CTRI/2019/04/018435
Not yet recruiting
Phase 3
Profile of Dengue Fever and effect of carica papaya leaf extract capsule on platelet counts and clinical bleeding
Dinesh babu1 site in 1 country176 target enrollmentStarted: October 4, 2019Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dinesh babu
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- 1. To describe the clinical profile of dengue fever in adult patients admitted in PIMS
Overview
Brief Summary
As many physicians in india use carica papaya leaf extract capsule for improvement in platelet counts in dengue fever , but there are very few studies proving their benefit. Hence this study was done in my institution to study the effect of the drug.
Commercially available carica papaya leaf capsule is given as 1100 mg thrice daily for 5 days and hypothesised that it will increase or prevent fall in platelet counts in dengue fever and reduce hemorrhagic manifestations
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients aged more than 18 yrsadmitted with fever and dengue Ns1Ag (OR) IgM positive.
Exclusion Criteria
- •Patients with chronic liver disease
- •Patients with dengue co-infectionlike malaria , typhoid , scrub typhus.
- •Patient with platelet disorders (eg:Immune thrombocytopenic purpura)
- •Pregnant women with dengue fever.
Outcomes
Primary Outcomes
1. To describe the clinical profile of dengue fever in adult patients admitted in PIMS
Time Frame: 8 months
2. To determine the effect of carica papaya leaf extract capsuleon platelet counts in adult patients of dengue fever admitted in PIMS
Time Frame: 8 months
Secondary Outcomes
- Whether carica papaya leaf extract capsule reduce hemorrhagic manifestations(10 months)
Investigators
Study Sites (1)
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