CTRI/2020/01/022785
Not yet recruiting
Phase 2
An Open Label, Single Arm Clinical study To Evaluate The Safety and Efficacy of HPLT031707 SYRUP in Cases of Thrombocytopenia Associated With Dengue Fever in Pediatric Population - PL_S
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Himalaya Drug Company
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Both male and female pediatric subjects between the age group between \>\=2 years to \<\=12 years
- •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
- •1\)Pediatric subjects diagnosed with DHF Grade 3 or 4,with hypotension / hypovolemia and dehydration
- •2\)Pediatric subjects with platelet count \< 50000 cells/mm3
- •3\)Pediatric subjects weighing \<10 Kgs and \>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
Outcomes
Primary Outcomes
Not specified
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