A clinical trial to study the mechanism of action of papaya leaf extract in dengue patients

Phase 4

Not yet recruiting

• Conditions: non-severe dengue patients.

• Registration Number: CTRI/2014/10/005120
• Lead Sponsor: Jawaharlal Institute of Post graduate Medical Education and Research JIPMER

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2014-10-17
• Study Start: 2014-10-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

• Dengue fever group C and those with bleeding manifestations other than petechiae/purpura  Pregnant or lactating women.
• Known case with hepatic and renal diseases.
• Patients with inherited platelet disorders Patients on medications which interfere with platelet function (NSAIDs) will be excluded from the study.
• History of allergic reactions to papaya.
• Patients with more than 2 episodes of vomiting in the past 24 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
supplementation of papaya leaf extract to dengue patients increases platelet aggregation,decreases membrane fluidity and p-selectin expression	1st day, 3rd day and 7th day of start of intervention

Secondary Outcome Measures

Name	Time	Method
Improvement in platelet count and hematocrit value.	0,3rd and 7th day

Trial Locations

Locations (1)

Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER).; 🇮🇳 Pondicherry, PONDICHERRY, India

Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER).

🇮🇳Pondicherry, PONDICHERRY, India

Dr Soundravally Rajendiran

Principal investigator

soundy27@yahoo.co.in