4. Known renal impairment defined as:

• History or clinical record of pre-existing renal disease, predicted GFR <60 ml/min per 1.73 m2, hereditary kidney disease or recurrent or extensive nephrolithiasis

5. Homelessness

6. Known alcohol dependence or drug abuse

7. Those with other pre-existing medical conditions that in the opinion of the investigators may impact the interpretation of the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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