Study on the effects of papaya leaf extract on plasma leakage and platelet count in dengue fever
Phase 2
- Conditions
- Dengue fever
- Registration Number
- SLCTR/2017/034
- Lead Sponsor
- Dr. RWK Kodokara Arachchi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1. Male and female patients aged between 14-70 years
2. Dengue fever confirmed by positive dengue antigen or specific IGM
3. Platelet count <150,000/microlitre
Exclusion Criteria
1. Plasma leak determined by ultrasonography
2. Pregnant or lactating
3. Decompensated cardiac failure as determined by clinical features
4. Ongoing renal or hepatic disease as determined by clinical features and lab investigations
5. BMI >35kg/m2
6. Known allergy to papaya
7. Previous history of bleeding or platelet disorders
8. Active peptic ulcer disease
9. Concurrent anticoagulant therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurrence and severity of plasma leakage <br><br>Occurrence of plasma leak will be determined ultrasonically. The severity of leak will be determined by the requirement of crystalloid and colloid boluses and blood transfusions. [Daily until complete recovery <br>Complete recovery will be defined as defervescence and rise of platelet count >75,000/microlitre ]<br>
- Secondary Outcome Measures
Name Time Method Severity of thrombocytopenia (absolute platelet count)<br> [Daily until complete recovery <br>Complete recovery will be defined as defervescence and rise of platelet count >75,000/microlitre ]<br>Derangement of liver transaminases (absolute serum AST and ALT) [Daily until complete recovery <br>Complete recovery will be defined as defervescence and rise of platelet count >75,000/microlitre ]<br>Duration of hospital stay [ ]<br>