None listed
Conditions
Interventions
Intervention1: Platenza Tablet: Dose: Two Tablets Twice Daily for a period of 10 days
Control Intervention1: Carica papaya leaf extract tablet: Dose: One Tablet three times daily for a period of 10 d
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female subjects between the age group of >=18 years to 2.Subjects who have been diagnosed with clinically significant dengue fever associated with thrombocytopenia with platelet count between 30000/µL to 1,00,000/µL. 3., subjects with the SGPT level not more than 2 times the upper limit of normal. 4.subjects with stable vitals like pulse and blood pressure 5.subjects willing to give written informed consent 6.subjects who had not participated in similar kind of study in last 3 months were included into the study.
Exclusion criteria
Exclusion criteria: 1. Subject diagnosed with DHF Grade 3 or 4, with hypotension / hypovolemia, subjects with platelet count 2.subjects presenting with hemorrhagic phenomena at screening evidenced with positive torniquette test, petechiae, ecchymoses, or purpura, bleeding from the oral mucosa, gastrointestinal tract, injection sites or other locations and haemetemesis or melaena. 3.subjects with dengue fever associated with any bleeding disorders or those taking blood thinning medications such as aspirin or warfarin. 4.subjects with the history of any severe metabolic disorders. 5.pregnant & lactating women 6.subjects not willing to sign informed consent form are excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete releif from clinical signs and symptoms of Dengue fever with normalization of platelet countsTimepoint: Study Specific Efficacy parameters - Platelet Counts - screening, Day 1, Day 2, Day 3, Day 4,Day 6, Day 8 and Day 10. Clinical Signs and Symptoms - Screening, Day 3, Day 6 and Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| No reported or observed adverse events with improved Quality of Life Good overall compliance to the study intervention.Timepoint: AE/SAE - Screening, Day3, Day 6, and Day 10 QOL - Screening and at the end of Day 10 (End of the Study) | — |
Countries
India
Contacts
Public ContactDr Srikrishna H A
The Himalaya Drug Company
Outcome results
None listed