Health Condition 1: A90- Dengue fever [classical dengue]
Conditions
Interventions
Intervention1: HPLT031707 Syrup: Dose as per kg body weight of the children between 2 to 12 years mentioned below
WEIGHT (Kgs) DOSE (mL) [Twice daily]
10-12 3 mL
13-15 4 mL
16-19
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1)Both male and female pediatric subjects between the age group between >=2 years to 2)Pediatric subjects already confirmed to have DF (Dengue Fever) through ELISA based NS1 Antigen test and/or IgM. 3)Pediatric subjects who have been clinically diagnosed with dengue fever associated with thrombocytopenia vis a vis platelet count between 50000 cells/mm3 to 1,00,000 cells/mm3. 4)Pediatric subjects with the SGPT level not more than twice the upper limit of the normal 5)Parents/Guardians/Caregiver related to pediatric subject willing to give written informed consent for his/her participation to the study 6)Pediatric subject aged > 7 years of age willing to sign the assent form for his/her participation in the study 7)Pediatric subjects who have not participated in this kind of trial in the past 4 weeks
Exclusion criteria
Exclusion criteria: 1)Pediatric subjects diagnosed with DHF Grade 3 or 4,with hypotension / hypovolemia and dehydration 2)Pediatric subjects with platelet count 3)Pediatric subjects weighing 45 Kgs 4)Pediatric subjects with any febrile condition with temperature >=103 degree ofF and with a history of any febrile seizures. 5)Pediatric subjects presenting with hemorrhagic phenomena at Day 1 (screening/baseline) evidenced with petechiae, ecchymoses, or purpura, bleeding from the oral mucosa, gastrointestinal tract (hemetemesis or melaena.), injection sites or other locations. 7)Pediatric subjects with the history of juvenile diabetes mellitus treated with medication. 8)Pediatric subjects with the history of clinically significant cardiovascular condition treated with medication 9)Pediatric subjects with history of UTI or acute or chronic infectious condition and on any antibiotics like polymyxin B, rifampicin, amikacin, nalidixic acid, gentamycin, cholarmphenicol, oflaxacin 10)Pediatric subjects with a history of established hematological disorders including idiopathic thrombocytopenia purpura, leukemia, hemophilia 11)Pediatric subjects who have received blood products or blood/platelet transfusion during the current hospital stay or during last one month 12)Pediatric subjects who are hypersensitive to any of the ingredients of the study medication 13)Pediatric subjects with a history of clinically significant systemic condition treated with aspirin or corticosteroids or heparin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in platelet counts as compared to day 0 to day 7.Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time taken to achieve a platelet count of 1.5 Lakh cells/mm3 2. Improvement in hematocrit value 3. Restoration of SGPT within normal levels. 4. Overall compliance of the subject to the study medication 5. To assess any adverse events reported or observed during the study period.Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactDr Palaniyamma
The Himalaya Drug Company
Outcome results
None listed