EFFECT OF CARICA PAPAYA LEAF EXTRACT ON PLATELET AGGREGATION, MEMBRANE FLUIDITY AND P-SELECTIN EXPRESSION IN DENGUE INFECTION: A RANDOMISED CONTROLLED TRIAL
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Jawaharlal Institute of Post graduate Medical Education and Research JIPMER
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- supplementation of papaya leaf extract to dengue patients increases platelet aggregation,decreases membrane fluidity and p-selectin expression
Overview
Brief Summary
40 patients with dengue infection(GroupI) and 20 controls(Group II) will bestudied and blood samples will be collected to estimate Platelet aggregation andits membrane fluidity and P-Selectin levels. Group I will be further dividedinto two groups as Group Ia and Group Ib. Group Ia will get supportivetreatment and Carica papaya leaf extract . Group Ib will get Supportivetreatment only. In case of Group I (Dengue) and Group II(Healthy subjects) five milliliter of blood sample will be collected. First sample will becollected for both Group I (Dengue) and Group II (Healthy subjects), within24-48 hrs of admission. 2nd and 3rd sample will becollected for Group I (Dengue) subjects only. 2nd sample will becollected at 3rd day of admission and third sample at 7rdday or at the time of discharge whichever is earlier. Blood samples will betested for P-Selectin,Platelet aggregation and Platelet membrane fluidity.Plateletaggregation will be expressed in percentage (%). Platelet membrane fluidity will be expressed in florescence units. Mean with standard deviation will be calculated forexpression of CD markers on platelets and ANOVA with Bonferroni test will beused for comparing means between the groups. A p value of <0.05 will beconsidered as statistically significant difference between the groups.Appropriate parametric ( Paired ’t’test) and non parametric (mann-whitney ’U’ test) will be used to compare thecontinuous variables between the groups.Thestudy protocol will conform to standard ethical guidelines.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ïƒ˜Dengue Fever Subjects 18-60 yrs positive for dengue NS1 antigen or anti IgM/IgG dengue antibodies or virus by Reverse Transcriptase PCR.
Exclusion Criteria
- •ïƒ˜Dengue fever group C and those with bleeding manifestations other than petechiae/purpura  Pregnant or lactating women.
- •ïƒ˜Known case with hepatic and renal diseases.
- •ïƒ˜Patients with inherited platelet disorders Patients on medications which interfere with platelet function (NSAIDs) will be excluded from the study.
- •ïƒ˜History of allergic reactions to papaya.
- •ïƒ˜Patients with more than 2 episodes of vomiting in the past 24 hours.
Outcomes
Primary Outcomes
supplementation of papaya leaf extract to dengue patients increases platelet aggregation,decreases membrane fluidity and p-selectin expression
Time Frame: 1st day, 3rd day and 7th day of start of intervention
Secondary Outcomes
- Improvement in platelet count and hematocrit value.(0,3rd and 7th day)